Hematologic Malignancies Clinical Trial
Official title:
Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies
Patients with refractory hematologic malignancies including those who develop recurrent
disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal
prognosis. Historically, both regimen-related mortality and disease recurrence have been
significant causes of treatment failure in this heavily pre-treated patient population. The
investigators institution has utilized mismatched family member donors for these patients
for several reasons: (1) Only 30% of patients have matched related donors available; (2)
transplantation can be performed more rapidly since the time to unrelated donor
trans-plantation averages 3 to 4 months; (3) the alloimmune reactivity of natural killer
(NK) cells following haploidentical HSCT has been shown to reduce relapse rates in certain
patient groups; and, (4) no other curative treatment options are available.
In the present trial, the investigators propose a novel conditioning regimen using
clofarabine in an effort to enhance cytotoxicity while simultaneously reducing regimen
related toxicity. In this phase I trial, the goal is to determine the maximum tolerated dose
(MTD) of clofarabine when used in combination with melphalan and thiotepa pre-transplant.
The primary objective of this trial is to determine the maximum tolerated dose of
clofarabine in combination with thiotepa and melphalan as a conditioning regimen for a
haploidentical stem cell transplant with an engineered graft depleted of CD3+ cells. Study
participants will children and young adults with refractory hematologic malignancies.
Secondary objectives include the following:
- To describe the one-year overall survival (OS) and event-free survival (EFS) rates in
these study participants.
- To determine the time to hematopoietic recovery and donor cell engraftment following
this study treatment.
- To estimate the cumulative incidence of relapse in study participants.
- To estimate the incidence of overall grade II-IV and grade III-IV acute GVHD and the
rate of chronic GVHD.
- To estimate the incidence and describe the causes of non-hematologic regimen-related
toxicity and regimen-related mortality in the first 100 days post HSCT.
- To explore the biologic significance of soluble interleukin-2 (IL-2) receptor, tumor
necrosis factor (TNF), and lymphocyte reconstitution (qualitative and quantitative, V
beta spectratyping, TREC
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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