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COMPLETED Phase 2

KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

NCT01626664 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 71 participants
Start Date 2012-06
Est. Completion 2018-02
Phase Phase 2

Sponsor

Kyowa Kirin

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01626664

The ClinicalTrials.gov registry entry for NCT01626664 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01626664 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01626664?

The interventions under investigation include: Pralatrexate (DRUG), KW-0761 (BIOLOGICAL), gemcitabine plus oxaliplatin (DRUG), DHAP (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01626664?

This trial is sponsored by Kyowa Kirin, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial