Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Published Results
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 16 and over NCI CLB-19801 SWOG-C19801

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.

Entry 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

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

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

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.

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Daniel DeAngelo, MD, PhD, Protocol chair		Ph: 617-632-2645 Email: ddeangelo@partners.org

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