Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia in Remission, Adult Acute Lymphoblastic Leukemia in Complete Remission, Chronic Myelogenous Leukemia, BCR-ABL1 Positive in Remission, Chronic Myelomonocytic Leukemia in Remission, Graft Versus Host Disease, Hodgkin Lymphoma, Minimal Residual Disease, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Severe Aplastic Anemia, Waldenstrom Macroglobulinemia

In brief

This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body irradiation 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

NCT03192397

Run by

Roswell Park Cancer Institute

People needed

35

Starts

2017-08-09

Expected to finish

2027-05-21

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have a diagnosis of one of the following (one must be yes):
• Acute myeloid leukemia (AML)
• Acute lymphoblastic leukemia (ALL)
• Chronic lymphoblastic leukemia (CLL)
• Chronic myelogenous leukemia (CML) (chronic phase intolerant or unresponsive to tyrosine kinase inhibitors, accelerated phase, history of blast crisis)
• Myelodysplastic syndrome (MDS)
• Non-Hodgkin lymphoma (NHL)
• Hodgkin lymphoma (HL) (received and failed frontline therapy or failed autologous transplantation or inability to collect enough peripheral blood stem cells [PBSC] for autologous hematopoietic cell transplant [auto-HCT])
• Multiple myeloma (MM)
• Severe aplastic anemia
• Histocompatible donor identified:
• Related donor matched 5/6 or better (A, B, DRB1)
• Unrelated donor matched 7/8 or better (A, B, C and DRB1)
• Patients with severe aplastic anemia do not have disease requirements; however, if the patient has a mismatched donor, the patient must have had prior therapy with ATG.
• The following are eligible for study inclusion:
• Patients with MDS/MPN only require <5% myeloblast on bone marrow evaluation.
• Patients with AML, ALL or CLL may be in CRi, patients with MM may be in VGPR
• Patients with NHL/HL must be in CR
• Have a Karnofsky performance status score of > 50%
• Diffusing capacity of the lung for carbon monoxide (DLCO) > 40% predicted, corrected for hemoglobin and/or alveolar ventilation
• Left ventricular ejection fraction > 40%
• Bilirubin =< 3 x upper limit of normal
• Liver alkaline phosphatase =< 3 x upper limit of normal
• Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit of normal
• Calculated creatinine clearance > 40 cc/min by the modified Cockroft-Gault formula

You may not qualify if…

• Moderate to severe myelofibrosis within 60 days prior to transplant
• Presence of human leukocyte antigen (HLA) antibodies to the donor within 60 days prior to transplant
• Patients who in the opinion of the treating physician are unlikely to comply with the restrictions of allogeneic stem cell transplantation based on formal psychosocial screening. (i.e., serious, uncontrolled psychiatric illness/social situations that would limit compliance with study requirements)
• Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient
• Known human immunodeficiency virus (HIV) positive
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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