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

Alternate Title

Prevention of Side Effects in Patients With Leukemia Undergoing a Second Bone Marrow Transplant

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Closed 11 to 50 NCI FHCRC-176.05 NCI-H94-0375

Objectives

I.  Assess whether granulocyte-macrophage colony stimulating factor and 
pentoxifylline reduce the incidence and severity of posttransplant mortality 
and morbidity from granulocytopenia and veno-occlusive disease in patients 
with lymphoid or myeloid malignancies undergoing a second marrow transplant 
with marrow from the same allogeneic (T-depleted marrow) or syngeneic donor 
following relapse from an initial transplant regimen that included total-body 
irradiation.

Entry Criteria

Disease Characteristics:

Lymphoid or myeloid malignancy that has relapsed after an allogeneic or
syngeneic bone marrow transplantation regimen that included total-body
irradiation
  No chronic phase chronic lymphocytic leukemia initially treated on protocol
  FHCRC-612

  No T-cell disease

  No interleukin-2 receptor expression

No documented bone marrow graft rejection
  At least 6 months since initial transplantation

Original allogeneic or syngeneic donor available who is:
  Psychologically, physiologically, and medically able to tolerate the
     procedure a second time
  Free of increased anesthetic risk from a pre-existing illness
  HIV seronegative

Prior/Concurrent Therapy:

See Disease Characteristics

Patient Characteristics:

Age:
  11 to 50 

Performance status:
  Not specified

Life expectancy:
  No severe limitation other than the leukemia

Other:
  No pulmonary, cardiac, hepatic, or renal impairment that would
     contraindicate therapy
  Not HIV seropositive

Patients eligible for this protocol are potentially eligible for companion
protocol FHCRC-618 (posttransplant interleukin-2)

Expected Enrollment

Approximately 60 patients will be entered over 3 years.  If the incidence of 
VOD or the day 50 mortality rate increases significantly compared to 
historical controls, accrual may stop early.

Outline

Patients with myeloid malignancies are treated on Regimen A; those with 
lymphoid malignancies are treated on Regimen B.  The following acronyms are 
used:
  ABM     Allogeneic Bone Marrow
  BCNU    Carmustine, NSC-409962
  BU      Busulfan, NSC-750
  CTX     Cyclophosphamide, NSC-26271
  GM-CSF  Granulocyte-Macrophage Colony Stimulating Factor (Immunex),
          NSC-613795
  MTX     Methotrexate, NSC-740
  PTX     Pentoxifylline
  SBM     Syngeneic Bone Marrow
  VOD     Veno-occlusive Disease
  VP-16   Etoposide, NSC-141540

REGIMEN A:  2-Drug Marrow-Ablative Chemotherapy plus Single-Agent Intrathecal 
Chemotherapy with VOD Prophylaxis followed by Hematopoietic Rescue.  BU; CTX; 
plus IT MTX; with PTX; followed by ABM/SBM; GM-CSF.

REGIMEN B:  3-Drug Marrow-Ablative Chemotherapy plus Single-Agent Intrathecal 
Chemotherapy with VOD Prophylaxis followed by Hematopoietic Rescue.  VP-16; 
BCNU; CTX; plus IT MTX; with PTX; followed by ABM/SBM; GM-CSF.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Jerry Radich, MD, Protocol chair		Ph: 206-667-4118 Email: jradich@fhcrc.org