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American Family Children's Hospital

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Protocol No. UW13096

Principal Investigator Kenkre, Vaishalee

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Objective The primary purpose of this study is to evaluate the safety and tolerability of combinations of three new compounds (CC-122, CC-223, and CC-292) being developed to treat DLBCL and to identify the highest doses tolerated by subjects to help guide the selection of doses to be studied as the compounds are further developed. Certain dose levels of the combinations will also include the drug rituximab, which is currently part of the standard therapy for DLCBL. CC-122 with rituximab will also be studied as a separate combination. The secondary purpose is to look for early signals that the treatment is working (for example, tumor shrinkage) and compare drug levels in the body when CC-223 and CC-292 are given together.

Treatment There are four different study drugs in this study. CC-122, CC-223 and CC-292 are drugs that have not been approved in any country for the treatment of any medical condition and is experimental (being tested) in this study. These drugs come in capsules that are taken by mouth and swallowed with water. Rituximab is approved by the Food and Drug Administration and the European Medicines Agency for the treatment of non-Hodgkin's Lymphoma, including DLBCL, and chronic lymphocytic leukemia (CLL).

Description The study is divided into four Arms, defined as follows:
Treatment Arm A: Doses of CC-122 + CC-223 +/- rituximab
Treatment Arm B: Doses of CC-122 + CC-292 +/- rituximab
Treatment Arm C: Doses of CC-223 + CC-292 +/- rituximab
Treatment Arm D: Doses of CC-122 + rituximab

After confirming that you are eligible to participate, the study doctor will assign you to a particular arm and dose level based on his or her medical assessment of your condition and the number of open slots in each treatment arm. You may be moved into a higher dose level if the study doctor and a safety committee made up of other doctors involved in the study and the sponsor decide it is safe to do so. The dose you receive may be too low to have the best effect, or so high that it causes bad side effects.

Key Eligibility Must 18 years of age or older.
Confirmed diagnosis of relapsed or refractory DLBCL (including transformed low grade lymphoma).
Must have had at least two prior standard treatment regimens and autologous stem cell transplant (ASCT) in chemotherapy sensitive patients. Enrollment will also include selected high-risk subjects prior to ASCT and subjects not otherwise eligible for ASCT.

Applicable Disease Sites Lymphoma

Status Open

Participating Institutions UW Hospital and Clinics