A Phase 2 interventional study of donor lymphocyte infusion in Donor Lymphocyte Infusion, Allogeneic Hematopoietic Stem Cell Transplantation and Acute Leukemia, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Prevention
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.
293 studies on the registry are indexed under Neoplasm, Residual; 137 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 198 interventional studies indexed under Neoplasm, Residual.
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Exclusion Criteria:
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.
Drug: donor lymphocyte infusion
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.
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.
Also known as: chemotherapy
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.
Time frame: one year
Number of participants who relapsed
Relapse was defined as recurrence of ≥5% bone marrow blasts or of ≥1 extra-medullary sites of leukaemia.
Time frame: one year
Number of surviving participants
The outcomes of participants are recored until one year
Time frame: one year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2017 (actual). Primary completion is estimated for Oct 2020, 43 months after the start.
Of 49 non-industry phase 2 interventional studies under Neoplasm, Residual, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 94. This study's planned 43 months is below that.
Counting every sponsor, half of 52 studies reached it within 71 months; a quarter within 50 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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