Overview

Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies

Status:
Terminated

Trial end date:
2015-04-29

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is compare the efficacy of haplo-cord transplant (investigational arm) with that of a more commonly used procedure in which only the cells contained in one or two umbilical cords are infused (standard arm). We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus host disease, low frequency of delayed opportunistic infections, reduced transfusion requirements, shortened length of hospital stay and promising long term outcomes. We also hypothesize that umbilical cord blood selection can prioritize matching and better matched donors can be identified rapidly for most subjects.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Weill Medical College of Cornell University

Treatments:

Fludarabine
Fludarabine phosphate
Melphalan
Thymoglobulin

Criteria

Inclusion Criteria:

1. Subject must have a histologically or cytologically confirmed diagnosis of: Acute
Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphocytic Leukemia Lymphoma
(Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma)

2. Must be > 18 years of age

3. Subject is likely to benefit from allogeneic transplant in the opinion of the
transplant physician

4. An human leukocyte antigen (HLA)-identical related or unrelated donor cannot be
identified within an appropriate time frame

5. Karnofsky Performance Status (KPS) of > 80

6. Subject has acceptable organ and marrow function as defined below: Serum bilirubin <
2.0mg/dL ALT(SGPT) 3 X upper limit of normal Creatinine Clearance > 50 mL/min as
estimated by the modified MDRD equation.18

7. Ability to understand and the willingness to sign a written informed consent document.

8. A preliminary search has identified both:

1. Appropriate umbilical cords for a single, or if necessary a double umbilical cord
blood (UCB) transplant AND

2. An appropriate single UCB as well as an appropriate haplo donor for haplo-cord
transplant

Exclusion Criteria:

1. Myeloproliferative disorders, hemoglobinopathies, severe aplastic anemia or any
diagnosis not listed under 3.1.1

2. Life expectancy is severely limited by concomitant illness or uncontrolled infection

3. Subjects with severely decreased Left Ventricular Ejection Fraction (LVEF) or impaired
pulmonary function tests (PFTs)

4. Subject has evidence of chronic active hepatitis or cirrhosis

5. Subject is HIV-positive

6. Subject is pregnant or lactating. -