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

Alternate Title

Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 16 to physiologic 60 NCI NU-91H4T NCI-G00-1686, NCT00004896

Objectives

1. Determine the remission duration, disease-free survival, and overall survival of patients with acute myelogenous leukemia in remission or early relapse or myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation.

Entry Criteria

Disease Characteristics:

• Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) acute myelogenous leukemia or myelodysplastic syndrome of 1 of the following subtypes:
  • Acute myeloblastic leukemia (M1, M2)
  • Acute promyelocytic leukemia (M3)
  • Acute myelomonocytic leukemia (M4)
  • Acute monocytic leukemia (M5)
  • Acute erythroleukemia (M6)
  • Acute megakaryocytic leukemia (M7)
  • Refractory anemia
  • Refractory anemia with excess blasts
  • Refractory anemia with excess blasts in transformation
  • Refractory anemia with ringed sideroblasts
  • Chronic myelomonocytic leukemia



• In remission or in early relapse as defined by less than 20% blast cells in the marrow or overt active acute myeloid leukemia



• Suitable marrow donor, defined as a sibling donor matched at the HLA-A, HLA-B, and HLA-D/DR locus nonreactive in bidirectional mixed lymphocyte culture or a donor who is mismatched at 1 antigen loci



• Active CNS disease allowed

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent antibiotics

Patient Characteristics:

Age:

• 16 to physiologic 60

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 3 times upper limit of normal (ULN) unless due to Gilbert's disease
• SGOT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• Cardiac ejection fraction normal

Pulmonary:

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

Other:

• HIV negative
• No evidence of persistent infection
• No concurrent organ damage or medical problems that would preclude study therapy

Expected Enrollment

A total of 25-40 patients will be accrued for this study.

Outline

Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone marrow is infused on day 0.

Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow infusion on day 0.

All patients receive prophylaxis for graft versus host disease.

Patients are followed every 6 months for at least 2 years.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Martin Tallman, MD, Protocol chair		Ph: 312-695-0990

Registry Information
Official Title		Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients with Acute Myelogenous Leukemia
Trial Start Date		1999-10-28
Trial Completion Date		2004-08-17
Registered in ClinicalTrials.gov		NCT00004896
Date Submitted to PDQ		2000-01-12
Information Last Verified		2004-11-08
NCI Grant/Contract Number		CA60553

Back to Top