Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of G… (NCT03192397) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
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
United States35 participantsStarted 2017-08-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 eje…
What they're measuring
1
Extensive Chronic Graft Versus Host Disease (GVHD)