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Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant

Sponsor
Peking University People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03297528
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
55
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: donor lymphocyte infusion
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group

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.

Drug: donor lymphocyte infusion
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.
Other Names:
  • chemotherapy

    		•
    No Intervention: control group

    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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. [one year]

      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

    1. Number of participants who relapsed [one year]

      Relapse was defined as recurrence of ≥5% bone marrow blasts or of ≥1 extra-medullary sites of leukaemia.

    2. Number of surviving participants [one year]

      The outcomes of participants are recored until one year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Institute of Hematology,Beijing Beijing Beijing China 100044

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Study Director: Xiao-jun Huang, Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaojun Huang,MD, Professor, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03297528
    Other Study ID Numbers:
    • PUPH2017-2-21
    First Posted:
    Sep 29, 2017
    Last Update Posted:
    Mar 10, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Neoplasm, Residual
    Graft vs Host Disease
    Recurrence
    Acute Disease

    Study Results

    No Results Posted as of Mar 10, 2020