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
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: nelarabine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 35
Study Start Date: August 1998
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: nelarabine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003545

  Show 91 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Daniel DeAngelo, MD, PhD Dana-Farber Cancer Institute
Study Chair: Steven E. Coutre, MD Stanford University
  More Information

Additional Information:
Publications:
De Angelo DJ, Yu D, Dodge RK, et al.: A phase II study of 2-amino-9-b-D-arabinosyl-6-methoxy-9H-purine (506U78) in patients with relapsed or refractory T-Lineage acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL): CALGB study 19801. [Abstract] Blood 100 (11 Pt 1): A-743, 2002.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003545     History of Changes
Other Study ID Numbers: NCI-2012-01840, CLB-19801, SWOG-C19801, CDR0000066600
Study First Received: November 1, 1999
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia
recurrent childhood lymphoblastic lymphoma
recurrent adult acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014