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

Phase 2

• Conditions: Donor Lymphocyte Infusion; Allogeneic Hematopoietic Stem Cell Transplantation; Relapse; Acute Leukemia; Graft-versus-host Disease; Minimal Residual Disease
• Interventions: Drug: donor lymphocyte infusion

• Registration Number: NCT03297528
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-21
• Study Start: 2017-03-01
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	donor lymphocyte infusion	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Institute of Hematology,Beijing; 🇨🇳 Beijing, Beijing, China