506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Southwest Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003545
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: April 2007

November 1, 1999
February 4, 2013
August 1998
March 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003545 on ClinicalTrials.gov Archive Site
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Not Provided
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506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)

Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5).

II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.

OUTLINE:

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
Drug: nelarabine
Experimental: Arm I
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
Intervention: Drug: nelarabine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
Not Provided
March 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL)
  • Leukemia or lymphoma cells should express at least two of the following cell surface antigens: CD1a, CD2, CD3 (surface or cytoplasmic), CD4, CD5, CD7, and CD8
  • Leukemia cells should be negative for myeloperoxidase or Sudan Black B If the only T cell markers present are CD4 and CD7, the leukemic cells should be demonstrated to lack the myeloid markers CD33 and/or CD13
  • Refractory to at least one induction treatment regimen or in first or later relapse after achieving a complete remission
  • No CNS leukemia or lymphoma requiring intrathecal or craniospinal radiotherapy

PATIENT CHARACTERISTICS:

  • Age: 16 and over
  • Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia)
  • Creatinine clearance at least 50 mL/min (unless due to leukemia)
  • No neurologic toxicity of grade 3 or greater during prior treatment of ALL/LBL
  • No preexisting neuropathy of grade 2 or greater regardless of causality
  • No history of seizure disorder
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No concurrent erythropoietin
  • No other concurrent chemotherapy
  • No concurrent dexamethasone or other steroidal antiemetics
  • No concurrent hormone therapy, except for non-disease-related conditions
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003545
NCI-2012-01840, CLB-19801, SWOG-C19801, CDR0000066600
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Southwest Oncology Group
Study Chair: Daniel DeAngelo, MD, PhD Dana-Farber Cancer Institute
Study Chair: Steven E. Coutre, MD Stanford University
National Cancer Institute (NCI)
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP