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

Alternate Title

Bone Marrow Transplant in Treating Patients With Hematologic Cancers

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	15 to 55	NCI	MCC-11281 MCC-IRB-4188, NCI-G00-1759, NCT00005797

Objectives

1. Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation (BMT).
2. Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body irradiation, and allogeneic BMT.
3. Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients.
4. Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diagnosis of:
  • Acute myelogenous leukemia
    • Complete remission (CR) 1 - ALL except good cytogenetics defined as [(inv16, t(8,21), t(15,17)]
    • CR2
    • Induction failures
    • Relapsed

    OR

  • Acute lymphocytic leukemia (ALL)
    • CR1 - high risk defined as overt CNS involvement, 1 or more risk factors (age 30 and over, WBC at least 20,000/mm³, at least 4 weeks to CR1, myeloid phenotype)
    • CR2
    • Induction failures
    • Relapsed

    OR

  • Chronic myelogenous leukemia
    • Chronic phase (CP) 1
    • Accelerated phase (AP)/CP2

    OR

  • Chronic lymphocytic leukemia
    • At diagnosis - RAI stage III/IV or Binet C
      • Must undergo 1 induction regimen
    • Relapsed - any stage
      • Must have received no more than 3 regimens for diagnosis

    OR

  • Multiple myeloma
    • At diagnosis - stage II/III (primary refractory or sensitive)
    • Relapsed no more than 2 times - sensitive disease
    • Plasma cell leukemia

    OR

  • Myelodysplasia
    • All subtypes eligible

    OR

  • Myeloproliferative disorders
    • Poor response to medical therapy

      OR

    • Cytogenetic abnormalities



• Must have a related donor who is genotypic 6 out of 6 HLA A, B, and DR match
  • Molecular DR matching required

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• 15 to 55

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• SGOT/SGPT no greater than 3 times upper limit of normal
• PT/PTT normal

Renal:

• Creatinine no greater than 2.0 mg/dL
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• LVEF at least 45% by MUGA scan or echocardiography
• No myocardial infarction within the past 6 months
• No arrhythmias controlled by therapy

Pulmonary:

• FEV₁ at least 50% predicted
• DLCO at least 50% predicted

Other:

• Not pregnant or nursing
• Negative pregnancy test
• No diabetes mellitus or thyroid disease that is not medically controlled
• No psychosocial disorder that would preclude study compliance
• No active serious infections
• HIV negative
• Donor must be HIV negative

Expected Enrollment

At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients with high risk myeloid disease will be accrued for this study.

Outcomes

Relapse-free survival
Overall survival
Treatment-related mortality
Toxicity

Outline

• Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT). Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic bone marrow is infused on day 0.



• Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI. Allogeneic bone marrow is infused on day 0.

Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis.

Patients are followed weekly for 3 months and then monthly for 1 year.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Teresa Field, MD, PhD, Protocol chair		Ph: 813-979-7202 ext. 8744; 888-663-3488

Registry Information
Official Title		Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: A Treatment Approach Based on Risk of Relapse and Toxicity
Trial Start Date		1996-06-06
Registered in ClinicalTrials.gov		NCT00005797
Date Submitted to PDQ		2000-01-12
Information Last Verified		2006-07-03
NCI Grant/Contract Number		CA76292

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