Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
18 Years and older, Male and Female
CC-220-DLBCL-001 (primary)
NCI-2021-07064
2020-005705-71
Summary
This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or
CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The
dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab,
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and
R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose
expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in
combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or
CC-99282 will be explored with the addition of a new cohort only after the RP2D for the
CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined.
Eligibility
- Participants must satisfy the following criteria to be enrolled in the study:
- Is = 18 years of age at the time of signing the informed consent form (ICF).
- Participant has histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated, a-BCL according to 2016 WHO classification.
- Participant has International Prognostic Index (IPI) score 0-5 in Part 1 and IPI 2-5 in Part 2. For the CELMoD and polatuzumab-R-CHP cohort, the subject must also have IPI score 0 to 5 in Part 2A and IPI 2 to 5 in Part 2B.
- Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants must have the following laboratory values:
- Absolute neutrophil count (ANC) = 1.5 x 109/L or = 1.0 x 109/L in case of documented bone marrow involvement (> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF)
- Hemoglobin (Hb) = 8 g/dL
- Platelets (PLT) = 75 x 109/L or = 50 x 109/L in case of documented bone marrow involvement (>50% or tumor cells), without transfusion for 7 days
- Aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamate pyruvic transaminase (ALT/SGPT) = 2.5 x upper limit of normal (ULN). In the case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be = 5.0 x ULN.
- Serum total bilirubin = 2.0 mg/dL except in cases of Gilbert's syndrome, then = 5.0 mg/dl. Subjects receiving polatuzumab vedotin must have serum total bilirubin < 1.5 × ULN (26 µmol/L) (corresponding to mild degree as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria) except in cases of Gilbert's syndrome, then = 3.0 mg/dl (51 µmol/L).
- Estimated serum creatinine clearance (CrCl) of = 50 mL/min using the modification of diet in renal disease (MDRD) formula.
- All participants must:
- Have an understanding that the study drug could have a potential teratogenic risk.
- Agree to follow all requirements defined in the Pregnancy Prevention Program for CC-220 or CC-99282 Pregnancy Prevention Plan for Participants in Clinical trials.
- Females of childbearing potential (FCBP) must: a. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy.
- Male participants must:
- Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study.
Treatment Sites in Georgia
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com
6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.