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Sponsored by: |
Genzyme |
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00396331 |
Patients who would benefit from an autologous stem cell transplant, who have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests and who meet the inclusion/exclusion criteria are eligible to enter this study. Once 70 patients have enrolled, subsequent patients enrolled must have a diagnosis of lymphoma.
The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 on the evening prior to each day of apheresis.
Patients will undergo mobilization with G-CSF. On the 4th Day, AMD3100 will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter. Patients will continue to receive G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until ≥2 x 10e6 CD34+ cells/kg are collected, whichever occurs first.
If enough cells are collected the patient will be treated with high-dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF with AMD3100 mobilization regimen.
Condition | Intervention | Phase |
Autologous Stem Cell Transplantation |
Drug: AMD3100 Procedure: Stem Cell Mobilization |
Phase II |
MedlinePlus related topics: | Lymphoma |
Drug Information available for: | Granulocyte colony-stimulating factor JM 3100 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Poor Mobilizing Adult Patients Who Have Previously Failed Stem Cell Collection/Attempts |
Estimated Enrollment: | 100 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | August 2009 |
This is a Phase 2, multicenter, prospective, observational, open-label study. Once 70 patients have enrolled, subsequent patients enrolled must have a diagnosis of lymphoma. Patients who would benefit from an autologous stem cell transplant, who have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines, chemotherapy and cytokines and bone marrow harvests and who meet the inclusion/exclusion criteria are eligible to receive AMD3100 as outlined in this protocol. The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 on the evening prior to each day of apheresis.
Patients will undergo mobilization with G-CSF (10 µg/kg) for 4 days. On Day 4, AMD3100 (240 µg/kg) will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until ≥2 x 10e6 CD34+ cells/kg are collected, whichever occurs first. In addition, the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of AMD3100 will be examined.
After the last apheresis has been completed, or after the patient has collected ≥2 x 10e6 CD34+ cells/kg, he/she will be treated with high-dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF with AMD3100 mobilization regimen. In the event that the minimum number of ≥2 x 10e6 cells for transplantation are not obtained from the first mobilization with AMD3100, cells may be retained and pooled for transplantation with those from a second mobilization with AMD3100, at the investigator's discretion. If a second mobilization with AMD3100 is attempted, a minimum rest interval of one week should be allowed between the last apheresis of the first regimen and the first dose of G-CSF of the second. The number of CD34+ cells mobilized in the peripheral blood (PB),collected in the apheresis product, and the number of apheresis sessions performed will be measured. Success of the transplantation will be evaluated.
Ages Eligible for Study: | 18 Years to 78 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | MedInfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | MedInfo@genzyme.com |
United States, California | |||||
City of Hope National Medical Center` | Recruiting | ||||
Duarte, California, United States, 91010 | |||||
Contact: Nigel Cheng 626-359-8111 ext 62968 | |||||
Principal Investigator: Auayporn Nademanee, MD | |||||
United States, Florida | |||||
H. Lee Moffitt Cancer Center | Recruiting | ||||
Tampa, Florida, United States, 33612-9497 | |||||
Contact: Dawn Garrett 813-745-7227 garretdl@moffitt.usf.edu | |||||
Principal Investigator: Lia E Perez, MD | |||||
United States, Georgia | |||||
Blood & Marrow Transplant Group of Georgia | Recruiting | ||||
Atlanta, Georgia, United States, 30342 | |||||
Contact: Melanie Hawkins 404-255-1930 ext 1190 Melanie.Hawkins@Northside.com | |||||
Principal Investigator: Scott Solomon, MD | |||||
United States, Michigan | |||||
University of Michigan Comprehensive Cancer Center | Recruiting | ||||
Ann Arbor, Michigan, United States, 48109-0473 | |||||
Contact: Nancy McCullough 734-936-8538 | |||||
Principal Investigator: Shin Mineishi, MD | |||||
United States, Mississippi | |||||
University of Mississippi Medical Center, Div of Hematology | Recruiting | ||||
Jackson, Mississippi, United States, 39216 | |||||
Contact: Dana Delasky 601-984-5615 | |||||
Principal Investigator: Stephanie Elkins, MD | |||||
United States, Missouri | |||||
Kansas City Cancer Centers | Recruiting | ||||
Kansas City, Missouri, United States, 64111 | |||||
Contact: Shaun DeJarnette 816-960-6069 shaun.dejarnette@usoncology.com | |||||
Principal Investigator: Joseph McGuirk, MD | |||||
United States, New Jersey | |||||
Hackensack University Medical Center | Recruiting | ||||
Hackensack, New Jersey, United States, 07601 | |||||
Contact: Angelica Panganiban 201-996-5843 | |||||
Principal Investigator: Scott Rowley, MD | |||||
United States, Virginia | |||||
Virginia Commonwealth University - Massey Cancer Center | Recruiting | ||||
Richmond, Virginia, United States, 23298-0037 | |||||
Contact: Cathy Roberts 804-828-1292 | |||||
United States, Wisconsin | |||||
University of Wisconsin, Blood and Bone Marrow Transplant | Recruiting | ||||
Madison, Wisconsin, United States, 53792-5156 | |||||
Contact: Teri Mitchell 608-263-8629 | |||||
Principal Investigator: Peiman Hematti, MD |
Genzyme |
Principal Investigator: | John McCarty, MD | Virginia Commonwealth University |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | AMD31002112 |
First Received: | November 2, 2006 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00396331 |
Health Authority: | United States: Food and Drug Administration |
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