Combined Haploidentical-Cord Blood Transplantation for Adults and Children
This trial is active, not recruiting.
|Conditions||leukemia, myelodysplastic syndrome, multiple myeloma, lymphoma|
|Treatments||fludarabine-melphalan & rabbit antithymocyte globulin (r-atg), stem cell transplant, stem cells collections, fludarabine, thiotepa, antithymocyte globulin (atg), and total body irradiation (tbi), fludarabine, busulfan, and atg|
|Sponsor||University of Chicago|
|Start date||October 2006|
|End date||June 2016|
|Trial size||100 participants|
|Trial identifier||NCT00943800, 14736B|
The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acute and chronic graft-versus-host disease (GVHD).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To assess the rate of engraftment with combined haploidentical-cord blood
time frame: 60 days
To assess the rates of GVHD with combined haploidentical-cord blood (acute & chronic)
time frame: 1 year
Male or female participants at least 1 year old.
Inclusion Criteria: Patients will be eligible for this study if they have any one of the diseases that are known to be cured after allogeneic stem cell transplantation. 1. Relapsed or refractory acute leukemia (myeloid or lymphoid) 2. Acute leukemia in first remission at high-risk for recurrence 3. Chronic myelogenous leukemia in accelerated phase or blast-crisis 4. Chronic myelogenous leukemia in chronic phase 5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma 6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features 7. Multiple myeloma 8. Myelodysplastic syndrome 9. Chronic myeloproliferative disease 10. Hemoglobinopathies 11. Aplastic anemia Exclusion Criteria: 1. Zubrod performance status > 2 2. Life expectancy is severely limited by concomitant illness 3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's) 4. Estimated Creatinine Clearance <50 ml/min 5. Serum bilirubin> 2.0 mg/dl or SGPT >3 x upper limit of normal 6. Evidence of chronic active hepatitis or cirrhosis 7. HIV-positive 8. Patient is pregnant 9. Patient or guardian not able to sign informed consent
|Official title||Combined Haploidentical-Cord Blood Transplantation for Adults and Children|
|Principal investigator||Andrew Artz, M.D.|
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