Optimized CBT for Pts With High-risk Hematologic Malignancies Who Have Relapsed After First ASCT
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if intermediate-intensity conditioning therapy followed by a cord blood transplant can help to control high-risk hematological malignancies in patients who need a second allogeneic stem cell transplantation.
Description
Primary Objective: To evaluate 1-year overall survival (OS) following CBT with intermediate dose intensity conditioning for patients in need of a second allogeneic stem cell transplantation. Secondary Objectives: Speed and success of neutrophil and platelet engraftment. Incidences of graft failure. • Incidence of day 100 grade II-IV and III-IV aGVHD and day 180 grades II-IV and III-IV aGVHD. Incidence of 1-year, 2-year, and 3-year cGVHD. Incidence of TRM (100 days, 6 months, 1 and 2 years). The probabilities of relapse, OS, PFS, and GRFS at 1 year, 2, and 3 years as listed in the second…
Eligibility
- Age range
- Up to 60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient aged 0-60 y/o at the time of consent. Adult is defined as patients 18 years of age or older at the time of consent. 2. Patient must have relapsed \>100 days since first transplant. 3. Diagnosis and Disease Status: a. Acute myelogenous leukemia (AML): i. Patients in morphologic remission (\<5% blasts) at the time of transplant, with or without persistent cytogenetic, flow cytometric, or molecular aberrations, or those with hypocellular marrows at time of transplant, are eligible. b. Acute lymphoblastic leukemia (ALL): i. Patients in morphologic remission with…
Interventions
- DrugDrugs Cyclophosphamide
Given as standard of care treatment through IV infusion
- DrugFludarabine
Given as standard of care treatment through IV infusion
- DrugThiotepa
Given as standard of care treatment through IV infusion
- DrugTacrolimus
Given as standard of care treatment through IV infusion
- DrugMycophenolate mofetil
Given as standard of care treatment through IV infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas