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NCT01626664 · ClinicalTrials.gov registry record · Phase 2
KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
A Phase 2 study of Adult T-cell Leukemia/Lymphoma, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 20
- Study locations
NCT01626664: Completed Phase 2 study of Adult T-cell Leukemia/Lymphoma, sponsored by Kyowa Kirin.
NCT01626664 is a Phase 2 study of Adult T-cell Leukemia/Lymphoma that has completed, run by Kyowa Kirin. The registered enrollment target is 71 participants, above the 45-participant average among 8 other Adult T-cell Leukemia/Lymphoma trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01626664, a Phase 2 study of Adult T-cell Leukemia/Lymphoma, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).
Primary Outcome
Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = \> 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other c
Conditions Studied
Interventions
- DRUG Pralatrexate
- BIOLOGICAL KW-0761
- DRUG gemcitabine plus oxaliplatin
- DRUG DHAP
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- Hospital Universitario Professor Edgard Santos- UFBA - Salvador, Bahia
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Sao Paulo- SP
- CHU de Fort de France - Fort de France Cedex
- Hospital Necker - Paris
- Hospital Nacional Edgardo Rebagliati Martins - Lima
- Instituto Oncologico Miraflores - Lima
- Guy's Hospital - London
- Imperial College - London
- Sandwell General Hospital - West Midlands
New York
- Memorial Sloan Kettering - New York
- Columbia Presbyterian - New York
- Weill Cornell Medical College - New York
- Montefiore Medical Center - The Bronx
California
- Cedars-Sinai Medical Center - Los Angeles
Florida
- University of Miami / Sylvester Comprehensive Cancer Center - Miami
Illinois
- Northwestern University - Chicago
Maryland
- National Cancer Institute - Bethesda
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2012-06 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
What the finished NCT01626664 record still lists
NCT01626664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 45-participant average among 8 other Adult T-cell Leukemia/Lymphoma trials with a reported enrollment target (58% higher).
The record links to 1 condition, with Adult T-cell Leukemia/Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Pralatrexate is the first listed.
NCT01626664 names 20 study sites across 8 states, led by Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT01626664 about?
NCT01626664 is a clinical study titled "KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)". The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).
What is the current status of trial NCT01626664?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2012-06. Estimated completion is 2018-02.
What conditions does trial NCT01626664 study?
This clinical trial studies the following conditions: Adult T-cell Leukemia/Lymphoma.
What interventions are being tested in trial NCT01626664?
The interventions under investigation include: Pralatrexate (DRUG), KW-0761 (BIOLOGICAL), gemcitabine plus oxaliplatin (DRUG), DHAP (DRUG).
Who is sponsoring clinical trial NCT01626664?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01626664 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01626664's enrollment target sits among peer trials
71 2nd of 8 the highest of 8 other Adult T-cell Leukemia/Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult T-cell Leukemia/Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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