Status:
UNKNOWN
Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Myeloid Leukemia in Remission
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysp...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the better of two treosulfan-based conditioning regimens in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), by comparing 6-month pro...
Eligibility Criteria
Inclusion
- MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia \[CMML\], and MDS/myeloproliferative neoplasm \[MPN\] unclassifiable syndromes)
- AML, other than acute promyelocytic leukemia (APL), in first or second remission or with minimal residual disease
- 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)
- Patients with previous autologous or allogeneic HCT are allowed to enroll
- DONOR: Human leukocyte antigen (HLA)-identical related donors or
- DONOR: Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for one HLA allele is allowed
- DONOR: Donors able to undergo peripheral blood stem cell collection or bone marrow harvest
- DONOR: Donors in good general health, with a Karnofsky or Lansky play performance score \> 90%
- DONOR: Donors able to give informed consent (if \> 18 years), or with a legal guardian capable of giving informed consent (if \< 18 years)
Exclusion
- Receiving umbilical cord blood
- With impaired cardiac function as evidenced by ejection fraction \< 35% (or, if unable to obtain ejection fraction, shortening fraction of \< 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease; patients with a shortening fraction \< 26% may be enrolled if approved by a cardiologist
- With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) \< 70 mm Hg and carbon monoxide diffusing capability test (DLCO) \< 70% of predicted or pO2 \< 80 mm Hg and DLCO \< 60% of predicted; (or, for pediatric patients unable to perform pulmonary function tests, then oxygen (O2) saturation \< 92% on room air), or receiving supplementary continuous oxygen
- With impaired renal function as evidenced by creatinine-clearance \< 50% for age, weight, height or serum creatinine \> 2 x upper limit of normal or dialysis-dependent
- With hepatic dysfunction as evidenced by total bilirubin \> 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
- With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) \> 2.0 x upper limit of normal 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
- With central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy, cranial irradiation or both prior to initiating conditioning (day -6)
- Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy
- With life expectancy severely limited by diseases other than malignancy
- Women who are pregnant or lactating
- With known hypersensitivity to treosulfan or fludarabine (fludarabine phosphate)
- 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
- DONOR: Individuals deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
- DONOR: Individuals who are HIV-positive
- DONOR: Individuals with active infectious hepatitis
- DONOR: Females with a positive pregnancy test
- DONOR: Persons 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 :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01894477
Start Date
November 1 2013
End Date
June 1 2022
Last Update
June 3 2021
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109