Clinical Trial VICCHEM1146
Ofatumumab in Combination with High Dose Cytarabine Chemoimmunotherapy for Patients with Newly Diagnosed Mantle Cell Lyjmphoma
- Protocol No. VICCHEM1146
- Open Date: 08/14/2012
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: To determine the overall response rate (ORR), and in particular, the complete remission rate (CRR) in previously untreated MCL treated with ofatumumab in combination with aggressive chemo-immunotherapy
- Disease Sites: Lymphoma
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Cyclophosphamide (CTX); Cytarabine (ARA-C); Dexamethasone; Doxorubicin; G-CSF; Leucovorin (Folinic acid); Mesna; Methotrexate; Ofatumumab; Vincristine
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01527149
- Secondary Protocol No: Not Specified
Patients with mantle cell lymphoma are invited to take part in this study. Compared to other kinds of lymphoma, mantle cell lymphoma is often difficult to get rid of permanently with the usual kinds of treatment such as rituximab plus chemotherapy and radiation therapy. Rituximab is a protein that was designed by genetic engineering. Rituxumab binds to CD20. CD20 is a protein that is in the surface of normal and cancerous B-cells, such as mantle cell lymphoma. When it binds to CD20, rituximab causes anti-cancer responses by activating the immune system to fight the cancer. It also weakens cancer cells by making chemotherapy drugs more powerful. Rituximab is used to treat mantle cell lymphomas, but some patients do not respond to rituximab. Some patients respond, but then the lymphoma returns over time. So it is important to develop new therapies. Ofatumumab is a new antibody used against CD20. In lab studies, ofatumumab appeared to be more powerful than rituximab. An antibody is a blood protein that fights disease cells like CD20. Ofatumumab has been approved by the US Food and Drug Administration (FDA) for treating chronic lymphocytic leukemia. This drug is being studied now for treating patients with B-cell lymphomas, including mantle cell lymphoma. In this study patients will receive the study drug, ofatumumab, in combination with alternating doses of high-dose chemotherapy. Patients will get the study drug and chemotherapy every 21 days, for 6 cycles. If they are eligible, study participants will also get an autologous stem cell transplant. Some patients have had good effects from a combination of high-dose chemotherapy and autologous stem cell transplantation after getting treatment with rituximab. Chemotherapy has been used to treat mantle cell lymphoma, and has been successful for many patients. Together, high-dose chemotherapy and autologous stem cell transplant (HDC-ASCT) is an intensive therapy and it can damage normal bone marrow. So this intensive treatment can lower blood cell counts by damaging bone marrow. For this reason, this treatment cannot be given to patients without a re-infusion of their own normal stem cells.
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