Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of California, Davis National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00619645 |
RATIONALE: Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Drug: busulfan Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Patients with recurrent disease or < 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 GVHD.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosed with any of the following:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
Chronic myelogenous leukemia (CML), meeting the following criteria:
First or second chronic phase
Chronic lymphocytic leukemia (CLL), meeting the following criteria:
Recurrent disease after fludarabine-based therapy
Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease*), or transformed NHL, meeting 1 of the following criteria:
Recurrent multiple myeloma, meeting the following criteria:
Myelodysplastic syndrome
Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:
PATIENT CHARACTERISTICS:
50 years of age or older
Patients 18-50 years of age are eligible if meeting 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
United States, California | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 |
Study Chair: | Carol M. Richman, MD | University of California, Davis |
Investigator: | Corinne Turrell, CCRP | University of California, Davis |
Responsible Party: | University of California Davis Cancer Center ( Carol M. Richman ) |
Study ID Numbers: | CDR0000583059, UCD-196, UCD-200715041 |
Study First Received: | February 20, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00619645 |
Health Authority: | Unspecified |
recurrent adult acute myeloid leukemia adult acute lymphoblastic leukemia in remission refractory anemia with excess blasts refractory anemia with ringed sideroblasts refractory anemia refractory cytopenia with multilineage dysplasia previously treated myelodysplastic syndromes adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia in remission adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
refractory chronic lymphocytic leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma recurrent adult acute lymphoblastic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma secondary acute myeloid leukemia recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma |
Cyclosporine Chronic myelogenous leukemia Refractory anemia Miconazole Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Anemia, Refractory Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Mycophenolate mofetil Neoplasm Metastasis |
Acute myeloid leukemia, adult Hodgkin Disease Myelodysplastic syndromes Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Multiple Myeloma Fludarabine Lymphoma, Non-Hodgkin |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Antifungal Agents Therapeutic Uses Syndrome Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |