Status:
COMPLETED
Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
medac GmbH
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giv...
Detailed Description
OBJECTIVES: Primary Phase * Determine the best dose of treosulfan when administered with fludarabine as a reduced-intensity conditioning regimen followed by allogeneic hematopoietic stem cell transp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia, lymphoblastic leukemia, or myelodysplastic syndrome
- Any phase allowed, including any of the following:
- Disease in remission
- Relapsed or primary refractory disease
- No CNS leukemic involvement not clearing with prior intrathecal chemotherapy and/or cranial radiotherapy
- Planning to undergo unmanipulated allogeneic bone marrow or peripheral blood stem cell transplantation
- Filgrastim (G-CSF) mobilization of bone marrow or stem cells allowed
- Donor available, meeting 1 of the following criteria:
- HLA-identical related donor
- HLA-A, -B, -C, -DRB1, and -DQB1 matched unrelated donor by high-resolution DNA typing
- A single allele mismatch allowed
- PATIENT CHARACTERISTICS:
- Performance status
- Karnofsky 70-100% OR
- Lansky 70-100%
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST ≤ 2 times ULN
- No evidence of synthetic dysfunction
- No severe cirrhosis
- No active infectious hepatitis
- Renal
- Creatinine clearance ≥ 50%
- Creatinine ≤ 2 times ULN
- Dialysis independent
- Cardiovascular
- No cardiac insufficiency requiring treatment
- No symptomatic coronary artery disease
- Ejection fraction ≥ 35% (for patients with history of cardiac disease or anthracycline exposure)
- Pulmonary
- PO\_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR
- PO\_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
- Not requiring supplementary continuous oxygen
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other disease that would severely limit life expectancy
- No HIV positivity
- No active infection requiring deferral of conditioning
- No known hypersensitivity to the study drugs
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- No prior allogeneic bone marrow or stem cell transplantation
- No concurrent umbilical cord blood or autologous transplantation
- Chemotherapy
- See Disease Characteristics
- Radiotherapy
- See Disease Characteristics
- Other
- More than 4 weeks since prior experimental drugs
- Concurrent enrollment on another protocol for graft-versus-host disease prophylaxis allowed
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00253513
Start Date
June 1 2005
End Date
October 1 2009
Last Update
June 1 2012
Active Locations (3)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
2
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
3
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109