Oncology Research Program

Highlights of the NCCN Oncology Research Program

The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.

NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.

NCCN-sponsored studies funded through the grant mechanism are highlighted below.

Ofatumumab (O) in Combination With Chemotherapy: Hyperfractionated Cyclophosphamide, Doxorubicin, Vincristine, and Dexamethasone (O-HyperCVAD) Alternating With Ofatumumab High-Dose Cytarabine and Methotrexate (O-MA) for Patients With Newly Diagnosed Mantle Cell Lymphoma

Principal Investigator: Francisco Hernandez-Ilizaliturri, MD

Condition: Mantle cell lymphoma

Institution: Roswell Park Cancer Institute

This phase II trial studies how well ofatumumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and dexamethasone alternating with ofatumumab in combination with high-dose cytarabine and methotrexate (HD-MA) works in treating patients with newly diagnosed mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways: they can block the ability of cancer to grow and spread, and can help the immune system kill cancer cells. Other monoclonal antibodies find cancer cells and help kill them or carry cancer-killing substances or radioisotopes to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone, cytarabine, and methotrexate, work in different ways to stop the growth of cancer cells by either killing the cells or stopping them from dividing. Giving ofatumumab together with alternating regimens of combination chemotherapy may kill more cancer cells.

A maximum of 37 patients at 2 sites (Roswell Park Cancer Institute and Vanderbilt-Ingram Cancer Center) will be enrolled. It is expected that patients will be receiving treatment on this study for approximately 6 months, after which eligible patients will receive an autologous stem cell transplant (ASCT).

Primary Objective:

  • 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 chemoimmunotherapy

Secondary Objectives:

  • Determine the high-sensitivity flow cytometry CRR for previously untreated MCL treated with ofatumumab in combination with aggressive chemoimmunotherapy +/- high-dose chemotherapy and ASCT (HDC-ASCT)

  • Determine the time-to-progression (TTP), progression-free survival (PFS), and overall survival (OS) of patients with previously untreated MCL treated with ofatumumab and aggressive chemoimmunotherapy +/- HDC-ASCT

  • Determine the toxicity profiles of ofatumumab in combination with high-dose cytarabine chemoimmunotherapy +/- HDC-ASCT

  • Correlate minimal residual disease (MRD) at different intervals with TTP, PFS, and OS

  • Correlate surface CD20 levels, Ki67, and additional cytogenetic abnormalities in pretreatment tumor biopsies with respect to ORR, CRR, TTP, PFS, and OS

  • Determine the relationship between proliferation signature and clinical outcome using quantitative real-time reverse-transcriptase polymerase chain reaction

  • Determine changes in surface CD20 levels, Ki67 levels, or gain of additional cytogenetic abnormalities in relapsed/refractory tumor specimens

  • Correlate serum C3, C4, and CH50 levels measured at baseline and at the end of first ofatumumab infusion with ORR, CRR, MRD, TTP, PFS, and OS

  • Evaluate the ability of the induction and consolidation therapy to get 70% of patients to ASCT

  • Evaluate the tolerability and CD34+ cell yield after therapy with hyperfractionated cyclophosphamide, doxorubicin, vincristine, and dexamethasone (HyperCVAD)/HD-MA

  • Compare differences in response rates in patients with MCL treated with ofatumumab + HyperCVAD/HD-MA according to criteria reported by Cheson et al and the revised Cheson criteria

Contact: Roswell Park • 877-275-7724 • AskRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01527149

The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.

For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.

For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at NCCN.org/clinical_trials/clinicians.asp.

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