Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia
- Hodgkin's Disease
- Multiple Myeloma
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Non Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Younger than 70 years
- Gender
- Both males and females
Description
Study Design This is a prospective randomized trial to determine the effectiveness of different doses of GVHD prophylaxis on mucositis, engraftment and aGVHD. Study consists of two study groups of 50 subjects each. Group A will receive Tac and MTX (15 mg/m2 day +1, 10 mg/m2 day +3, +6, +11). Group B...
Study Design This is a prospective randomized trial to determine the effectiveness of different doses of GVHD prophylaxis on mucositis, engraftment and aGVHD. Study consists of two study groups of 50 subjects each. Group A will receive Tac and MTX (15 mg/m2 day +1, 10 mg/m2 day +3, +6, +11). Group B will receive Tac, Mini-dose MTX (5 mg/m2 on day +1, +3, +6) and MMF.
Tracking Information
- NCT #
- NCT01951885
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Betty Hamilton, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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