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Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma

NCT00406757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-11-13

No results posted yet for this study

Summary

In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small patient population. While the small number of patients presents a practical limitation to the size of a clinical trial, patients whose disease has not responded to or has relapsed after treatment with multiple prior chemotherapy regimens have no accepted standard therapies available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize the contribution of each available patient.

Conditions

  • Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic

Interventions

DRUG

Nelarabine injection 400mg/m2

Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5. Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5.

DRUG

Nelarabine injection 650mg/m2

Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.

DRUG

Nelarabine injection 1000mg/m2

Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5. Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.

DRUG

Nelarabine injection 1500mg/m2

Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-30
Primary Completion
2009-07-15
Completion
2009-07-15

Countries

  • Japan

Study Locations

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Entities

Companies

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 NCT00406757 on ClinicalTrials.gov