protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT00628745 | 2 | LIST OF ABBREVIATIONS | | Abbreviation | Definition | | | |
|---------------------|----------------------------------------------------------------------------------------------------------|--|--|--|
| AE | Adverseevent ... | [] |
NCT00628745 | 3 | RESPONSIBLE PARTIES |
The contact details for the Principal Investigators in the Transthyretin Amyloidosis Outcomes Survey (THAOS) are available upon request.
The contact details for the Principal Investigators who serve as the Country Coordinating Investigators in the Transthyretin Amyloidosis Outcomes Survey (THAOS) are available upon ... | [
"Principal Investigator(s) of the Protocol",
"Country Coordinating Investigators"
] |
NCT00628745 | 4 | ABSTRACT | Transthyretin Amyloidosis Outcomes Survey (THAOS): A Global, Multi-Center, Longitudinal, Observational Survey of Patients With Documented Transthyretin Gene Mutations or Wild-Type Transthyretin Amyloidosis (Amendment 5; 13 July 2020, PPD )
RATIONALE AND BACKGROUND: Transthyretin (TTR) amyloidosis is a rare disease ca... | [] |
NCT00628745 | 5 | AMENDMENTS AND UPDATES | | AmendmentNumber | Date | Substantial orAdministrativeAmendment | ProtocolSection(s)Changed | Summary ofAmendment(s) ... | [] |
NCT00628745 | 6 | MILESTONES | | Milestone | Planned date |
|------------------------------------------------------------|-------------------------------------------------------------|
| Start of data collection (First Subject First Visit: FSFV) | 16 Dece... | [] |
NCT00628745 | 7 | RATIONALE AND BACKGROUND | [] | |
NCT00628745 | 7.1 | Disease Background | Transthyretin (TTR) a 127-amino acid, tetrameric protein, primarily synthesized in the liver, is a secreted protein present in the blood and cerebrospinal fluid and is a carrier of thyroxine and retinol-binding protein-retinol (vitamin A) complex. Transthyretin amyloidosis (ATTR amyloidosis) is a rare disease caused by... | [
"ATTR-PN",
"ATTR-CM"
] |
NCT00628745 | 7.2 | Rationale for the Survey | The Transthyretin Amyloidosis Outcomes Survey (THAOS) is a longitudinal, observational survey open to all patients with TTR gene mutations without a diagnosis of ATTR amyloidosis and to patients diagnosed with ATTR amyloidosis (inclusive of ATTR-PN and ATTR-CM). To date, limited data are available on the natural histor... | [] |
NCT00628745 | 7.3 | Role of THAOS in the Tafamidis European Union Post-Marketing Commitment | On 21 July 2011 the European Union (EU) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product tafamidis 20 mg capsule intended for the treatment of ATTR amyloidosis in adult patients with Stage 1 symptomatic pol... | [] |
NCT00628745 | 8 | RESEARCH QUESTION AND OBJECTIVES | The objectives of THAOS are to:
- Describe the population of patients affected with ATTR amyloidosis;
- Enhance the understanding of disease natural history, including the variability and progression of the hereditary and acquired forms of the disease;
- Better understand the genotype phenotype relationship in ATTRm.;... | [] |
NCT00628745 | 9 | RESEARCH METHODS | [] | |
NCT00628745 | 9.1 | Study Design | THAOS is a non-interventional, global, multi-center, longitudinal observational survey open to all patients with ATTR amyloidosis, including both inherited and wild-type forms of disease, and participants with TTR gene mutations without disease diagnosis. There is no set number of patients who will be enrolled. The stu... | [] |
NCT00628745 | 9.1.1 | Study Treatment and Duration | THAOS has been open since 2007. There is no set number of patients who will be enrolled in the survey. Patients will be enrolled from different countries around the world. All patients who take part in this survey will be followed until the survey is declared complete by Pfizer (currently estimated to be the year 2023)... | [] |
NCT00628745 | 9.2 | Setting | The study population includes patients with confirmed genotyped TTR mutation with or without a diagnosis of hereditary or wild-type ATTR amyloidosis.
Assessments were proposed by a team of experts as components of standard clinical practice for patients with ATTR amyloidosis and are recommended but are not required; t... | [] |
NCT00628745 | 9.2.1 | Inclusion Criteria | Patients must meet all of the following inclusion criteria to be eligible for inclusion into THAOS:
- 1. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- 2. Males and femal... | [] |
NCT00628745 | 9.2.2 | Exclusion Criteria | Patients meeting any of the following will not be included in the study:
1. Patient has primary or secondary amyloidosis. | [] |
NCT00628745 | 9.2.3 | Genotyping | TTR genotyping is required to confirm patient eligibility and will be performed before the Eligibility/Baseline visit and outside of the auspices of the survey according to the site's standard practices. For patients with a documented TTR gene mutation, the mutation(s) will be recorded in the patient's medical record a... | [] |
NCT00628745 | 9.3 | Variables | The objectives of THAOS are to describe the population of patients affected with ATTR amyloidosis and to enhance the understanding of the disease natural history, including the variability and progression of the hereditary and acquired forms of disease.
All visits are intended to be outpatient visits. Assessments are ... | [] |
NCT00628745 | 9.3.1 | Study Assessments | - Written informed consent/assent.
- Inclusion/exclusion criteria.
- Patient demographics (year of birth, gender, ethnic origin, race (if allowed by local regulations).
- TTR genetic test results.
- Family disease history (previous family history of ATTR amyloidosis).
- Medical history (past and current signs, symptom... | [] |
NCT00628745 | 9.3.2 | Safety Assessments | AE/SAE data collected in THAOS will be used to further characterize the safety profile of tafamidis and as a result, to fulfill certain aspects of the EU post-marketing commitment for tafamidis. Based on the safety concerns detailed in [Table 1,](#page-25-1) corresponding data for Events of Interest will be collected t... | [] |
NCT00628745 | 9.3.3 | Eligibility/Baseline Visit | This visit will be performed to determine a patient's eligibility. It includes obtaining informed consent, chart review to determine eligibility, and recording results of study assessments as outlined in [Section 9.3.1](#page-23-1) Study Assessments. | [] |
NCT00628745 | 9.3.4 | Return Visit | Return visits will, on average, be conducted annually or more frequently at the discretion of the survey physician. The reporting window for collecting changes in signs, symptoms, AE information, and new diagnoses is from the last prior visit. | [] |
NCT00628745 | 9.3.5 | Retrospective Visit | Any assessments listed in [Section 9.3.1](#page-23-0) Study Assessments and performed prior to the patient's Eligibility/Baseline visit may be entered into the THAOS electronic data record as retrospective visit data. This data collection is optional. | [] |
NCT00628745 | 9.3.6 | Final Visit | Final visit data collection, including collection of AE/SAE information, will be performed at the completion of the survey, or at the time a patient dies or elects to discontinue from the survey, whichever occurs first. If a patient dies while enrolled in the survey, the site is asked to collect all available informati... | [] |
NCT00628745 | 9.4 | Data Sources | The THAOS electronic data record allows for data to be recorded from an eligibility/baseline visit, at return visits, and in the form of status updates, if the patient has not visited the site. In addition, THAOS physicians have the option of recording pre-baseline retrospective patient data. Final data entry (the entr... | [] |
NCT00628745 | 9.5 | Study Size | THAOS has been open since 2007. There is no set number of patients who will be enrolled in the survey. Patients will be enrolled from different countries around the world. All patients who take part in this survey will be followed until the survey is declared complete by Pfizer (currently estimated to be the year 2023)... | [] |
NCT00628745 | 9.6 | Data Management | [] | |
NCT00628745 | 9.6.1 | Case Report Forms (CRFs)/Data Collection Tools (DCTs)/Electronic Data Record | As used in this protocol the term CRF should be understood to refer to either a paper form or an electronic data record or both, depending on the data collection method used in this study.
A computer-based application will be used for entering data into the THAOS electronic data record, allowing sites to enter data re... | [] |
NCT00628745 | 9.6.2 | Record Retention | To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the investigator agrees to keep records, including the identity of all participating patients (sufficient information to link records, eg, CRFs and hospital records), all original signed informed consent documents, copies of all CRFs... | [] |
NCT00628745 | 9.7 | Data Analysis | [] | |
NCT00628745 | 9.7.1 | Statistical Methods | Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP), which will be dated, filed and maintained by the sponsor. The SAP may modify the plans outlined in the protocol; any major modifications of primary endpoint definitions or t... | [] |
NCT00628745 | 9.7.2 | Data Summaries | THAOS data will be available for analysis on 3 different levels: by patient, by individual survey site, and across survey sites.
The primary objective of the survey is to better understand the natural history of ATTR (hereditary and wild-type forms) and the progression of disease in this patient population. Analysis o... | [] |
NCT00628745 | 9.7.3 | Scientific Board | The Scientific Board is comprised of a group of scientific and clinical experts in the field of amyloid disease who will provide scientific oversight and interpretation of the data originating from THAOS and its sub-studies. The role of the Board is to develop treatment recommendations and practice guidelines for patie... | [] |
NCT00628745 | 9.7.4 | Interim Analyses | There is no formal interim analysis planned.
Safety data required as part of the European Medicines Agency RMP for tafamidis will be analyzed and submitted annually.
One or more data extracts will be performed annually in order to support ad hoc analyses for publications and for pricing and reimbursement. | [] |
NCT00628745 | 9.8 | Quality Control | [] | |
NCT00628745 | 9.8.1 | Data Editing | Data entered into the THAOS electronic clinical database will be automatically checked according to the database specifications, focusing on data critical for analysis, using limits set within the programming. Error messages will appear notifying the sites of discrepancies as they are identified or at the point of data... | [] |
NCT00628745 | 9.8.2 | Audits | Local or international regulatory authorities, the IRB/EC, the Sponsor, or its designee, may request access to all patient consent forms, source documents, THAOS electronic data records, and other survey documentation for on-site audit or inspection. Direct access to these documents must be guaranteed by the investigat... | [] |
NCT00628745 | 9.8.3 | THAOS Electronic Clinical Database | The investigator has ultimate responsibility for the collection and reporting of all clinical, safety, and laboratory data entered in the THAOS electronic clinical database from source documents (eg, hospital or physician patient charts), physical examinations, and patient reports. The investigator must ensure that the... | [] |
NCT00628745 | 9.9 | Limitations of the Research Methods | The observational nature of this study has the potential to introduce selection or ascertainment bias. The study population could be more heterogeneous. Confounding leads to biased estimates of associations of risk factors or treatment with outcome and thus impacts the validity of the conclusions from the study. Analyt... | [] |
NCT00628745 | 9.10 | Other Aspects | Not Applicable. | [] |
NCT00628745 | 10 | PROTECTION OF HUMAN SUBJECTS | [] | |
NCT00628745 | 10.1 | Patient Information | All parties will comply with all applicable laws, including laws regarding the implementation of organizational and technical measures to ensure protection of patient personal data. Such measures will include omitting patient names or other directly identifiable data in any reports, publications, or other disclosures, ... | [] |
NCT00628745 | 10.2 | Patient Consent | The informed consent/assent documents and any patient recruitment materials must be in compliance with local regulatory requirements and legal requirements, including applicable privacy laws.
The informed consent/assent documents used during the informed consent process and any patient recruitment materials must be re... | [] |
NCT00628745 | 10.2.1 | Participation in Investigational Clinical Trials | If a patient in Spain elects to participate in a double-blind or open-label interventional trial, entry of data into THAOS will be prohibited from the date patient begins taking study drug (or device) until the end of the interventional trial. Data collected prior to a patient receiving treatment in a double-blind or o... | [] |
NCT00628745 | 10.3 | Patient Withdrawal | Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, or administrative reasons. In any circumstance, every effort should be made to document patient outcome, if applicable. The investigator wo... | [] |
NCT00628745 | 10.4 | Institutional Review Board (IRB)/Independent Ethics Committee (IEC) | It is the responsibility of the investigator to have prospective approval of the study protocol, protocol amendments, and informed consent forms, and other relevant documents, (eg, recruitment advertisements), if applicable, from the IRB/IEC. All correspondence with the IRB/IEC should be retained by the investigator. C... | [] |
NCT00628745 | 10.5 | Ethical Conduct of the Study | The study will be conducted in accordance with legal and regulatory requirements, as well as with scientific purpose, value and rigor and follow generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the International Society for Pharmacoepidemiology (ISPE)... | [] |
NCT00628745 | 11 | MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS FOR TAFAMIDIS-TREATED SUBJECTS | [] | |
NCT00628745 | 11.1 | Requirements | The table below summarizes the requirements for recording safety events in the THAOS electronic data record and for reporting safety events on the non-interventional study (NIS) adverse event monitoring (AEM) Report Form to Pfizer Safety. These requirements are delineated for 3 types of events: (1) serious adverse even... | [] |
NCT00628745 | 11.2 | Reporting Period | For each patient, the safety event reporting period begins at the time of the patient's first dose of tafamidis or the time of the patient's informed consent if s/he is being treated with tafamidis at study start and lasts through the end of the observation period of the study, which must include at least 28 calendar d... | [] |
NCT00628745 | 11.3 | Causality Assessment | The investigator is required to assess and record the causal relationship.
For all AEs, sufficient information should be obtained by the investigator to determine the causality of each AE. For AEs with a causal relationship to tafamidis, follow-up by the investigator is required until the event and/or its sequelae res... | [] |
NCT00628745 | 11.4 | Definitions of Safety Events | [] | |
NCT00628745 | 11.4.1 | Adverse Events | An AE is any untoward medical occurrence in a patient administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Examples of AEs include but are not limited to:
- Abnormal test findings (see below for circumstances in which an abnormal test finding ... | [] |
NCT00628745 | 11.4.2 | Abnormal Test Findings | The criteria for determining whether an abnormal objective test finding should be reported as an AE are as follows:
- • Test result is associated with accompanying symptoms, and/or
- Test result requires additional diagnostic testing or medical/surgical intervention, and/or
- Test result leads to a change in study dos... | [] |
NCT00628745 | 11.4.3 | Serious Adverse Events | A SAE is any untoward medical occurrence in a patient administered a medicinal or nutritional product (including pediatric formulas) at any dose that:
- Results in death;
- Is life-threatening (immediate risk of death);
- Requires inpatient hospitalization or prolongation of hospitalization (see below for circumstance... | [] |
NCT00628745 | 11.5 | Hospitalization | Hospitalization is defined as any initial admission (even if less than 24 hours) to a hospital or equivalent healthcare facility or any prolongation to an existing admission. Admission also includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric wing to a medical floor, medical f... | [] |
NCT00628745 | 11.6 | Scenarios Necessitating Reporting to Pfizer Safety within 24 Hours | Scenarios involving exposure during pregnancy, exposure during breastfeeding, medication error, overdose, misuse, extravasation, lack of efficacy, and occupational exposure are described below. | [] |
NCT00628745 | 11.6.1 | Exposure During Pregnancy | - 1. An exposure during pregnancy (EDP) occurs if a female becomes, or is found to be, pregnant either while receiving or having been directly exposed to (eg, environmental exposure) tafamidis, or the female becomes, or is found to be, pregnant after discontinuing and/or being directly exposed to tafamidis (maternal ex... | [] |
NCT00628745 | 11.6.2 | Exposure During Breastfeeding | Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of an associated AE. An exposure during breastfeeding report is not created when a Pfizer drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in accord with authorized use. However, if the infa... | [] |
NCT00628745 | 11.6.3 | Medication Error | A medication error is any unintentional error in the prescribing, dispensing or administration of a medicinal product that may cause or lead to inappropriate medication use or patient harm while in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, he... | [
"Medication errors include:"
] |
NCT00628745 | 11.6.4 | Overdose, Misuse, Extravasation | Reports of overdose, misuse, and extravasation associated with the use of a Pfizer product are reported to Pfizer by the investigator, irrespective of the presence of an associated AE/SAE. | [] |
NCT00628745 | 11.6.5 | Lack of Efficacy | Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the investigator, irrespective of the presence of an associated AE/SAE or the indication for use of the Pfizer product. | [] |
NCT00628745 | 11.6.6 | Occupational Exposure | Reports of occupational exposure to a Pfizer product are reported to Pfizer by the investigator, irrespective of the presence of an associated AE/SAE. | [] |
NCT00628745 | 11.7 | Single Reference Safety Document | The Core Data Sheet will serve as the single reference safety document during the course of the study, which will be used by Pfizer safety to assess any safety events reported to Pfizer Safety by the investigator during the course of this study.
The Product Label should continue to be used by the investigator for pres... | [] |
NCT00628745 | 12 | PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS | [] | |
NCT00628745 | 12.1 | Communication and Publication of Study Results | In the event of any prohibition or restriction imposed (eg, All information in the protocol and other documents provided to the survey physician and survey team are privileged and confidential information. The physician will use this information to accomplish the survey and will not use it for publication without writt... | [] |
NCT00628745 | 13 | References | - 1. Connelly S, Choi S, Johnson SM, et al. Structure based design of kinetic stabilizers that ameliorate the transthyretin amyloidoses. Curr Opin Struct Biol 2010; 20(1):54-62.
- 2. Klabunde T, Petrassi HM, Oza VB, et al. Rational design of potent human transthyretin amyloid disease inhibitors. Nat Struct Biol 2000; 7... | [] |
NCT00628745 | 14 | LIST OF TABLES | Table 1. [Summary of Safety Concerns to be Assessed](#page-25-1) in THAOS.........................26 | [] |
NCT00628745 | 15 | LIST OF FIGURES | None.
None.
This annex is not required.
See Patient Reported Outcome Questionnaires below.
| CCI | | |
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| | | |
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| | | |
| | | |... | [
"ANNEX 1. LIST OF STAND-ALONE DOCUMENTS",
"ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS",
"ANNEX 3. ADDITIONAL INFORMATION",
"Document Approval Record"
] |
NCT01990534 | 1 | BACKGROUND AND STUDY RATIONALE | [] | |
NCT01990534 | 1.1 | Scientific Background | CD30 is a cell surface antigen expressed on several malignancies including Hodgkin lymphoma (HL), some mature T cell lymphoma (MTCL) subtypes, including anaplastic large cell lymphoma (ALCL), Kaposi sarcoma (KS), cutaneous T cell lymphomas (CTCL), a fraction of diffuse large B-cell lymphomas (DLBCL), some follicular ly... | [] |
NCT01990534 | 1.1.1 | Relapsed or Refractory Hodgkin Lymphoma | Hodgkin lymphoma is a malignancy involving the lymph nodes and lymphatic system. The World Health Organization (WHO) divides HL into 2 main types: classical HL (CHL), which accounts for 95% of reported cases and lymphocyte-predominant HL (LPHL), which accounts for 5% of reported cases. CHL is histopathologically define... | [] |
NCT01990534 | 1.1.2 | Brentuximab Vedotin | Brentuximab vedotin (ADCETRIS ® ) is an ADC directed against the CD30 antigen. It is composed of the anti-CD30 chimeric immunoglobulin G1 (IgG1) monoclonal antibody cAC10 and the potent antimicrotubule drug monomethyl auristatin E (MMAE) connected by a protease-cleavable linker. cAC10 binds to the CD30 antigen, which h... | [] |
NCT01990534 | 1.2 | Preclinical Experience | Brentuximab vedotin has the potential to target and selectively deliver the microtubule-disrupting agent MMAE to CD30-expressing tumor cells. In vitro, cytotoxicity studies showed that it selectively killed human CD30+ HL and ALCL cells with nanomolar concentrations producing 50% inhibition (IC50 values). Antitumor act... | [] |
NCT01990534 | 1.3 | Clinical Experience | The accelerated approval of brentuximab vedotin in the USA and conditional approval in the EU was obtained on the basis of results from 6 completed phase 1 and phase 2 clinical studies, conducted in patients with CD30+ hematologic malignancies. A total of 357 patients received at least 1 dose of brentuximab vedotin in ... | [
"Phase 1, Dose-Escalation Studies",
"Phase 2 Studies"
] |
NCT01990534 | 1.3.1 | Patients With Relapsed or Refractory HL and No Prior Autologous Stem Cell Transplantation | Limited data are available on the efficacy and safety of brentuximab vedotin in transplant-naïve patients with relapsed or refractory classical HL. However, a retrospective analysis was performed on data from 41 patients with relapsed or refractory HL who had not received a prior ASCT and received brentuximab vedotin 1... | [] |
NCT01990534 | 1.4 | Study Rationale | Brentuximab vedotin has demonstrated a compelling level of antitumor activity in terms of ORR (CR + PR) and CR rates in several studies conducted in patients with relapsed or refractory HL. Meta analyses based on CR rate, an endpoint associated with long-term clinical benefit in patients with HL, suggest that brentuxim... | [] |
NCT01990534 | 1.5 | Potential Risks and Benefits | Brentuximab vedotin monotherapy was granted accelerated approval in the USA and conditional marketing authorization in the EU on the basis of results from 6 completed clinical studies, including two pivotal phase 2 studies, which showed a high rate of durable responses for patients with CD30+ hematological malignancies... | [] |
NCT01990534 | 2 | STUDY OBJECTIVES | [] | |
NCT01990534 | 2.1 | Primary Objective | The primary objective of the study is to assess the antitumor efficacy, as determined by the ORR of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, in patients with relapsed or refractory classical HL who are considered to be not suitable for SCT or multiagent chemotherapy. Pro... | [] |
NCT01990534 | 2.2 | Secondary Objectives | The secondary objectives are:
To determine the duration of tumor control, including the duration of response (DOR), PFS, and CR rate, by IRF assessment after treatment with brentuximab vedotin
f Use
- To determine the proportion of patients who receive hematopoietic SCT, either ASCT or allogeneic stem cell transpl... | [] |
NCT01990534 | 2.3 | Tertiary/Exploratory Objectives |  | [] |
NCT01990534 | 3 | STUDY ENDPOINTS | [] | |
NCT01990534 | 3.1 | Primary Endpoint Property of Takeda: For | The primary endpoint of the study is ORR (CR + PR), by IRF assessment.([1\)](#page-70-0) | [] |
NCT01990534 | 3.2 | Secondary Endpoints | The secondary endpoints are:
Duration of response, PFS, CR rate, and duration of CR, by IRF assessment
- Proportion of patients who receive SCT after treatment with brentuximab vedotin
- OS
- Incidence, severity, and relatedness of AEs; SAEs; and clinical laboratory abnormalities
- PK for brentuximab vedotin, MMAE, a... | [] |
NCT01990534 | 3.3 | Tertiary/Exploratory Endpoints |  | [] |
NCT01990534 | 4 | STUDY DESIGN | [] | |
NCT01990534 | 4.1 | Overview of Study Design | This phase 4, single-arm, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin in adult patients 18 years or older with histologically confirmed CD30+ relapsed or refractory classical HL who have not received a prior ASCT and are considered to be not suitable for SCT or multiagent ch... | [] |
NCT01990534 | 4.2 | Number of Patients | At least 60 patients with relapsed or refractory classical HL who are considered to be not suitable for SCT or multiagent chemotherapy will be enrolled in this study at approximately 20 investigative sites in Europe and potentially other regions of the world. Patients who are enrolled in the interactive voice response ... | [] |
NCT01990534 | 4.3 | Duration of Study | Study enrollment is expected to take approximately 15 months. Patients will complete a Screening period of up to 28 days and may receive a maximum of 16 cycles of brentuximab vedotin. Patients will be followed for 30 days ( 7 days) after administration of the last dose of brentuximab vedotin to permit the detection of ... | [] |
NCT01990534 | 5 | STUDY POPULATION | [] | |
NCT01990534 | 5.1 | Inclusion Criteria | Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- 1. Male or female patients 18 years or older.
- 2. A diagnosis of relapsed or refractory classical HL, confirmed by biopsy if clinically feasible on the basis of local pathology review.
- 3. A history of at least 1 prior syst... | [] |
NCT01990534 | 5.2 | Exclusion Criteria | Patients who meet any of the following exclusion criteria are not to be enrolled in the study:
- 1. Previous treatment with brentuximab vedotin.
- 2. Previously received an ASCT or alloSCT.
- 3. Female patients who are lactating and breastfeeding or have a positive serum or urine pregnancy test during the Screening pe... | [] |
NCT01990534 | 6 | STUDY DRUG | [] | |
NCT01990534 | 6.1 | Study Drug Administration | All protocol-specific criteria for administration of study drug must be met and documented prior to drug administration. Study drug will be administered only to eligible patients under the supervision of the investigator or identified subinvestigator(s).
Brentuximab vedotin will be administered on Day 1 of each 3-week... | [] |
NCT01990534 | 6.2 | Dose-Modification Guidelines | [] | |
NCT01990534 | 6.2.1 | Recommended Brentuximab Vedotin Dose Modifications for Treatment-associated Toxicity | Table 6-1 describes the recommended dose modifications for brentuximab vedotin for treatment-associated toxicity.
Table 6-1 Dose Modification Guidelines for Brentuximab Vedotin for Treatment-Associated Toxicity
| | Nonhematologic(Excluding Neuropathy) ... | [] |
NCT01990534 | 6.2.2 | Criteria for Dose Interruption During a Cycle | Please refer to Table 6-1 for instructions on the criteria to determine the requirement for a dose interruption.
f Use
a Patients who develop clinically insignificant Grade 3 or Grade 4 electrolyte laboratory abnormalities may continue study treatment without interruption.
b Patients who develop clinically insignifi... | [] |
NCT01990534 | 6.2.3 | Criteria for Beginning or Delaying a Subsequent Treatment Cycle | The cycle length for treatment with brentuximab vedotin will be 3 weeks. For a new cycle of treatment to begin, all drug-related toxicity must have resolved, according to the guidelines presented in [Table](#page-37-0) 6-1.
If the patient fails to meet the criteria for treatment at the scheduled time for the next cycl... | [] |
NCT01990534 | 6.2.4 | Criteria for Dose Reduction | Intrapatient dose reduction to 1.2 mg/kg may be allowed depending on the type and severity of toxicity (as previously described in [Table](#page-37-0) 6-1) and after the sponsor and investigator review the available data for that patient.
After a dose has been reduced for a patient because of drug-related toxicity, th... | [] |
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