Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma

NCT06108232 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0063NCI-2023-09268
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if obinutuzumab in combination with CC-99282 can help to control previously untreated, high tumor burden FL

Conditions

Follicular Lymphoma; Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year.

Study Arms (1)

Obinutuzumab+CC-99282

EXPERIMENTAL

Participants will receive obinutuzumab and CC-99282 together for up to 12 study cycles. Each study cycle is 28 days. Participants will first receive the study drugs for Cycles 1-6. Then after participants complete Cycle 6, the study doctor will decide based on the status of the disease if participant will continue to receive the study drugs for Cycles 7-12 or if participant will stop receiving them.

Drug: Obinutuzumab; Drug: CC-99282

Interventions

Obinutuzumab DRUG

Given by IV (vein)

Also known as: GA101, Gazyva, RO5072759

Obinutuzumab+CC-99282

CC-99282 DRUG

Given by PO

Obinutuzumab+CC-99282

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet the following criteria for study entry:
• Histologically diagnosed follicular lymphoma grade 1-3a
• Have no prior systemic treatment for lymphoma
• Stage II, III or IV disease
• Age ≥18 years
• Performance status ≤2 on the ECOG scale
• High-tumor burden disease based on GELF criteria36
• A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter
• At least 3 nodal or extranodal sites ≥ 3 cm in diameter
• Presence of at least one B symptom
• Fever (\>38 ℃), night sweats, weight loss \> 10% in the past 6 months
• Symptomatic splenomegaly (or size \>13cm)
• Impending organ compression or involvement (ureteral, orbital, gastrointestinal)
• Any of the following cytopenias due to bone marrow involvement of lymphoma
• Hemoglobin ≤ 10 g/dL

You may not qualify if:

• Subjects will be ineligible for this study if they meet any of following criteria:
• Known active central nervous system lymphoma or leptomeningeal disease
• Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:
• Adequately treated localized skin cancer without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue risk
• Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2
• Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
• History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \>10mg/day of prednisone) within 28 days of the first dose of study drug
• Requires chronic treatment with strong CYP3A inhibitors (List in Table 1). Patients can be eligible after discontinuation of the perpetrator and a sufficient washout period of 7-days or 5 half-lives, whichever is longer.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study
• Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block.
• QTcF ≥ 470 msec
• Active bleeding or known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia
• History of stroke or intracranial hemorrhage within 6 months prior to study entry.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma, Follicular; Neoplasms

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dai Chihara, M D, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dai Chihara, M D, PhD

CONTACT

713-792-2860; dchihara@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 30, 2023
• Study Start: March 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)