Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Historically, the best results of allogeneic SCT have been obtained when the stem cell donor is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for approximately 30 percent of patients in need for SCT. Alternative donor sources include matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic parents, biologic children and full or half siblings. There is strong body of evidence supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and favorable outcomes comparative to those seen using other allograft sources, including HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely manner especially for patients who need to proceed quickly to transplant due to concern of disease relapse/progression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Treatments: Cyclophosphamide; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Ages 16 years old and up

• Performance Status 70 percent or above

• Patients should have the following diseases:

• Acute myelogenous leukemia (AML)

• Acute lymphocytic leukemia or lymphoblastic lymphoma (ALL)

• Transfusion dependent myelodysplastic syndrome (MDS)

• Non-Hodgkin's Lymphoma (NHL)

• Chronic lymphocytic leukemia (CLL)

• Pulmonary function as measured by forced expiratory volume at one second (FEV1) and/or corrected diffusing capacity of lung for carbon monoxide (DLCO) at 60 percent of predicted or above

• Left ventricular ejection fraction at 45 percent or above

• If the donor-specific HLA antibodies (DSA) are positive, the patient must undergo a desensitization protocol resulting in undetectable DSA prior to day of transplant

Exclusion Criteria:

• Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except for hydroxyurea)

• Uncontrolled bacterial, fungal or viral infections at time of study enrollment

• Positive for HIV, human T-cell leukemia virus (HTLV-1) and/or Hepatitis C

• Subjects with signs/symptoms of active central nervous system (CNS) disease