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

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.

Conditions

• 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

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSCT

RADIATION

Total-Body Irradiation

Undergo TBI

Sponsors & Collaborators

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Philip McCarthy, MD · Roswell Park Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-07

Primary Completion

2023-08-28

Completion

2023-08-28

FDA Drug

Yes

Countries

• United States

Study Locations