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Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas
This phase I/II trial studies the side effects and best dose of gemcitabine hydrochloride, clofarabine, and busulfan before donor stem cell transplant and to see how well it works in treating patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that does not respond to treatment. Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of 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.
PRIMARY OBJECTIVES: I. To define the maximum tolerated dose (MTD) of infusional gemcitabine (gemcitabine hydrochloride) combined with fixed doses of clofarabine and busulfan in patients with lymphoma receiving an allogeneic stem-cell transplant (alloSCT). II. To estimate the day +100 success rate, defined as percentage of patients who are alive, engrafted and without grade 3-4 graft-versus (vs.)-host-disease (GVHD). SECONDARY OBJECTIVES: I. To estimate the day +100 success rate (defined as percentage of patients who are alive, engrafted and without grade 3-4 graft-vs.-host-disease \[GVHD\]). II. To estimate the rate of event-free (EFS). III. To estimate the rate of overall survival (OS). IV. To estimate the response rate (RR) (defined as # of responses / # of patients with measurable tumors). V. To estimate the complete response (CR) rate (defined as # of complete responses / # of patients with measurable tumors). VI. To estimate the incidence of grade 2-4 and grade 3-4 acute GVHD. VII. To estimate the incidence of limited and extensive chronic GVHD. OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a phase II study. PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride intravenously (IV) over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with cluster of differentiation (CD)20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic bone marrow (BMT) or peripheral blood stem cell transplant (PBSCT) on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or orally (PO). Beginning on day 0, patients receive mycophenolate mofetil IV over 2 hours or PO thrice daily (TID). After completion of study treatment, patients are followed up at 3, 6, and 12 months, and then every 6 months for 4 years.
Age
12 - 65 years
Sex
ALL
Healthy Volunteers
Yes
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
October 25, 2012
Primary Completion Date
June 5, 2024
Completion Date
June 5, 2024
Last Updated
February 28, 2025
64
ACTUAL participants
Allogeneic Bone Marrow Transplantation
PROCEDURE
Allogeneic Hematopoietic Stem Cell Transplantation
PROCEDURE
Anti-Thymocyte Globulin
BIOLOGICAL
Busulfan
DRUG
Clofarabine
DRUG
Gemcitabine Hydrochloride
DRUG
Mycophenolate Mofetil
DRUG
Peripheral Blood Stem Cell Transplantation
PROCEDURE
Pharmacological Study
OTHER
Rituximab
BIOLOGICAL
Tacrolimus
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT06189391
NCT06484920
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00736749