Overview

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

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
For patients transplanted in remission.
fludarabine-melphalan & rabbit antithymocyte globulin (r-atg)
Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.
stem cell transplant
Infusion of haploidentical donor, umbilical cord blood
stem cells collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
(Experimental)
stem cell transplant
Infusion of haploidentical donor, umbilical cord blood
stem cells collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
fludarabine, thiotepa, antithymocyte globulin (atg), and total body irradiation (tbi)
Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
(Experimental)
stem cell transplant
Infusion of haploidentical donor, umbilical cord blood
stem cells collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
fludarabine, busulfan, and atg
Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.

Primary Outcomes

Measure
To assess the rate of engraftment with combined haploidentical-cord blood
time frame: 60 days

Secondary Outcomes

Measure
To assess the rates of GVHD with combined haploidentical-cord blood (acute & chronic)
time frame: 1 year

Eligibility Criteria

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

Additional Information

Official title Combined Haploidentical-Cord Blood Transplantation for Adults and Children
Principal investigator Andrew Artz, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Chicago.