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Spots Global Cancer Trial Database for Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma

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Trial Identification

Brief Title: Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma

Official Title: Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells

Study ID: NCT00006252

Study Description

Brief Summary: RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps 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. PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.

Detailed Description: OBJECTIVES: * Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation, in terms of 6-month treatment-related mortality, in patients with chronic lymphocytic leukemia, prolymphocytic leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma. * Determine the 6-month and 12-month probabilities of response in patients treated with this regimen. * Determine the time to disease progression in patients responding to this regimen. * Determine the percentage of donor chimerism achieved in patients treated with this regimen. * Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine the overall survival and disease-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3. Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover. Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120. Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive. Patients are followed every 3 months for 2 years and then every 6 months for 5 years. PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study.

Keywords

refractory chronic lymphocytic leukemia
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I adult diffuse small cleaved cell lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
prolymphocytic leukemia
stage I mantle cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
contiguous stage II small lymphocytic lymphoma
contiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

Veterans Affairs Medical Center - San Diego, San Diego, California, United States

UCSF Comprehensive Cancer Center, San Francisco, California, United States

Beebe Medical Center, Lewes, Delaware, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

St. Francis Hospital, Wilmington, Delaware, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States

Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, United States

UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Voorhees, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Elmhurst Hospital Center, Elmhurst, New York, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York, United States

Mount Sinai Medical Center, New York, New York, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States

Contact Details

Name: Thomas Shea, MD

Affiliation: UNC Lineberger Comprehensive Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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