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

NCT01626664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-04-25

Study results available
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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).

Conditions

  • Adult T-cell Leukemia-Lymphoma

Interventions

BIOLOGICAL

KW-0761

1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

DRUG

Pralatrexate

30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

DRUG

gemcitabine plus oxaliplatin

gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DRUG

DHAP

dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Kurman, MD · Kyowa Hakko Kirin Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-08-31
Completion
2018-02-28

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Peru
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01626664 on ClinicalTrials.gov