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A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies

Phase 2
18 Years
Open (Enrolling)
Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Acute Lymphocytic Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma

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Trial Information

A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies

This is a clinical trial for subjects with hematologic malignancies ( acute myelogenous
leukemia, acute lymphocytic leukemia, Hodgkin's or Non-Hodgkin's lymphoma, or
myelodysplastic syndrome) who are in need of a donor stem cell transplant, and for whom an
umbilical cord blood transplant is thought to be the best option. For allogeneic transplant
donors, we typically try to use related family members, such as brothers or sisters, or
volunteer donors who are 'HLA matched', i.e. share similar proteins on their cells. This
study is for subjects for whom such a matched sibling donor or a matched unrelated donor is
not available.

This study tests a new method of bone marrow transplantation called combined haplo-identical
cord (haplo-cord) transplantation. In this procedure, cells from a related donor who shares
half of the HLA proteins ( haplo-identical)are collected from the blood, as well as cells
from an umbilical cord, and then both are transplanted. It is hoped that by using cells from
a haplo-identical relative, subjects will have a faster recovery and require fewer
transfusions. Over time the haplo-identical cells from the relative are replaced by the
cells from the cord blood. The combined transplantation of haplo-identical stem cells and
cord blood has previously been used in approximately 60 subjects with very encouraging

The purpose of this study is to compare the efficacy of haplo-cord transplant (
"investigational" arm) with the more commonly used procedure in which only the cells
contained in one or two umbilical cords are infused ("standard" arm). Subjects will be
randomly assigned into either the haplo-cord group or the umbilical cord group.

If randomized to the haplo-cord group, a family member will undergo a stem cell collection.
In both arms, subjects will receive a "conditioning regimen" prior to transplantation. The
conditioning regimen consists of chemotherapy, which is meant to destroy the cancer cells
and suppress the immune system to allow the transplanted cells to grow. Subjects will remain
in the hospital until the stem cells are fully recovered, which is usually 4 to 6 weeks
after the transplant. Subjects will have bone marrow aspiration and biopsy at 3 weeks, 4
weeks, 2 months, 6 months and 1 year after the transplant and then yearly thereafter.
Participation in the study will continue for up to 5 years after transplantation.

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

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

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. -

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of neutrophil engraftment after combined haplo-identical cord with that of umbilical cord blood transplantation.

Outcome Time Frame:

estimation of 24 months to determine engraftment rates for all subjects

Safety Issue:


Principal Investigator

Koen van Besien, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

October 2016

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Acute Lymphocytic Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Leukemia
  • Lymphoma
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms



Weill Cornell Medical College New York, New York  10021