Combined Haploidentical-Cord Blood Transplantation for Adults and Children

Not Applicable

Completed

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

Brief 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).

Recruitment & Eligibility

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.

Exclusion Criteria

Zubrod performance status > 2
Life expectancy is severely limited by concomitant illness
Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)
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

Arm && Interventions

Group	Intervention	Description
High Risk Patients eligible for radiation	Stem Cells Collections	-
Good Risks patients	Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)	For patients transplanted in remission.
High Risk Patients eligible for radiation	Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)	-
Good Risks patients	Stem Cells Collections	For patients transplanted in remission.
High Risk Patients eligible for radiation	Stem Cell Transplant	-
High Risk Patients not eligible for radiation	Stem Cell Transplant	-
Good Risks patients	Stem Cell Transplant	For patients transplanted in remission.
High Risk Patients not eligible for radiation	Stem Cells Collections	-
High Risk Patients not eligible for radiation	Fludarabine, Busulfan, and ATG	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Neutrophil Engraftment	Transplant (Day 0) through Day +28	Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC \<500/mm3 and platelet count \< 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity \< 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to \< 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)	Up to 2 years	Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al) The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported
Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years	up to 5 years	We reported overall survival at 2 years and 5 years after transplant