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506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
This study has been completed.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003545
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: nelarabine
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma
Drug Information available for: Nelarabine
U.S. FDA Resources
Study Type: Interventional
Study Design: 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)

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

Estimated Enrollment: 35
Study Start Date: August 1998
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.

PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 2.5-3 years, at a rate of 12-15 patients per year.

  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 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (unless due to leukemia) Renal: Creatinine clearance at least 50 mL/min (unless due to leukemia) Neurologic: 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 Other: No history of seizure disorder Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent erythropoietin Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent dexamethasone or other steroidal antiemetics No concurrent hormone therapy, except for non-disease-related conditions Radiotherapy: See Disease Characteristics Surgery: Not specified

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Deangelo DJ, Yu D, Johnson JL, Coutre SE, Stone RM, Stopeck AT, Gockerman JP, Mitchell BS, Appelbaum FR, Larson RA. Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: cancer and leukemia group B study 19801. Blood. 2007 Mar 7; [Epub ahead of print]
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.

Study ID Numbers: CDR0000066600, CLB-19801, SWOG-C19801
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003545  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Leukemia-Lymphoma, Adult T-Cell
Lymphoblastic lymphoma
Recurrence
Acute lymphoblastic leukemia, adult
Leukemia
Lymphatic Diseases
Leukemia, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009