Fludarabine Phosphate Cyclophosphamide Total Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
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- STATUS
- Recruiting
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- End date
- Sep 6, 2023
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- participants needed
- 58
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- sponsor
- Roswell Park Cancer Institute
Summary
This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, 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. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem 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. The donated stem cells may also replace the patient?s immune cells and help destroy any remaining cancer cells.
Description
PRIMARY OBJECTIVES:
I. To evaluate the rate of relapse, defined as recurrence of underlying disease or progression of underlying disease, at 1 year in patients who receive haploidentical peripheral blood stem cells (PBSCs) after reduced intensity conditioning and post-transplant cyclophosphamide.
SECONDARY OBJECTIVES:
I. To evaluate safety including development of acute graft versus host disease (GVHD) and death at 100 days post-transplant, as well as other treatment related toxicities including chronic GVHD, engraftment rate, non-relapse mortality, progression free survival (PFS) at one year, and overall survival (OS) at one year, as compared with historical controls.
TERTIARY OBJECTIVES:
I. Correlative studies will include chimerism analysis by molecular analysis and evaluation of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry.
- OUTLINE
Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo total body irradiation (TBI) on days -1 and peripheral blood stem cell transplantation (PBSCT) on day 0.
After completion of study treatment, patients are followed up at 30 and 100 days.
Details
| Condition | Bone marrow disorder, Diamond-Blackfan anemia, childhood ALL, Wiskott-Aldrich Syndrome, Chronic myelomonocytic leukemia, Multiple Myeloma, Thalassemia, Juvenile Myelomonocytic Leukemia, Immunodeficiency, Preleukemia, Paroxysmal nocturnal hemoglobinuria, Thrombasthenia, Anemia, Aplastic Anemia, Waldenstrom's Macroglobulinemia, Acute myeloid leukemia, Thrombocytopathy, Myelosclerosis with myeloid metaplasia, Chronic granulomatous disease, Lymphoproliferative Disorder, Chronic Lymphocytic Leukemia, B-Cell Lymphoma, T-Cell Lymphoma, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, SICKLE CELL ANEMIA, chronic phase chronic myelogenous leukemia, Accelerated Phase Chronic Myelogenous Leukemia, Chronic myeloid leukemia, Polycythemia Vera, Platelet Deficiencies, Lymphocytic Leukemia, Chronic, Lymphoma, B-Cell, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Severe Aplastic Anemia, CD40 Ligand Deficiency, Refractory Non Hodgkin Lymphoma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Acute Leukemia in Remission, Acute Myeloid Leukemia With Gene Mutations, Myeloproliferative Neoplasms, Shwachman-Diamond Syndrome, Immune Deficiency, Anemia; Non-Small-Cell Lung Cancer, Primary Immunodeficiency Disorders, Lymphocytic Leukemia, Acute, Anemia; Non-Hodgkin’s Lymphoma, Hemoglobinuria, Paroxysmal, Acute Myeloid Leukemia With FLT3/ITD Mutation, Chronic Leukemia in Remission, Congenital Amegakaryocytic Thrombocytopenia, Congenital Neutropenia, Congenital Pure Red Cell Aplasia, Recurrent Non-Hodgkin Lymphoma, Shwachman-Diamond Syndrome, Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Non-Hodgkin Lymphoma, Shwachman-Diamond Syndrome, Shwachman Diamond Syndrome, Myelofibrosis, Platelet Disorders, Sickle Cell Disease, Lymphoproliferative disorders, Waldenstrom Macroglobulinemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Non-Hodgkin Lymphoma, Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Non-Hodgkin Lymphoma, Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Non-Hodgkin Lymphoma, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, immunodeficient, immunodeficiencies, decreased immune function, multiple myeloma (mm), myelodysplastic syndrome (mds), secondary aml, glanzmann's thrombasthenia, thromboasthenia, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, kostmann syndrome, kostmann's syndrome, kostmann, chronic myelomonocytic leukaemia, cmml, secondary mds, Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Non-Hodgkin Lymphoma |
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| Treatment | cyclophosphamide, fludarabine phosphate, laboratory biomarker analysis, peripheral blood stem cell transplantation, Total-Body Irradiation |
| Clinical Study Identifier | NCT03333486 |
| Sponsor | Roswell Park Cancer Institute |
| Last Modified on | 24 January 2021 |
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