Combined Haploidentical-Cord Blood Transplantation for Adults and Children

The University of Chicago

Status: Completed

Conditions: Multiple Myeloma; Lymphoma; Myelodysplastic Syndrome; Leukemia

Treatments: Procedure: Stem Cell Transplant; Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG); Procedure: Stem Cells Collections; Drug: Fludarabine, Busulfan, and ATG; Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00943800

14736B

Details and patient eligibility

About

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).

Enrollment: 87 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Good Risks patients

Experimental group

Description:

For patients transplanted in remission.

Treatment:

Procedure: Stem Cell Transplant

Drug: Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)

Procedure: Stem Cells Collections

High Risk Patients eligible for radiation

Experimental group

Treatment:

Procedure: Stem Cell Transplant

Drug: Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)

Procedure: Stem Cells Collections

High Risk Patients not eligible for radiation

Experimental group

Treatment:

Drug: Fludarabine, Busulfan, and ATG

Procedure: Stem Cell Transplant

Procedure: Stem Cells Collections