- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662087
HMA+DLI vs DLI Preemptive Therapy Based on MRD for AL Undergoing Allo-HSCT
September 5, 2018 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University
Hypomethylating Agents + Donor Lymphocyte Infusion vs Donor Lymphocyte Infusion Preemptive Therapy Based on Minimal Residual Disease for Acute Leukemia Undergoing Allogenetic Hematopoietic Stem Cell Transplantation
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT.
Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy.
In this prospective randomized controlled study, the safety and efficacy of hypomethylating agents (HMA) + DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT.
Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy.
One method of solving relapse is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) .
DLI is an effective post-transplantation therapy based on MRD for relapse.
Whether combination of hypomethylating agents (HMA) and DLI could improve outcomes remains unclear.
In this prospective randomized controlled study, the safety and efficacy of HMA+DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hua Jin
- Phone Number: +86-020-61641613
- Email: 499509173@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Department of Hematology,Nanfang Hospital, Southern Medical University
-
Contact:
- Hua Jin
- Phone Number: +86-020-61641613
- Email: 499509173@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A patient age of 14-65 years. AL patients who achieved CR at pre-transplantation undergoing allo-HSCT. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
- AL patients who were in NR at pre-transplantation undergoing allo-HSCT. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure). Patients with any conditions not suitable for the trial (investigators' decision).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HMA+DLI
For AL patients who achieved CR at pre-transplantation undergoing allo-HSCT, DLI was not given and immunosuppressant were withdrawn if patients were MRD persistently negative.
MRD status were monitored every 30 days.
If patients were MRD negative by Day+30 post-transplantation, MRD status would be continued to be monitored by Day+60.
If patients were MRD positive by Day+30 post-transplantation, immunosuppressant were withdrawn.
If MRD were persistently positive until Day+60 or MRD changed from negative by Day+30 to positive by Day +60 post-transplantation, HMA and DLI were given.
DLI was given 48 hours after administration of HMA.
DLI was given monthly until GVHD occurred or MRD became negative or a total of four times.
If MRD changed from positive by Day+30 to negative by Day+60 post-transplantation, MRD status would be continued to be monitored by Day+90 post-transplantation.
If patients were MRD positive by Day+90 post-transplantation, HMA and DLI were given as shown above.
|
HMA: Decitabine was administered at 20mg/m2/day for five consecutive days or Ara-C was administered at 75mg/m2/day for seven consecutive days.
DLI was administered at a median dose of 1.0 (range 0.7-1.4)
×10*8 mononuclear cells/kg.
|
Experimental: DLI
For AL patients who achieved CR at pre-transplantation undergoing allo-HSCT, DLI was not given and immunosuppressant were withdrawn if patients were MRD persistently negative.
MRD status were monitored every 30 days.
If patients were MRD negative by Day+30 post-transplantation, MRD status would be continued to be monitored by Day+60 post-transplantation.
If patients were MRD positive by Day+30 post-transplantation, immunosuppressant were withdrawn.
If MRD were persistently positive until Day+60 or MRD changed from negative by Day+30 to positive by Day+60 post-transplantation, DLI was given.
DLI was given monthly until GVHD occurred or MRD became negative or a total of four times.
If MRD changed from positive by Day+30 to negative by Day+60 post-transplantation, MRD status would be continued to be monitored by Day+90 post-transplantation.
If patients were MRD positive by Day+90 post-transplantation, DLI was given as shown above.
|
DLI was administered at a median dose of 1.0 (range 0.7-1.4)
×10*8 mononuclear cells/kg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse
Time Frame: 2 years
|
Relapse was defined by reappearance of blasts in the peripheral blood, recurrence of BM blasts >5%, or development of extramedullary disease infiltrates at any site
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival (DFS)
Time Frame: 2 years
|
DFS was defined as the time from transplantation to relapse or death in remission
|
2 years
|
Overall survival (OS)
Time Frame: 2 years
|
OS was defined as the time from transplantation to death from all causes
|
2 years
|
Transplant-related mortality (TRM)
Time Frame: 2 years
|
TRM was defined as death from any cause except relapse
|
2 years
|
Incidence of acute GVHD
Time Frame: 100 days
|
Acute GVHD was graded according to standard criteria
|
100 days
|
Incidence of chronic GVHD
Time Frame: 2 years
|
Chronic GVHD was assessed in patients alive after day 100
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2018
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
September 5, 2018
First Submitted That Met QC Criteria
September 5, 2018
First Posted (Actual)
September 7, 2018
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMA+DLI vs DLI-MRD-AL-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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