Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Antilymphocyte Serum; Fludarabine; Fludarabine phosphate; Melphalan; Mycophenolic Acid; Rituximab; Tacrolimus; Thymoglobulin; Vidarabine

Criteria

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