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

Acute Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297528
• Other study ID #: PUPH2017-2-21
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2020
• Source: Peking University People's Hospital
• Contact: Chen-hua Yan, Dr
• Phone: 8610-82816999
• Email: yanchenhua[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Allogeneic Hematopoietic Stem Cell Transplantation
• Donor Lymphocyte Infusion
• Graft vs Host Disease
• Graft-versus-host Disease
• Leukemia
• Minimal Residual Disease
• Neoplasm, Residual
• Recurrence
• Relapse

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Institute of Hematology,Beijing	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	one year
Secondary	Number of participants who relapsed	Relapse was defined as recurrence of =5% bone marrow blasts or of =1 extra-medullary sites of leukaemia.	one year
Secondary	Number of surviving participants	The outcomes of participants are recored until one year	one year