Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial
Official title:
A Prospective Study Evaluating the Efficacy of the Allogeneic Hematopoietic Cell Transplantation With Antithymocyte Globulin (ATG)-Based Conditioning of Adult Acute Lymphoblastic Leukemia in First / Second Complete Hematologic Remission
This study is a prospective multicenter observational study to evaluate the feasibility and the efficacy of the conditioning regimens which are modified by the donor differences and the age of recipients among patients who will receive allogeneic hematopoietic stem cell transplantation in their 1st or 2nd hematologic complete remission (CR).
Allogeneic hematopoietic cell transplantation (AlloHCT) is recommended as a post-remission
therapy for patients with adult ALL, and reduced intensity conditioning has been tried to
decrease treatment-related mortality (TRM) rate.
Recent results showed that reduced intensity conditioning can be safely and effectively used
for alloHCT of adult patients with ALL. However, the reduced intensity conditioning (RIC) can
increase the possibilities of hematologic relapse, especially due to the reduced
anti-leukemic effect. Another challenge in performing alloHCT for ALL is the donor
availability - the limited availability of matched sibling donor (MSD) and well-matched
unrelated donor (WMUD) forces us to find the feasibility of alternative donors such as
partially-matched unrelated donor (PMUD) or haploidentical familial donor (familial
mismatched donor, FMD).
The previous study (NCT0137764) which the investigators performed showed that the use of RIC
and alternative donor was feasible. However, the incidence of relapse was slightly higher
among patients who received RIC when the investigators analyzed the interim analysis results.
Especially, the graft-versus-host disease (GVHD) incidence was relatively higher among
patients who received alloHCT from MSD, and the investigators think that the addition of
antithymocyte globulin will reduce the incidence of GVHD for these patients.
In this study, the dose of busulfan will be increased when the recipients are below 55 years
old, irrespective of donor type. The investigators will also define the partially matched
donor exactly and find the feasibility of PMUD and FMD again. Another endpoint for this study
is to find out whether the addition of antithymocyte globulin may be helpful in preventing
the GVHD incidence for patients who received alloHCT from MSD without increasing the chance
of hematologic relapse.
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