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

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    40
  • sponsor
    Peking University People's Hospital
Updated on 23 January 2021
remission
graft versus host disease
acute leukemia
residual disease
leukemia
induction chemotherapy
minimal residual disease
donor lymphocyte infusion
chronic graft versus host disease

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.

Details
Condition Minimal Residual Disease, Relapse, Graft-Versus-Host Disease, Allogeneic Hematopoietic Stem Cell Transplantation, Recurrent Disease, Acute Leukemia, Donor Lymphocyte Infusion, Graft-Versus-Host Disease (GVHD), Allogeneic Hematopoietic Cell Transplantation, graft versus host disease, graft-versus-host-disease, relapsed disease, acute leukemias
Treatment Donor Lymphocyte Infusion
Clinical Study IdentifierNCT03297528
SponsorPeking University People's Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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