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

Completed · Phase 2

Conditions studied: Graft Versus Host Disease, Hematopoietic/Lymphoid Cancer

In brief

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.

Key facts

Study ID

NCT02248597

Run by

Wake Forest University Health Sciences

People needed

27

Starts

2015-02-25

Expected to finish

2023-01-18

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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