Status:
COMPLETED
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop t...
Detailed Description
OBJECTIVES: Primary * To determine the incidence and severity of acute graft-versus-host disease (GVHD) after HLA-matched or -mismatched unrelated donor peripheral blood stem cell transplantation (P...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of a hematological malignancy, including any of the following:
- Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)
- Hodgkin lymphoma in CR or PR
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either of the following criteria:
- In CR
- Not in CR and meets the following criteria:
- Bone marrow blast \< 20% within 4 weeks of transplantation
- Peripheral blood absolute blast count \< 500 per microliter on the day of initiating conditioning therapy
- Myelodysplastic syndromes, treated or untreated
- Chronic myeloid leukemia in chronic phase or accelerated phase
- Multiple myeloma in CR or PR
- Chronic lymphocytic leukemia in second or greater CR or PR
- Myelofibrosis or other myeloproliferative disorders meeting the following criteria:
- Bone marrow blasts \< 20% within 4 weeks of transplantation
- Peripheral blood absolute blast count \< 500 per microliter on the day of initiating conditioning therapy
- Patients with ascites not allowed
- No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+ enrichment, T-cell depletion, etc)
- Scheduled to undergo peripheral blood stem cell transplantation from a suitable HLA-matched or -mismatched unrelated donor, as determined by treating physician
- High resolution molecular HLA typing is required for HLA class I and II
- No more than one antigen or allele mismatch
- No documented uncontrolled CNS disease
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2
- Karnofsky PS 60-100%
- Creatinine clearance \> 50 mL/min
- Bilirubin \< 3 times upper limit of normal (ULN)
- ALT and AST \< 3 times ULN
- LVEF \> 50%
- FVC, FEV\_1, or DLCO \> 50% predicted
- Patients on home oxygen not allowed
- Able to cooperate with oral medication intake
- HIV negative
- No active hepatitis B or hepatitis C
- No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00691015
Start Date
May 1 2008
End Date
April 1 2014
Last Update
June 28 2017
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379