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Follicular LymphomaPhase 2NCT06108232

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

A Phase 2 study testing Obinutuzumab and CC-99282 in people with Follicular Lymphoma and Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma, Tumor
What is being tested?
Obinutuzumab and CC-99282
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteUnited States
Study dates
15 Mar 2024to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Platelets ≤ 100 x 109/L
  • Absolute neutrophil count (ANC) < 1.5x109/L
  • Pleural effusion or ascites
  • Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion > 1 cm in longest diameter by CT, PET/CT, and/or MRI
  • Bulky disease is defined as > 10 cm in its greater diameter
  • Patients must have adequate organ and marrow function as defined below:
  • Total bilirubin ≤ 1.5 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin > 5)
  • AST and ALT ≤ 3x upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 ULN
  • Creatinine clearance >50 ml/min calculated by modified Cockcroft-Gault formula
  • Blood counts below if without bone marrow lymphoma involvement
  • Hemoglobin ≥ 8 g/dL
  • Platelets ≥ 75 x 109/L
  • Absolute neutrophil count (ANC) ≥ 1.5x109/L
  • All subjects must:
  • Have an understanding that the study drug could have a potential teratogenic risk.
  • Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.
  • Agree not to share study medication with another person.
  • Agree to follow all requirements defined in the Pregnancy Prevention Program (see Appendix 14.1) for CC-99282 Pregnancy Prevention Plan for Subjects in Clinical trials.
  • Females must agree to abstain from breastfeeding while taking CC-99282 and for at least 6 months and 2 weeks after the last dose of CC-99282
  • Females of childbearing potential (FCBP§) must:
  • Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting IP, during the study treatment (including dose interruptions), and for 6 months and 2 weeks for women and 3 months and 2 weeks for men after the last dose of CC-99282 and for 12 months after the last dose of obinutuzumab, whichever is longer. Contraception requirements are detailed in Appendix 14.1.
  • Male subjects must:
  • Practice true abstinence* (which must be reviewed on a monthly basis and source documented) or agree to use a condom (Appendix 14.1) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months and 2 weeks after the last dose of CC-99282 or obinutuzumab, whichever is longer, even if he has undergone a successful vasectomy.
  • Must agree to refrain from donating sperm while on study treatment, during dose interruptions, and for at least 3 months and 2 weeks after the last dose of CC-99282 or obinutuzumab, whichever is longer.
  • Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
  • The investigator is responsible for: ensuring that the patient understands the potential risks and benefits of participating in the study; ensuring that informed consent is given by each patient, this includes obtaining the appropriate signatures and dates on the informed consent document prior to the performance of any study procedures and prior to the administration of study treatment; answering any questions the patient may have throughout the study and sharing in a timely manner any new information that may be relevant to the patient's willingness to continue his or her participant in the trial. Subjects will undergo a brief physical exam including a brief exam to determine cognitive review. No one without capacity to personally consent will be enrolled. Patients have medical decision-making capacity if they can demonstrate understanding of the situation, appreciation of the consequences of their decision, and reasoning in their thought process, and if they can communicate their wishes.
  • A determination of lack of decision-making capacity shall be made after an appropriate medical evaluation that concludes there is little or no likelihood that the participant will regain decision-making capacity in a reasonable period of time.
  • §A FCBP is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  • True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Who cannot join

  • 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
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  • 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.
  • Vaccinated with live, attenuated vaccines within 4 weeks of study entry.
  • Lactating or pregnant subjects
  • Administration of any investigational agent within 28 days of first dose of study drug.
  • Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.
  • Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisone (over these 4 weeks).
  • Life expectancy < 6 months
  • Neuropathy > Grade 1
  • Prior exposure to CD20 mAb or IMiDs, independently from indication
  • Patients who have difficulty with or are unable to swallow oral medication, or have disease significantly affecting gastrointestinal function that would limit absorption of oral medication
  • Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Patients who have a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Known history of symptomatic deep vein thrombosis or pulmonary embolism
  • Known history of Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) or drug rash with eosinophilia and systemic symptoms (DRESS)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dai Chihara, M D, PhD contact

713-792-2860

dchihara@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Dai Chihara, M D, PhD, 713-792-2860, dchihara@mdanderson.org

    Dai Chihara, M D, PhD

    Recruiting

Other trials in United States

About this study

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

Read the detailed description

Objectives:

Primary Objectives:

  • To determine the efficacy of obinutuzumab in combination with CC-99282 as determined by complete response (CR) rate after six cycles of combination treatment for patients with previously untreated, high tumor burden follicular lymphoma (FL).

Secondary Objectives:

  • To determine best overall response rate (ORR), duration of response (DOR), time to next treatment, CR rate at 30 months (CR30), progression-free survival (PFS), overall survival (OS), and evaluation of safety of obinutuzumab and CC-99282 as treatment for previously untreated patients with FL.

Exploratory Objective:

  • To determine the biomarkers that correlates with response and mechanisms of resistance to obinutuzumab and CC-99282 in FL.
  • To determine the quality of life in patients with FL receiving obinutuzumab and CC-99282
Being tested
Obinutuzumab, CC-99282
Medical subject headings
Lymphoma, Follicular, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called GA101, Gazyva, RO5072759

    Given by IV (vein)

  • CC-99282Drug

    Given by PO

Study groups in NCT06108232
Study groupRoleWhat they receive
Obinutuzumab+CC-99282ExperimentalParticipants 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.
Receives: Drug: Obinutuzumab; Drug: CC-99282

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: through study completion; an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start15 Mar 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108232
Sponsor's protocol ID
2023-0063
Other IDs
NCI-2023-09268
Status last verified
Oct 2026
First submitted
25 Oct 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab and CC-99282 in people with Follicular Lymphoma and Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dai Chihara, M D, PhD (713-792-2860, dchihara@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06108232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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