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A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)

Phase 2
16 Years
Not Enrolling
Leukemia, Lymphoma

Thank you

Trial Information

A Phase II Study of 506U78 in Patients With Refractory or Relapsed T-Lineage Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphomas (LBL)


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.


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.

Inclusion Criteria


- 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


- 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


- No concurrent erythropoietin

- No other concurrent chemotherapy

- No concurrent dexamethasone or other steroidal antiemetics

- No concurrent hormone therapy, except for non-disease-related conditions

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Daniel DeAngelo, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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