Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant
Primary Purpose
Donor Lymphocyte Infusion, Allogeneic Hematopoietic Stem Cell Transplantation, Acute Leukemia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
donor lymphocyte infusion
Sponsored by
About this trial
This is an interventional prevention trial for Donor Lymphocyte Infusion
Eligibility Criteria
Inclusion Criteria:
- (1) acute leukemia in first complete or second complete remission;
- (2) relapse after an allotransplant;
- (3) had full or partial donor chimerism;
- (4) received re-induction chemotherapy and DLI and achieved a negative MRD-test.
Exclusion Criteria:
- (1) active GvHD
- (2) active infection
- (3) organ dysfunction
Sites / Locations
- Peking University Institute of Hematology,BeijingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
Participants receive chemotherapy and donor lymphocyte infusions based on the state GvHD, even the participants have a negative result of minimal residual disease (MRD). If the participants have no GvHD,they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD.
Participants don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD,in dispite of whether or not GvHD.
Outcomes
Primary Outcome Measures
Number of participants with a positive results of minimal residual disease that is evaluated by testing aberrant leukemia-associated immune phenotypes and WT1 mRNA levels.
Investigators use two strategies to test for minimal residual disease in bone marrow samples: (1) aberrant leukemia-associated immune phenotypes detected by 4 colour flow cytometry; and (2) WT1 mRNA levels detected by polymerase chain reaction.
Secondary Outcome Measures
Number of participants who relapsed
Relapse was defined as recurrence of ≥5% bone marrow blasts or of ≥1 extra-medullary sites of leukaemia.
Number of surviving participants
The outcomes of participants are recored until one year
Full Information
NCT ID
NCT03297528
First Posted
February 21, 2017
Last Updated
March 9, 2020
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03297528
Brief Title
Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant
Official Title
Multiple Consolidation Chemotherapy and DLI Prevent Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant and Achieving Complete Remission After Induction Chemotherapy and DLI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia interventions are at high-risk of a second relapse. Previous studies from investigators reported an association between a positive minimal residual disease (MRD)-test after transplant and an increased risk of subsequent relapse. Also, patients developing chronic graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia relapse after a first allotransplant have a lower likelihood of a second relapse compared with similar patients not developing chronic GvHD. And, our previous study also reported patients with chronic GvHD after DLI was associated with a greater frequency of a negative MRD-test and lower likelihood of subsequent relapse compared with similar persons not developing chronic GvHD. Based on these data the investigators designed a randomized control study to determine whether giving additional consolidation chemotherapy and DLI might decrease likelihood of second relapse in persons without chronic GvHD or with a positive MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Donor Lymphocyte Infusion, Allogeneic Hematopoietic Stem Cell Transplantation, Acute Leukemia, Minimal Residual Disease, Graft-versus-host Disease, Relapse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Participants receive chemotherapy and donor lymphocyte infusions based on the state GvHD, even the participants have a negative result of minimal residual disease (MRD). If the participants have no GvHD,they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD,in dispite of whether or not GvHD.
Intervention Type
Drug
Intervention Name(s)
donor lymphocyte infusion
Other Intervention Name(s)
chemotherapy
Intervention Description
Participants in study group receive chemotherapy and donor lymphocyte infusion based on the state of GvHD, even they have a negative result of MRD. If participants in study group have no GvHD, they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD. If the participants in study group have GvHD, they will be observed. But, the participants in control group don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD, in despite of whether or not GvHD.
Primary Outcome Measure Information:
Title
Number of participants with a positive results of minimal residual disease that is evaluated by testing aberrant leukemia-associated immune phenotypes and WT1 mRNA levels.
Description
Investigators use two strategies to test for minimal residual disease in bone marrow samples: (1) aberrant leukemia-associated immune phenotypes detected by 4 colour flow cytometry; and (2) WT1 mRNA levels detected by polymerase chain reaction.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Number of participants who relapsed
Description
Relapse was defined as recurrence of ≥5% bone marrow blasts or of ≥1 extra-medullary sites of leukaemia.
Time Frame
one year
Title
Number of surviving participants
Description
The outcomes of participants are recored until one year
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) acute leukemia in first complete or second complete remission;
(2) relapse after an allotransplant;
(3) had full or partial donor chimerism;
(4) received re-induction chemotherapy and DLI and achieved a negative MRD-test.
Exclusion Criteria:
(1) active GvHD
(2) active infection
(3) organ dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-hua Yan, Dr
Phone
8610-82816999
Email
yanchenhua@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, Dr
Phone
8610-82816999
Email
ywyw3172@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-jun Huang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Institute of Hematology,Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-hua Yan
Email
yanchenhua@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Xiao-Jun Huang, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant
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