Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

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

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Lenalidomide

Ofatumumab

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

* Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
* Treatment to be administered for up to 6 cycles

* Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
* Treatment to be administered for up to 6 cycles

-Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

The purpose of this research is to evaluate the safety and effectiveness of the drugs lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).

Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Phase 2 Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).

Overall response rate was defined as those who experienced a response of CR, CRi or PR.

Frequency of adverse and severe adverse events

Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.

Number of adverse events occuring in greater than 20% of subjects

Number of dose reductions due to toxicity.

GlaxoSmithKline

Celgene Corporation

Medical University of South Carolina

All subjects enrolled on study were evaluated for toxicity.

Oratumumab and Lenalidomide

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Clinical Trials Network Manager

Overall response rate is defined as response (CR, CRi or PR) at cycle 3 or cycle 6 evaluation. Only patients who completed at least 3 cycles were eligible for analysis for this outcome measure.

Overall Response Rate

Number of SAEs

Neutropenia

grade 3/4 neutropenia

thrombocytopenia

grade 3/4 thrombocytopenia

tumor flare reaction

grade 3 tumor flare reaction

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

* Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
* Treatment to be administered for up to 6 cycles

Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)

-Treatment to be administered for up to 6 cycles

Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.

Frequency of Adverse and Severe Adverse Events

The biomarker sub-study was not completed due to poor accrual to this substudy and lack of feasibility.

Spots Global Cancer Trial Database for Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial