Obinutuzumab and Lenalidomide in Treating Patients With Previously Untreated Stage II-IV Grade 1-3a Follicular Lymphoma

NCT02871219 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0464NCI-2016-01506
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well obinutuzumab and lenalidomide work in treating patients with previously untreated stage II-IV grade 1-3a follicular lymphoma. Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving obinutuzumab and lenalidomide may work better in treating patients with previously untreated follicular lymphoma.

Conditions

Ann Arbor Stage II Grade 1 Follicular Lymphoma; Ann Arbor Stage II Grade 2 Follicular Lymphoma; Ann Arbor Stage III Grade 1 Follicular Lymphoma; Ann Arbor Stage III Grade 2 Follicular Lymphoma; Ann Arbor Stage IV Grade 1 Follicular Lymphoma; Ann Arbor Stage IV Grade 2 Follicular Lymphoma; Bulky Disease; Fatigue; Fever; Grade 3a Follicular Lymphoma; Night Sweats; Splenomegaly; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Will be calculated and corresponding 95% confidence interval (CI) will be derived.

  approximately 71 months

Secondary Outcomes (5)

• Complete Response

  24 months

• Overall Response Rate (CR + Partial Response [PR])

  24 months

• Duration of Response

  From the time by which measurement criteria for CR or PR, whichever is recorded first, is met until death or the first date by which progressive disease is documented, assessed up to 3 years

• Event Free Survival

  From the date of course 1, day 1 to the date of first documented progression, transformation to diffuse large B-cell lymphoma, initiation of new anti-lymphoma treatment, or death, assessed up to 3 years

• Overall Survival

  From the date of course 1, day 1 to the date of death regardless of cause, assessed up to 3 years

Study Arms (1)

Treatment (obinutuzumab, lenalidomide)

EXPERIMENTAL

Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide.

Drug: Lenalidomide; Biological: Obinutuzumab

Interventions

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (obinutuzumab, lenalidomide)

Obinutuzumab BIOLOGICAL

Given IV

Also known as: Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva, huMAB(CD20), R7159, RO 5072759

Treatment (obinutuzumab, lenalidomide)

Eligibility Criteria

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

You may qualify if:

• A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
• Able and willing to provide written informed consent and to comply with the study protocol
• Bi-dimensionally measurable disease, with at least one mass lesion \>= 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI)
• Must be in need of therapy as evidenced by at least one of the following criteria:
• Bulky disease defined as:
• A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter or,
• At least 3 nodal or extranodal sites \>= 3 cm in diameter
• Presence of at least one B symptom:
• Fever (\> 38 C) not due to infectious etiology
• Night sweats
• Weight loss \> 10% in the past 6 months
• Fatigue due to lymphoma
• Splenomegaly (\> 13 cm)
• Compression syndrome (ureteral, orbital, gastrointestinal)
• Any of the following cytopenias due to lymphoma:

You may not qualify if:

• Known active central nervous system lymphoma or leptomeningeal disease
• Follicular lymphoma with evidence of diffuse large B-cell transformation
• Grade 3b follicular lymphoma
• Any prior history of other malignancy besides follicular lymphoma, unless the patient has been free of disease for \>= 5 years and felt to be at low risk for recurrence by the treating physician, except:
• Adequately treated non-melanoma skin cancer or lentigo maligna 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
• Known history of human immunodeficiency virus (HIV), active hepatitis C virus, active hepatitis B virus infection, or any uncontrolled active systemic infection
• Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated
• Prior use of lenalidomide
• Concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \> 10 mg/day of prednisone) within 28 days of the first dose of study drug
• Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab
• 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
• Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block
• Vaccinated with live, attenuated vaccines within 4 weeks of study entry

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Akkad N, Feng L, Westin JR, Hagemeister FB, Lee HJ, Fayad L, Ahmed S, Nair R, Rodriguez MA, Strati P, Chihara D, Flowers CR, Claret L, Ibanez K, Wang M, Fowler NH, Henderson J, Davis RE, Neelapu SS, Green M, Nastoupil LJ. A phase 2 study of obinutuzumab combined with lenalidomide in previously untreated high tumor burden follicular lymphoma. Blood Adv. 2025 Sep 9;9(17):4396-4404. doi: 10.1182/bloodadvances.2025016483.

  PMID: 40517417 DERIVED

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Fatigue; Fever; Splenomegaly; Weight Loss

Interventions

Lenalidomide; obinutuzumab

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Hypertrophy; Pathological Conditions, Anatomical; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Jason Westin, MD
• Organization: The University of Texas MD Anderson Cancer Center

jwestin@mdanderson.org

(713) 792-3750

Study Officials

• Loretta J Nastoupil

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: August 15, 2016
• First Posted: August 18, 2016
• Study Start: December 6, 2016
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-05

Locations

US (1)