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A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)

Phase 2
16 Years
Not Enrolling

Thank you

Trial Information

A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)


- Assess the complete remission rate in patients with recurrent or refractory non-T-cell
acute lymphocytic leukemia when treated with 506U78.

- Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21
days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6
months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18

Inclusion Criteria


- Diagnosis of acute lymphocytic leukemia (ALL)

- FAB class L1-L2

- Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in
peripheral blood, bone marrow, or in at least 1 extramedullary disease site)

- Coexpression of myeloid antigens CD13 or CD33 allowed

- Histologically confirmed extramedullary disease in the absence of bone marrow or
blood involvement allowed

- CD3 and myeloperoxidase marker negative

- Meeting 1 of the following criteria for recurrent/refractory disease:

- Refractory to standard induction regimen including at least vincristine and

- Recurrence after response after prior induction therapy

- Recurrence and failure on subsequent treatment

- No CNS involvement

- Must be registered on SWOG-S9910 and SWOG-9007



- 16 and over

Performance status:

- Zubrod 0-3

Life expectancy:

- Not specified


- Not specified


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 3 times ULN


- Creatinine no greater than 2 times ULN


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No grade 2 or greater neuropathy

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other
adequately treated stage I or II cancer in complete remission


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

After induction therapy is completed

Safety Issue:


Principal Investigator

Steven E. Coutre, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

July 2004

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • B-cell adult acute lymphoblastic leukemia
  • non-T, non-B adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



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