Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- University of Chicago
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Cord Blood Engraftment by Day 100
Study Overview
Brief Summary
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
Detailed Description
Primary Objective
- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease
Secondary Objectives
- To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
- To describe the incidence and severity of acute and chronic GVHD.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Relapsed or refractory acute leukemia (myeloid or lymphoid)
- •Acute leukemia in first remission at high-risk for recurrence
- •Chronic myelogenous leukemia in accelerated phase or blast-crisis
- •Chronic myelogenous leukemia in chronic phase
- •Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
- •Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- •Multiple myeloma
- •Myelodysplastic syndrome
- •Chronic myeloproliferative disease
- •Hemoglobinopathies
- •Aplastic anemia
Exclusion Criteria
- •Zubrod performance status > 2
- •Life expectancy is severely limited by concomitant illness
- •Patients with severely decreased LVEF or impaired pulmonary function tests
- •Estimated Creatinine Clearance <50 ml/min
- •Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal
- •Evidence of chronic active hepatitis or cirrhosis
- •HIV-positive
- •Patient is pregnant
- •Patient or guardian not able to sign informed consent
Arms & Interventions
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Intervention: Antithymocyte Globulin (ATG) (Drug)
Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Intervention: Melphalan (Drug)
Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Intervention: Fludarabine (Drug)
Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Intervention: Antithymocyte Globulin (ATG) (Drug)
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Intervention: Fludarabine (Drug)
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Intervention: Busulfan (Drug)
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Intervention: Total Body Irradiation (TBI) (Drug)
Outcomes
Primary Outcomes
Cord Blood Engraftment by Day 100
Time Frame: 100 days
Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients. As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient.
Secondary Outcomes
- Survival at Day 100(100 days)