Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

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

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Obesity

Breast Diseases

Skin Diseases

Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group.

The control group will receive basic information on physical activity but not be instructed.

Exercise Regimen

Breanne Eddington

Karen Milligan, MD

The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.

Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.

Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory

The primary endpoint for this study change in C-reactive protein.

Compare changes in:

* Glucose
* Insulin
* Estradiol
* Testosterone

Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.

Quality of Life will be measured and compared between the groups

Comparing overall survival and progression free survival between groups.

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
Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory	NCT01157130	Early Stage Bre...	Exercise Regime...	18 Years -	Nevada Cancer Institute

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