Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.

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

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus; Vidarabine

Criteria

Inclusion Criteria:

• Diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant consistent with the standard of care

• Remission of any acute hematologic malignancy or adequate disease control for chronic malignancies.

• Ages 18-69 years old.

• Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor

Exclusion Criteria:

• Significant organ dysfunction defined as: LV EF < 50% (evaluated by echocardiogram or MRI), DLCO or FEV1 < 65% predicted, AST/ALT > 2.5 x ULN, Bilirubin > 1.5 x ULN, Serum creatinine > 2mg/dL, dialysis, or prior renal transplant

• HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation)

• Positive pregnancy test for women of childbearing age.

• Major anticipated illness or organ failure incompatible with survival form transplant.

• Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.