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

Peking University

Status and phase: Unknown; Phase 2

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Acute Leukemia; Graft-versus-host Disease; Relapse; Donor Lymphocyte Infusion; Minimal Residual Disease

Treatments: Drug: donor lymphocyte infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03297528

PUPH2017-2-21

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

study group

Experimental group

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.

Treatment:

Drug: donor lymphocyte infusion

control group

No Intervention group

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.