Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer

  • STATUS
    Not Recruiting
  • End date
    Sep 6, 2023
  • participants needed
    58
  • sponsor
    Roswell Park Cancer Institute
Updated on 10 October 2022
cancer
immunosuppressant
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
anemia
blood stem cell transplant
imatinib
cyclophosphamide
chronic lymphocytic leukemia
immunodeficiency
tyrosine
chromosomal abnormalities
lymphoma
myelofibrosis
myelodysplastic syndromes
multiple myeloma
anti-thymocyte globulin
hodgkin's disease
acute leukemia
myelodysplasia
immunosuppressive
white blood cell count
chronic myelomonocytic leukemia
calcineurin inhibitor
carbon monoxide
ejection fraction
waldenstrom's macroglobulinemia
secondary aml
cell transplantation
leukemia
x-rays
bone marrow procedure
lymphocytic leukemia
transplant conditioning
reduced intensity conditioning
antithymocyte globulin
thrombocytopenia
autologous transplant
autologous transplantation
secondary acute myeloid leukemia
cytotoxic chemotherapy
schwartz
white blood cells
progressive disease
chemotherapy regimen
chromosome abnormalities
autograft
wbc count
cancer chemotherapy
immunosuppressants
myelomonocytic leukemia
b-cell lymphoma
immunoglobulin
conditioning regimen
immune disorder
aplastic anemia
pancytopenia
diamond-blackfan anemia
kostmann syndrome
neutropenia
splenectomy
immune globulin
blood cell count
hemoglobinopathy
bone marrow failure
chromosomal abnormality
sickle cell anemia
kostmann's syndrome
wiskott-aldrich syndrome
lymphoproliferative disease
polycythemia vera
thalassemia
glanzmann's thrombasthenia
secondary myelodysplastic syndrome
shwachman-diamond syndrome
bone marrow failure syndromes
thrombasthenia
chronic granulomatous disease
chromosome abnormality
bone marrow failure disorders
lymphocyte immune globulin
eculizumab
severe combined immunodeficiency
cytotoxic therapy
polycythemia
flt3-itd
cytogenetic abnormalities
congenital neutropenia
b cell lymphoma

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 and tocilizumab (or tocilizumab alternative).

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 Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Aplastic Anemia, B-Cell Non-Hodgkin Lymphoma, CD40 Ligand Deficiency, Chronic Granulomatous Disease, Chronic Leukemia in Remission, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Congenital Amegakaryocytic Thrombocytopenia, Congenital Neutropenia, Congenital Pure Red Cell Aplasia, Glanzmann Thrombasthenia, Immunodeficiency Syndrome, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Paroxysmal Nocturnal Hemoglobinuria, Plasma Cell Myeloma, Polycythemia Vera, Recurrent Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Severe Aplastic Anemia, Shwachman-Diamond Syndrome, Sickle Cell Disease, T-Cell Non-Hodgkin Lymphoma, Thalassemia, Waldenstrom Macroglobulinemia, Wiskott-Aldrich Syndrome
Treatment cyclophosphamide, fludarabine phosphate, laboratory biomarker analysis, peripheral blood stem cell transplantation, Total-Body Irradiation
Clinical Study IdentifierNCT03333486
SponsorRoswell Park Cancer Institute
Last Modified on10 October 2022

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cancer
immunosuppressant
chronic myeloid leukemia
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total body irradiation
fludarabine
hematologic malignancy
anemia
blood stem cell transplant
imatinib
cyclophosphamide
chronic lymphocytic leukemia
immunodeficiency
tyrosine
chromosomal abnormalities
lymphoma
myelofibrosis
myelodysplastic syndromes
multiple myeloma
anti-thymocyte globulin
hodgkin's disease
acute leukemia
myelodysplasia
immunosuppressive
white blood cell count
chronic myelomonocytic leukemia
calcineurin inhibitor
carbon monoxide
ejection fraction
waldenstrom's macroglobulinemia
secondary aml
cell transplantation
leukemia
x-rays
bone marrow procedure
lymphocytic leukemia
transplant conditioning
reduced intensity conditioning
antithymocyte globulin
thrombocytopenia
autologous transplant
autologous transplantation
secondary acute myeloid leukemia
cytotoxic chemotherapy
schwartz
white blood cells
progressive disease
chemotherapy regimen
chromosome abnormalities
autograft
wbc count
cancer chemotherapy
immunosuppressants
myelomonocytic leukemia
b-cell lymphoma
immunoglobulin
conditioning regimen
immune disorder
aplastic anemia
pancytopenia
diamond-blackfan anemia
kostmann syndrome
neutropenia
splenectomy
immune globulin
blood cell count
hemoglobinopathy
bone marrow failure
chromosomal abnormality
sickle cell anemia
kostmann's syndrome
wiskott-aldrich syndrome
lymphoproliferative disease
polycythemia vera
thalassemia
glanzmann's thrombasthenia
secondary myelodysplastic syndrome
shwachman-diamond syndrome
bone marrow failure syndromes
thrombasthenia
chronic granulomatous disease
chromosome abnormality
bone marrow failure disorders
lymphocyte immune globulin
eculizumab
severe combined immunodeficiency
cytotoxic therapy
polycythemia
flt3-itd
cytogenetic abnormalities
congenital neutropenia
b cell lymphoma

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