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A Prospective Study of Optimally Matched-IPA Targeted Haplo-cord Transplantation

Clinical Trial Details

This is a clinical trial for patients with hematologic malignancies (like leukemia, lymphoma, or myelodysplastic syndrome) who are in need of a donor stem cell transplant. Typically we try to use related family members, such as brothers or sisters, or a volunteer donor who is ‘HLA matched’ (shares similar proteins on their cells). However, sometimes we are unable to find a matched related or unrelated donor.

This study tests a new method of bone marrow transplantation called combined haplo-identical cord (haplo-cord) transplantation. A haplo-identical cord transplant is a type of transplant in which the patient receives the transplant stem cells from a relative (a haplo-donor) and cells from an unrelated umbilical cord. Before they are given to the patient, the cells from the haplo-identical donor will be treated using an investigational new device called the CliniMACS CD34 selection device.

The purpose of this study is to further improve the efficacy of the haplo-cord transplant program by choosing umbilical cord blood products that are the best match for a patient, rather than ones that have the highest number of cells. We hope to prove that better matching of the cord blood product will result in better long-term outcomes for patients undergoing haplo-cord transplant.

In the study, the patient’s family member (related donor) will undergo a stem cell collection. The patient will undergo a “conditioning regimen” prior to transplantation. The conditioning regimen consists of chemotherapy, which is meant to destroy the cancer cells and suppress the recipient’s immune system to allow the transplanted cells to grow. 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.

Patients will remain in the hospital until the stem cells are fully recovered, which is usually 4 to 6 weeks after the transplant. Patients 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. 

Key Eligibility: 
  • Age 18 or older
  • Diagnosed with:
    • Previously relapsed or refractory acute leukemia (myeloid or lymphoid)
    • Acute leukemia in first remission or high-risk for recurrence
    • Acute leukemia in first remission or high-risk for recurrence
    • Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis
    • Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
    • Chronic lymphocytic leukemia, relapsed
    • Multiple myeloma
    • Chronic myeloproliferative disease
    • Hemoglobinopathies
    • Aplastic anemia
  • Likely to benefit from allogeneic transplant and for whom an HLA-identical related or unrelated donor cannot be found
  • Detailed eligibility reviewed when you contact the study team

Contact

Jennifer Bourke, RN
jeb9097@med.cornell.edu
(212) 746-2844

Primary Investigator

Koen van Besien, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1205012383

Sponsor:

IIT NIMA

ClinicalTrials.gov:

NCT03393611

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Study Type