Primary Outcome Measures:
- To evaluate the safety of AMD3100 when used in combination with Rituxan® and G-CSF in patients with relapsed or refractory HD or NHL. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The number of CD34+ cells collected [ Time Frame: after apheresis period ] [ Designated as safety issue: No ]
- The increase in circulating CD34+ cells after AMD3100 administration [ Time Frame: after each dose of AMD3100 ] [ Designated as safety issue: No ]
- The number of apheresis days required to reach minimum of 3 x 10e6 CD34+ cells/kg [ Time Frame: after apheresis period ] [ Designated as safety issue: No ]
- PMN, PLT, and lymphocyte engraftment times [ Time Frame: transplant to engraftment ] [ Designated as safety issue: No ]
- The kinetics of lymphocyte, T-cell, B-cell, NK cell, and dendritic cell recovery post-transplant [ Time Frame: post transplant ] [ Designated as safety issue: No ]
- The content of B-cells in the grafts collected [ Time Frame: after each apheresis (from apheresis product) ] [ Designated as safety issue: No ]
- Durability of engraftment after autologous transplantation [ Time Frame: 3,6, and 12 months post transplant ] [ Designated as safety issue: No ]
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.