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Leukemia, Lymphoid

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Leukemia, Lymphocytic, Chronic, B-Cell

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Leukemia, B-Cell

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Chronic Graft Versus Host Disease

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Chronic Lymphocytic Leukemia

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Bendamustine Hydrochloride

Immunoglobulins

Ofatumumab

Antibodies, Monoclonal

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunologic Factors

Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.

ofatumumab + bendamustine

Mark Kirschbaum, MD

Jose Leis, MD

Investigational Drugs:

Ofatumumab (Azerra) + bendamustine (Trenda)

Route of Administration:

Intravenous (IV)

Hypothesis:

This study is designed to assess the toxicity and overall response rate. Ofatumumab is a fully human monoclonal antibody (A type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.

Participation:

Approximately 37 relapsed/refractory CLL subjects will participate in this study over two years.

Treatment Plan:

A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV 300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1 only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only.

Follow-up:

Patients will be followed monthly for six months, then every three months for five years then annually thereafter.

PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab

PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

The primary objective for this trial is to evaluate the overall response rate (CR+PR) of bendamustine and ofatumumab in patients with relapsed/refractory CLL.

The first secondary objective is to evaluate the toxicity of patients with relapsed/refractory CLL treated with bendamustine and ofatumumab.

Other secondary objectives include: evaluating the complete response rate, progression-free survivial, overal survival and time to next therapy

This study also aims to determine whether expression of of ZAP-70, CD38, IgVH status, and chromosomes, correlate with response rate, duration of response, and survival

Cephalon

GlaxoSmithKline

Nevada Cancer Institute

Lymphoma, Mantle-Cell

Lymphoma, Non-Hodgkin

Mantle Cell Lymphoma

Immunomodulating Agents

The proposed study is a Simon 2 stage optimal study design investigating the activity of ofatumumab alone or in conjunction with Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. The study design will allow for an estimation of the single agent response of ofatumumab in patients at low biologic risk for immediate disease progression.

The proposed study is a Simon 2 stage optimal study design investigating the activity of ofatumumab alone or in conjunction with Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. The combined regimen will assess the response rates of the combined chemo- immunotherapy program in patients with need for cytoreductive therapy, or high risk for disease progression. Patients with a leukemic phase only presentation of mantle cell lymphoma generally have clinically low-risk disease, regardless of mantle cell IPI calculations. Upon reciew with the principal investigator, these patients may be stratified to the immunotherapy only arm if clinically appropriate.

Ofatumumab Day 1 Week 1: 1000 mg, Day 2 week 1: 1000mg. Patients who exhibit a baseline leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose Ofatumumab Day 1, Weeks 2-4: 1000 mg Will reassess 8-10 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years

Ofatumumab (This arm is closed)

Ofatumumab day 1 + Bendamustine 90 mg/m2 days 1 \& 2 x 6 cycles q 28 days Cycle 1, day 1: Ofatumumab 1000 mg followed by Bendamustine 90 mg/m2. Patients who exhibit a leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose. Cycle 1, day 2: Ofatumumab 1000mg followed by Bendamustine 90 mg/m2 Cycles 2-6: Ofatumumab 1000 mg day 1, Bendamustine 90 mg/m2 days 1 and 2 Will reassess 4-6 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years

Ofatumumab + Bendamustine

Paul Hamlin, MD

This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of treatment are to control the lymphoma with the least amount of side effects. In many cases, MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced substance created to attach to proteins on the cancer cells, eventually destroying them. Chemotherapy is medicine that specifically destroys cancer cells.

The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab and Bendamustine have on this type of cancer. Patients in this study will either receive Ofatumumab alone, or Ofatumumab combined with Bendamustine.

Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant

of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)

in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks)

will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved.

(calculated from confirmation of CR to progression)will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR.

(calculated from confirmation of response (CR/PR) to progression. will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PH2 Trial in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab	NCT01131247	Chronic Lymphoc...	ofatumumab + be...	18 Years -	Nevada Cancer Institute
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant	NCT01437709	Mantle Cell Lym...	Ofatumumab (Thi... Ofatumumab + Be...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for ofatumumab + bendamustine