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The Effect of Rituximab on Mobilization With AMD3100 Plus G-CSF in Patients With Relapsed or Refractory NHL or HD
Basic Trial Information
Summary Patients with NHL or HD will be assigned to one of 2 arms based on the immunophenotype of their lymphoma. (A)Patients with CD20(-) lymphoma will undergo mobilization with G-CSF and AMD3100. (B) Patients with CD20(+) lymphomas will undergo mobilization with Rituxan®, G-CSF, and AMD3100. They will receive a weekly dose of Rituxan® beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF. Patients in both groups will receive G-CSF twice daily for 4 days. In the evening on Day 4, a dose of AMD3100 will be administered. Apheresis will be initiated the next morning, Patients will continue to receive G-CSF twice daily and to receive the evening dose of AMD3100 followed by apheresis the next morning for up to a total of 4 aphereses or until ≧ 5 x 10e6 CD34+ cells/kg are collected. Patients who are transplanted will be monitored for the time to PMN, PLT, and lymphocyte engraftment. Follow-up assessments will be done at 100 days, and 6 and 12 months post-transplantation. Further Study Information This is a single-center, observational, 2-arm, non-randomized, open-label study to evaluate the safety of AMD3100 when used in combination with rituximab (Rituxan®) and granulocyte colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin's disease (HD) or non-Hodgkin's lymphoma (NHL). Patients will be assigned to one of 2 arms based on the immunophenotype of their lymphoma. (A)Patients with CD20(-) lymphoma will undergo mobilization with G-CSF and AMD3100. (B) Patients with CD20(+) lymphomas will undergo mobilization with Rituxan®, G-CSF, and AMD3100. They will receive a weekly dose of 375 mg/m2 Rituxan® by intravenous (iv) infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF. Patients in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening) for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of AMD3100 (240 µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10 to 11 hours after AMD3100 is given. Patients will continue to receive G-CSF twice daily and to receive the evening dose of AMD3100 followed by apheresis the next morning for up to a total of 4 aphereses or until ≧ 5 x 10e6 CD34+ cells/kg are collected. Patients with an adequate number of autologous peripheral blood stem cells (PBSCs) collected by apheresis will be admitted to the study center for the administration of high-dose chemotherapy and autologous transplantation. After transplantation, the times to PMN, PLT, and lymphocyte engraftment will be measured. Patients will remain hospitalized until they achieve an absolute granulocyte count of >500/µl in the peripheral blood. Graft durability will be assessed at 100 days, and 6 and 12 months post-transplantation. Eligibility Criteria Inclusion Criteria:
Exclusion Criteria:
Trial Lead Organizations/Sponsors Genzyme Corporation Link to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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