Cord Blood Transplantation for Patients With Cancer
- Conditions
- Hematological Disease
- Interventions
- Drug: Antithymocyte Globulin (ATG)Drug: Total Body Irradiation (TBI)
- Registration Number
- NCT01359254
- Lead Sponsor
- University of Chicago
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conditioning Regimen II Antithymocyte Globulin (ATG) Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Conditioning Regimen II Total Body Irradiation (TBI) Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Conditioning Regimen I Antithymocyte Globulin (ATG) Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Conditioning Regimen I Melphalan Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Conditioning Regimen I Fludarabine Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG) Conditioning Regimen II Fludarabine Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI). Conditioning Regimen II Busulfan Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
- Primary Outcome Measures
Name Time Method Cord Blood Engraftment by Day 100 100 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 Outcome Measures
Name Time Method Survival at Day 100 100 days Percent of subjects who are alive 100 days after the stem cell infusion
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States