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

NCT03297528 — Phase 2, Unknown, 40 participants, Peking University People's Hospital
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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

RegistryNCT03297528
StatusUnknown
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment40 (Estimated)
SponsorPeking University People's Hospital (Other)
ConditionsDonor Lymphocyte Infusion, Allogeneic Hematopoietic Stem Cell Transplantation, Acute Leukemia, Minimal Residual Disease, Graft-versus-host Disease, Relapse
Interventionsdonor lymphocyte infusion (Drug)
Datesstart 2017-03-01, primary completion 2020-10-01 (estimated), completion 2021-10-01 (estimated), first posted 2017-09-29, last updated 2020-03-10
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
study groupExperimentalDrug: donor lymphocyte infusionParticipants 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.
control groupNo interventionParticipants 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.
  • donor lymphocyte infusion (Drug), also known as chemotherapy: 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.
  • Number of surviving participants [one year]: The outcomes of participants are recored until one year

+Eligibility

Sex: All, ages: 5 Years to 60 Years

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

+Locations (1)

FacilityCityCountryStatus
Peking University Institute of Hematology,BeijingBeijing, Beijing MunicipalityChinaRecruiting

+Investigators

My Notes