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

Chronic Lymphocytic Leukemia Clinical Trial

Official title: A Phase II Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Before the research starts (screening): After signing the consent form, the participant will be asked to undergo some screening tests or procedures to find out if they are eligible to be in this research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.

• A medical history, which includes questions about the participant's health, current medications, and any allergies.

• Physical examination, which includes vital signs, height, weight, and disease assessment by the size of the participant's spleen, liver, and lymph nodes.

• Performance status, which evaluates how the participant is able to carry on with their usual activities.

• An assessment of the patient's tumor by CT (Computerized Tomography) scan, MRI or PET (Positron Emission Tomography) scans,

• Bone marrow aspirate and biopsy: A study tube (plastic cylinder container that contains biopsy material) will be drawn during this biopsy to further assess the participant's disease status.

• Blood tests, a maximum of 24 teaspoons will be collected.

• Urine test.

• A blood pregnancy test

• A Hepatitis B and C test, will require blood sample.

If these tests show that the participant is eligible to participate in the research study, then the participant will be begin will begin the study treatment. If you do not meet the eligibility criteria, the participant will not be able to participate in this research study.

Additional research procedures to be performed at the time of screening:

• Blood tests, including baseline tests so that the investigators can measure any additional effect of the study drug and disease status

After the screening procedures confirm that you are eligible to participate in the research study:

If you take part in this research study, the participant will be given a study drug-dosing diary for each treatment cycle. Each treatment cycle lasts 28 days. The diary will also include special instructions for taking the study drugs.

• Study Drugs: The participant will first be given Idelalisib daily for two cycles of 28 days each. Idelalisib will be given orally. Once the participant completes 2 cycles of Idelalisib, then the participant will start to receive a combination of Ofatumumab and Idelalisib. This regimen will continue weekly to complete 8 weeks (two more cycles). This will be followed by monthly Ofatumumab and Idelalisib to complete 4 additional cycles (eight total). The overall treatment period will therefore be 8 months, comprised of two months of Idelalisib followed by 6 months of Ofatumumab with Idelalisib. After completing the 8-month treatment, the participant will likely continue Idelalisib. Restaging with CT scans will happen after Cycle 2, 4, and a final restage will occur 2 months after the completion of Ofatumumab. There will be a tumor response assessment done during a physical exam after Cycle 8.

• Clinical Exams: During all cycles the participant will have a physical exam and will be asked questions about their general health and specific questions about any problems that they might be having and any medications they may be taking.

• Scans (or Imaging tests): The investigator will assess the participant's tumor by CT scan. Restaging with CT scans will happen after Cycle 2, 4, and a final restage will occur 2 months after the completion of Ofatumumab.

• Bone marrow aspirate and biopsy: will be conducted to see if the bone marrow has tumor cells. A study tube will be drawn during this biopsy to further assess the patient's disease status

• Blood tests

Additional Blood Tests:

Blood Tests will be performed throughout the study so that the Investigator can measure any additional effect of the study drug and disease status. These tests will be taken on the days listed below before the participant receive study drug, on some days additional blood will be drawn after they receive study drug.

Cycle 3 Day 1 Cycle 3 Day 8 Cycle 3 Day 15 Cycle 4 Day 21 (last weekly Ofatumumab dose) Cycle 5 Day 1 (first monthly Ofatumumab dose) Cycle 8 Day 1 (last monthly Ofatumumab dose) 2 months after Ofatumumab therapy completed 6 months after Ofatumumab therapy completed

Planned Follow-up:

Once the participant has completed the study treatment, the participant will be monitored until they start a new type of treatment or are removed from the study. During this time the participant will meet with your research physician every 3 or 6 months.

The investigator would like to keep track of the participant's medical condition for the rest of their life. The investigator would like to do this by calling the participant on the telephone once a year to see how the participant is doing. Keeping in touch with the participant and checking their condition every year helps the investigator look at the long-term effects of the research study. ;

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Lymphoma

• NCT number: NCT02135133
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2014
• Completion date: August 2024