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Clinical Trials (PDQ®)

  • Last Modified: 3/1/1995

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Clinical Trials (PDQ®)

Phase I Study of Autologous BMT with Anti-B4-bR-Treated Bone Marrow for Acute Lymphocytic Leukemia in Remission (Summary Last Modified 03/95)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentCompleted18 to 50DFCI-90039
NCI-V94-0579

Objectives

I.  Evaluate whether anti-B4-blocked ricin (anti-B4-bR) immunotoxin-treated 
autologous bone marrow can reconstitute hematologic and immunologic function 
after marrow ablative therapy.

II.  Compare hematologic engraftment of anti-B4-bR-treated bone marrow with 
previous results using bone marrow treated with anti-J5 (anti-CD10) and 
anti-J2 (anti-CD9) and complement.

III.  Compare hematologic engraftment of anti-B4-bR-treated autologous bone 
marrow with results using normal allogeneic T12-depleted bone marrow.

IV.  Evaluate overall and disease-free survival in patients receiving an 
anti-B4-bR-treated autologous bone marrow transplantation.

Entry Criteria

Disease Characteristics:


Histologically confirmed acute lymphocytic leukemia (ALL) in second or
subsequent complete remission
  Less than 5% blasts in bone marrow
  No blasts in peripheral blood

Significant reactivity of leukemic cells with anti-B4-bR at time of relapse
required

No HLA-compatible donor available for standard allogeneic transplant


Prior/Concurrent Therapy:


No greater than 3,000 cGy prior radiotherapy to the brain


Patient Characteristics:


Age:
  18 to 50

Performance status:
  Not specified

Hematopoietic:
  WBC greater than 3,000
  Platelets greater than 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl

Renal:
  Creatinine no greater than 1.6 mg/dl
  Creatinine clearance at least 50 ml/min

Cardiovascular:
  No uncompensated CHF

Other:
  No significant intercurrent infection
  No HIV positivity
  No pregnant women


Expected Enrollment

Up to 12 patients will be accrued; if marrow engraftment is substantially 
delayed in 3 of the first 6, 4 of the first 9, or 5 of the first 12 patients, 
accrual will cease.

Outline

The following acronyms are used:
  Anti-B4-bR   anti-B4-blocked-ricin immunotoxin, NSC-639185
  BMT          Bone Marrow Transplant
  CTX          Cyclophosphamide, NSC-26271
  TBI          Total-Body Irradiation

Single-Agent High-Dose Chemotherapy plus Radiotherapy followed by 
Hematopoietic Rescue.  HD CTX; plus TBI (equipment not specified); followed by 
autologous BMT.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Michael Robertson, MD, Protocol chair
Ph: 317-278-6942; 888-600-4822

Note: 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.

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