Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk Lymphoid Malignancies
This phase I/II trial studies the side effects and the best dose of radiolabeled monoclonal antibody when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with high-risk lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium Y 90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving chemotherapy before a stem transplant stops the growth of cancer cells by stopping them from dividing or killing them. Stem cells collected from the patient's blood are then returned to the patient to replace the blood-forming cells that were destroyed by the radiolabeled monoclonal antibody and chemotherapy.
PRIMARY OBJECTIVES:
I. To estimate the maximum-tolerated dose (MTD) of 90Y-BC8-DOTA (yttrium Y 90 anti-CD45
monoclonal antibody BC8) (anti-cluster of differentiation [CD] 45) that can be delivered
prior to myeloablative carmustine, etoposide, cytarabine, and melphalan (BEAM) chemotherapy
and autologous stem cell transplant (ASCT) for patients with high-risk B-non-Hodgkin lymphoma
(NHL), T-NHL, and Hodgkin lymphoma (HL).
II. To evaluate the efficacy of 90Y-BC8-DOTA when administered at the estimated MTD prior to
BEAM chemotherapy and ASCT for patients with high-risk B-NHL, T-NHL, and HL compared to
historical controls treated with BEAM alone.
SECONDARY OBJECTIVES:
I. To describe the toxicity observed from the addition of 90Y-BC8-DOTA to BEAM.
II. To optimize the protein dose (Ab) to deliver a favorable biodistribution in the majority
of patients.
III. To describe response rates and overall survival of patients with high-risk B-NHL, T-NHL,
and HL following administration of 90Y-BC8-DOTA plus BEAM prior to ASCT.
IV. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden
on CD45 targeting.
V. To assess the correlation of lymphoma biomarkers with outcomes.
VI. To evaluate the effects of nodal-targeted irradiation by 90Y-BC8-DOTA on immune
reconstitution following ASCT.
OUTLINE: This is a phase I, dose-escalation study of yttrium Y 90 anti-CD45 monoclonal
antibody BC8 followed by a phase II study.
Patients receive yttrium Y 90 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day
-14. Patients also receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours
twice daily (BID) on days -6 to -3, cytarabine IV over 4 hours BID on days -6 to -3, and
melphalan IV over 30 minutes on day -2. Patients then undergo autologous peripheral blood
stem cell (PBSC) transplant on day 0.
After completion of study treatment, patients are followed up at 3, 6, and 12 months and then
annually thereafter.
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