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Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

NCT00981799 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-10-01

Study results available
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Summary

Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.

Conditions

  • Relapsed T-Cell Acute Lymphoblastic Leukemia
  • Relapsed T-Cell Lymphoblastic Lymphoma

Interventions

DRUG

Nelarabine

Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.

DRUG

Etoposide

100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5

DRUG

Cyclophosphamide

Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.

DRUG

Methotrexate

Give between day 29 and 36 or when ANC\>750 and PLTS\>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation. Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but \<2 years of age 10 mg for patients age greater than or equal to 2, but \<3 years of age 12 mg for patients greater than or equal to 3, but \< 9 years of age 15 mg for patients greater than or equal to \>9 years of age

DRUG

Filgrastim

5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is \> 1000/mm3 for two consecutive days.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Therapeutic Advances in Childhood Leukemia Consortium

    lead OTHER

Principal Investigators

  • Jim Whitlock, MD · The Hospital for Sick Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-11-30
Completion
2016-07-18

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT00981799 on ClinicalTrials.gov