CompletedPhase 2

A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL

United States27 participantsStarted 2014-06

Plain-language summary

This research study is evaluating a combination of drugs called Ofatumumab and Idelalisib as a possible treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL). The main purpose of this study is to examine the combination of the two drugs, Ofatumumab and Idelalisib, in participants who have been diagnosed with CLL/SLL and have not previously received treatment but do require treatment. The investigators hope to observe how participants' disease will be impacted by this treatment and whether they will benefit more from combining these drugs together rather than taking them separately. Both of these drugs have been used in treatment for CLL / SLL and information from those research studies suggests that these drugs may help patients with CLL/SLL. Ofatumumab is an antibody engineered in the lab against CD20, a protein on the surface of CLL cells, which is expressed in CLL. An antibody is a molecule your body creates to identify foreign substances so that it can destroy them. Ofatumumab has been FDA approved for treatment of CLL/SLL that has relapsed or progressed on other therapies. Idelalisib is a drug that blocks one of the signals inside the cells that cause this type of cancer to grow and survive. The investigators hope that combining Ofatumumab with Idelalisib will stop the growth of disease. In this research study, the investigators are evaluating the side effects of combining these two drugs, gathering information on the CLL/SLL disease process and how the study affects the patient's cells, as well as assessing the outcome of the disease. This combination of drugs has been previously tested, and appeared to be well tolerated.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Subjects must have CLL / SLL, as documented by a history at some point of an absolute peripheral blood B cell count \> 5000, with a monoclonal B cell population co-expressing CD19, CD5, and CD23, or if CD23 negative, then documentation of the absence of t(11;14) or cyclin D1 overexpression. Alternatively patients with lymphadenopathy in the absence of circulating disease will also be eligible for this study if lymph node biopsy establishes the diagnosis of CLL with the above immunophenotype. * Participants must have measurable disease (lymphocytosis \> 5,000, or palpable or CT measurable lymphadenopathy \> 1.5 cm, or bone marrow involvement \>30%). * Subjects must not have received any prior systemic therapy for CLL and currently have an indication for treatment as defined by the IWCLL 2008 Guidelines: * Massive or progressive splenomegaly; OR * Massive lymph nodes, nodal clusters, or progressive lymphadenopathy; OR * Grade 2 or 3 fatigue; OR * Fever ≥ 100.5°F or night sweats for greater than 2 weeks without documented infection; OR * Presence of weight loss ≥ 10% over the preceding 6 months; OR * Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period or an anticipated doubling time of less than 6 months; OR * Evidence of progressive marrow failure as manifested by the development of or worsening of anemia and or thromb…

What they're measuring

Overall Response Rate (ORR)

Timeframe: Disease evaluated on Cycle 2 day 22 (Restage end of cycle 2), Cycle 10 day 1 (Final Restage 2 months after end of ofa therapy) and off treatment prior to cycle 10. Treatment duration is median 243 days with range of 9-620 days.

Trial details

NCT IDNCT02135133

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-06

Results submitted2024-08-28