Status:
UNKNOWN
Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Donor Lymphocyte Infusion
Peripheral Blood Stem Cell Transplantation
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
Brief Summary
Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure fo...
Detailed Description
Conventional DLI has invariably been associated with high rates of severe graft-versus-host disease (GVHD) and GVHD-related non-relapse mortality (NRM). Thus, in our previous studies, the DLI procedur...
Eligibility Criteria
Inclusion
- disease in the non-remission (NR) state prior to transplantation, including primary induction failure, relapse untreated or refractory to reinduction chemotherapy.
- achieving CR1 with ≥3 cycles of induction of chemotherapy.
- carrying TP53, DNMT3a, TET2 or FLT3-ITD gene mutation.
Exclusion
- early relapse, either molecular relapse or hematological relapse.
- primary or secondary graft failure.
- concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure…).
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03771222
Start Date
January 1 2019
End Date
December 1 2021
Last Update
December 13 2018
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853