Status:
COMPLETED
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving treosulfan together with fludarabine phosphate and total-body irradiation followed by donor stem cell transplant works in treating patients with high-ri...
Detailed Description
PRIMARY OBJECTIVES: I. Decrease the incidence of relapse to \< 15% at 6 month post transplant in patients with high risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) transplanted f...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia (AML):
- All AML patients beyond 1st remission;
- Intermediate or high risk AML patients (based on South West Oncology Group \[SWOG\] cytogenetic criteria) in 1st complete remission
- Myelodysplastic syndrome (MDS)
- Other myeloid malignancies as chronic myelogenous leukemia (CML), CML accelerated phase, CML blast crisis, chronic myelomonocytic leukemia (CMML) (to be approved by patient care conference \[PCC\])
- With Karnofsky Index or Lansky Play-Performance Scale \> 70% on pre-transplant evaluation
- Able to give informed consent (if \> 18 years), or with a legal guardian capable of giving informed consent (if \< 18 years)
- Previous autologous or allogeneic HCT is allowed
- Donors must be:
- Human leukocyte antigen (HLA)-identical related donors or
- Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 defined by high resolution deoxyribonucleic acid (DNA) typing or mismatched for one HLA allele, except for HLA-C where no mismatch is allowed
- Able to undergo peripheral blood stem cell collection or bone marrow harvest
- In good general health, with a Karnofsky or Lansky Play Performance score \> 90%
- Able to give informed consent (if \> 18 years), or with a legal guardian capable of giving informed consent (if \< 18 years)
- Acute lymphoblastic leukemia (ALL): all ALL patients not eligible for other protocols
Exclusion
- Receiving umbilical cord blood
- With impaired cardiac function as evidenced by ejection fraction \< 35% or cardiac insufficiency requiring treatment or symptomatic coronary artery disease
- With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) \< 70 mm Hg and diffusing capacity of the lung for carbon monoxide (DLCO) \< 70% of predicted or pO2 \< 80 mm Hg and DLCO \< 60% of predicted; or receiving supplementary continuous oxygen
- With impaired renal function as evidenced by creatinine-clearance \< 50% for age, weight, height or serum creatinine \> 2x upper normal limit or dialysis-dependent
- With hepatic dysfunction as evidenced by total bilirubin or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.0 x upper normal limit or evidence of synthetic dysfunction or severe cirrhosis
- With active infectious disease requiring deferral of conditioning, as recommended by an Infectious Disease specialist
- With human immunodeficiency virus (HIV)-positivity or active infectious hepatitis because of possible risk of lethal infection when treated with immunosuppressive therapy
- With central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiating conditioning (day -6)
- With life expectancy severely limited by diseases other than malignancy
- Women who are pregnant or lactating because of possible risk to the fetus or infant
- With known hypersensitivity to treosulfan and/or fludarabine
- Receiving another experimental drug within 4 weeks before initiation of conditioning (day -6)
- Unable to give informed consent (if \> 18 years) or with a legal guardian (if \< 18 years) unable to give informed consent
- Ineligible donors will be those:
- Deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
- Who are HIV-positive
- With active infectious hepatitis
- Females with a positive pregnancy test
- Unable to give informed consent (if \> 18 years) or with a legal guardian (if \< 18 years) unable to give informed consent
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00860574
Start Date
February 1 2009
Last Update
June 22 2021
Active Locations (3)
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1
University of Colorado
Denver, Colorado, United States, 80217-3364
2
Oregon Health and Science University
Portland, Oregon, United States, 97239
3
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109