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Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia


Phase 2
16 Years
60 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia


OBJECTIVES:

- 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.

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.

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

Inclusion 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

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:

- FEV_1 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No concurrent antibiotics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Martin S. Tallman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 91H4T

NCT ID:

NCT00004896

Start Date:

October 1999

Completion Date:

August 2004

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute promyelocytic leukemia (M3)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute megakaryoblastic leukemia (M7)
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • adult acute monocytic leukemia (M5b)
  • previously treated myelodysplastic syndromes
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • atypical chronic myeloid leukemia
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611