At a glance
ClinicalIndex Comparison Record- ✓Hematologic malignancy with specified disease status: CLL (fludarabine-relapsed or non-CR post-salvage), Hodgkin/Non-Hodgkin lymphoma (primary failure, post-autologous SCT relapse, or hepatosplenic gamma/delta variant), Multiple Myeloma (primary failure, post-autologous SCT relapse, or non-CR post-salvage), AML (CR1 with high-risk cytogenetics or CR2+), ALL (CR1 with high-risk cytogenetics or CR2+), MDS (RAEB or RAEB-T with <10% blasts post-induction), myeloproliferative disorders, or CML in chronic/accelerated phase
- ✓Age 18-75 years (patients >75 years considered individually)
- ✓HLA-matched 6/6 first-degree relative donor
- ✓ECOG performance status 0 or 1
- ✕Active infection not responding to antimicrobial therapy
- ✕Active CNS involvement by malignancy
- ✕HIV infection
- ✕Chronic active hepatitis B (though hepatitis B core antibody positive with surface antigen negative is allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of EPOCH-F/R Induction Chemotherapy and Reduced-Intensity, HLA-Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation, With Cyclosporine & Methotrexate GVHD Prophylaxis for Refractory or Relapsed Hematologic Malignancies
In Brief
A Phase 2 clinical trial evaluating Stem cell transplantation, Fludarabine, and 8 other interventions for Hematologic Neoplasms. Completed, enrolled 62 participants across 1 site.
Detailed Summary
This study will investigate the safety and effectiveness of a modified stem cell transplant procedure for treating cancers of the blood and immune system. Patients with cancers and pre-cancerous conditions originating in blood or immune system cells can sometimes benefit greatly from, and even be cured by, transplants of stem cells (cells produced by the bone marrow that mature into blood cells). In addition to producing new bone marrow and restoring normal blood production and immunity, the donated cells fight any residual tumor cells that might have remained in the body, in what is called a graft-versus-tumor effect. However, severe problems, and sometimes death, may follow these transplants as a result of the high-dose chemotherapy and radiation that accompany the procedure. Also, donated immune system cells called T cells sometimes attack healthy tissues in a reaction called graft-versus-host-disease (GVHD), damaging organs such as the liver, intestines and skin. This study will use the following strategies to try to reduce these risks: * induction chemotherapy to reduce patient's immunity in an attempt to prevent rejection of the donated stem cells; * reduced-intensity conditioning chemotherapy that is easier for the body to tolerate and involves a shorter period of complete immune suppression; * donation of immune cells called T helper type 2 (Th2) cells instead of T cells to try to reduce the risk of serious GVHD; * treatment with methotrexate and cyclosporine to try to reduce the risk of serious GVHD. Patients between 12 and 75 years of age with non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia, acute lymphocytic leukemia, myelodysplasia, idiopathic myelofibrosis, polycythemia vera, or chronic myelomonocytic leukemia may be eligible for this study. Candidates will have a medical history, physical and dental examinations, blood and urine tests (including a blood test for genetic match with the donor), lung and heart function tests, and X-ray studies. A bone marrow biopsy may be done to evaluate disease status. Patients with lymphoma may have a nuclear medicine test called a positron emission tomography (PET) scan. Participants will have a central venous line (large plastic tube) placed into a major vein. This tube can stay in the body and be used during the entire treatment period to deliver the donated stem cells and give medications, including chemotherapy and other drugs, antibiotics and blood transfusions, and to withdraw blood samples. Treatment will start with induction chemotherapy, which will include the drugs fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. Some patients may also receive an antibody called rituximab. Patients will receive one to three cycles of this treatment, depending on their response to the drugs. (One cycle consists of 5 days on drug therapy followed by a 16-day rest period.) Several days before the transplant procedure, patients will start conditioning chemotherapy with cyclophosphamide and fludarabine. Three days after the conditioning therapy is completed, the stem cells will be infused. To help prevent GVHD, patients will take four doses of methotrexate (by vein) shortly after the transplant, and cyclosporine (by mouth or by vein) for about 6 months after the transplant. The average hospital stay for stem cell transplantation is 3 to 4 weeks. After discharge, patients will return for frequent follow-up visits for 3 months. Monthly visits will be scheduled for the next 3 months, then every 3 months for the next 18 months, and less frequently for a total of at least 5 years post-transplant. These visits will include bone marrow aspirates and biopsies, blood draws, and other tests to monitor disease status.
Study Details
Timeline
Interventions
Recipients will receive donor stem cells 3 days after conditioning therapy is completed.
Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
Recipients will receive induction therapy with fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. One cycle is 5 days on drug therapy followed by a 16 day rest period.
Recipients will receive 4 doses of methotrexate by vein after the transplant to help prevent graft-versus-host disease (GVHD)..
Recipients will receive cyclosporine by vein or by mouth for about 6 months after the transplant to help prevent graft-versus-host disease (GVHD).
Donors will undergo apheresis to collect stem cells for a stem cell transplant for the recipient.