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Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies

Phase 2
19 Years
55 Years
Open (Enrolling)
Leukemia, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies

OBJECTIVES: I. Determine the 1-year survival rate of patients with hematologic malignancies
after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose

OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide
IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on
days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0.
Methylprednisolone is administered IV over 1 hour on days 5-16, and then tapered. Patients
are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia
(CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts
(RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1
(CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia
(ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after
induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No
HLA-matched, sibling donor for BMT available No current CNS disease No history of more
than 2 episodes of active CNS disease

PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL
Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active
congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within
the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if
received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g.,
mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant
Fertile patients must use effective contraception No concurrent debilitating medical or
psychiatric illness that would preclude compliance No prior malignancy except curatively
treated skin cancer or carcinoma of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior
autologous or allogeneic bone marrow transplantation No prior transfusions from donor
Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul V. O'Donnell, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • refractory multiple myeloma
  • chronic phase chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • acute undifferentiated leukemia
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia



Johns Hopkins Oncology Center Baltimore, Maryland  21287
Center for Cancer Treatment and Research Columbia, South Carolina  29203