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

Sponsor:	Robert H. Lurie Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004896

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed by bone marrow transplantation in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome.

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Drug: busulfan Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: bone marrow ablation with stem cell support Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclophosphamide Busulfan

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	October 1999
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004896

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Martin S. Tallman, MD

Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067575, NU-91H4T, NCI-G00-1686
Study First Received:	March 7, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004896 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Precancerous Conditions
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Pathologic Processes
Therapeutic Uses
Syndrome
Alkylating Agents
Neoplasms by Histologic Type

Disease
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Busulfan
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases

ClinicalTrials.gov processed this record on November 27, 2009