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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00444912 |
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.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma Hodgkin's Disease |
Drug: AMD3100 (+G-CSF) Drug: AMD3100 (+G-CSF+Rituxan) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant |
Enrollment: | 30 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | September 2008 |
Arms | Assigned Interventions |
---|---|
Group A: Experimental | Drug: AMD3100 (+G-CSF) |
Group B: Experimental | Drug: AMD3100 (+G-CSF+Rituxan) |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | AMD31002113 |
Study First Received: | March 7, 2007 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00444912 |
Health Authority: | United States: Food and Drug Administration |
AMD3100 stem cell mobilization autologous transplant Non-Hodgkin's Lymphoma Hodgkin's Disease |
Lymphatic Diseases Hodgkin's disease Immunoproliferative Disorders Rituximab JM 3100 Hodgkin lymphoma, adult |
Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Anti-Retroviral Agents |
Immune System Diseases Therapeutic Uses Antiviral Agents Pharmacologic Actions |