Targeting the Inherited Paternal Antigen (IPA) and Matching for the Non-Inherited Maternal Antigen (NIMA) for Haplo-Cord Transplantation

Overview

In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant is a novel and promising way to improve transplant outcomes. We hypothesize that identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA) targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective recipient) is more important to the outcome of haplo cord transplant than the nucleated cell dose. The identification of such a graft for a large proportion of the subjects may necessitate accepting a lower umbilical cord graft dose.

In addition to a umbilical cord blood transplant, recipients will receive stem cells from a family member ( a haplo-identical donor) . After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device. The subject will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.

SparkCures ID 262
Trial Phase Phase 2
Enrollment 500 Patients
Treatments
Trial Sponsors
  • Weill Medical Medicine
NCT Identifier

NCT01810588

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Subject must have a confirmed diagnosis of:
    1. Previously Relapsed or refractory acute leukemia (myeloid or lymphoid)
    2. Acute leukemia in first remission at high-risk for recurrence
    3. Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis
    4. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
    5. Chronic lymphocytic leukemia, relapsed or with poor prognostic features
    6. Multiple myeloma
    7. Myelodysplastic syndrome
    8. Chronic myeloproliferative disease
    9. Hemoglobinopathies
    10. Aplastic anemia
    11. Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm)
  • Age ≥ 18 years
  • Likely to benefit from allogeneic transplant in the opinion of the transplant physician
  • An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.
  • Karnofsky (KPS) Performance status of >= 70%
  • Acceptable organ function as defined below: Serum bilirubin: < 2.0mg/dL ALT(SGPT): < 3 X upper limit of normal Creatinine Clearance: > 50 mL/min/1.73m2 (as estimated by the modified MDRD equation)
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Life expectancy is severely limited by concomitant illness or uncontrolled infection
  • Severely decreased Left Ventricular Ejection Fraction (LVEF) or impaired pulmonary function tests (PFT's)
  • Evidence of chronic active hepatitis or cirrhosis
  • Uncontrolled HIV disease
  • Pregnant or lactating

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Weill Cornell Medicine

New York, NY

Illinois
New York
Weill Cornell Medicine

New York, NY

Resources

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