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Ann Arbor Stage II Grade 1 Follicular LymphomaPhase 2NCT02871219

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

A Phase 2 study testing Lenalidomide and Obinutuzumab in people with Ann Arbor Stage II Grade 1 Follicular Lymphoma and Ann Arbor Stage II Grade 2 Follicular Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lenalidomide and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
6 Dec 2016to 26 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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,
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  • 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:
  • Hemoglobin =< 10 g/dL
  • Platelets =< 100 x 10^9/L
  • Absolute neutrophil count (ANC) < 1.5 x 10^9/L
  • Pleural or peritoneal effusion
  • Lactate dehydrogenase (LDH) > upper limit of normal (ULN) or beta-2 microglobulin > ULN
  • Stage II, III, or IV disease
  • Eastern cooperative oncology group (ECOG) performance status =< 2
  • Absolute neutrophil count (ANC) > 1.0 x 10^9/L
  • Platelet count > 75 x 10^9/L
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
  • Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula
  • Bilirubin < 1.5 x ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
  • Women of childbearing potential and men who are sexually active must practice reliable contraceptive measures started at least 4 weeks before study therapy and continued for at least 4 weeks following discontinuation therapy; females of childbearing potential must either completely abstain from heterosexual sexual contact or must use 2 methods of reliable contraception; reliable contraceptive methods include 1 highly effective method (intrauterine device, birth control pills, hormonal patches, injections, vaginal rings, or implants) and at least 1 additional method (condom, diaphragm, or cervical cap) every time they have sex with a male; males who are sexually active must be practicing complete abstinence or agree to a condom during sexual contact with a pregnant female or female of child bearing potential; men must agree to not donate sperm during and after the study
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
  • All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of the REMS program
  • Sign (or their legally-acceptable representatives must 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

Who cannot join

  • 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
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  • 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
  • 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 14 days
  • Patients with the following:
  • Bleeding diathesis or patients in whom prophylactic antithrombotic therapy is otherwise contraindicated
  • Patients with prior deep vein thrombosis (DVT), pulmonary embolism (PE), or arterial thromboembolism
  • Patients with ischemic stroke or transient ischemic attack (TIA)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Obinutuzumab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of obinutuzumab combined with lenalidomide in patients with previously untreated follicular lymphoma (FL) (determined by progression-free survival [PFS] at 2 years).

SECONDARY OBJECTIVES:

  1. To evaluate the safety of obinutuzumab in combination with lenalidomide in patients with untreated follicular lymphoma.

II. To evaluate the efficacy of obinutuzumab in combination with lenalidomide in subjects with follicular lymphoma as assessed by complete remission (CR) at 30 months, overall response rate (ORR), duration of response (DOR), event free survival (EFS), and overall survival (OS).

EXPLORATORY OBJECTIVES:

  1. To evaluate prognostic and predictive biomarkers relative to treatment outcomes.

OUTLINE:

Patients receive obinutuzumab intravenously (IV) over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of courses 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 orally (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 complete remission unconfirmed (CRu) may receive up to an additional 12 courses of lenalidomide.

After completion of study treatment, patients are followed up every 6 months for 18 months and then every year for up to 2 years.

Medical subject headings
Fatigue, Fever, Splenomegaly, Weight Loss

What participants receive

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

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • ObinutuzumabBiological

    Also called Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva

    Given IV

Study groups in NCT02871219
Study groupRoleWhat they receive
Treatment (obinutuzumab, lenalidomide)ExperimentalPatients 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.
Receives: Drug: Lenalidomide; Biological: Obinutuzumab

What is being measured

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

  1. Progression Free Survival

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

    Measured: approximately 71 months

Secondary outcomes (5)

  1. Complete Response

    The number and percentage of subjects will be tabulated.

    Measured: 24 months

  2. Overall Response Rate (CR + Partial Response [PR])

    The number and percentage of subjects will be tabulated.

    Measured: 24 months

  3. Duration of Response

    Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.

    Measured: 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

  4. Event Free Survival

    Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.

    Measured: 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

  5. Overall Survival

    Kaplan-Meier methodology will be used to estimate event-free curves, median, and 95% CI.

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

Timeline

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

  1. First posted18 Aug 2016 (estimated)
  2. Study start6 Dec 2016
  3. Primary completion26 Jun 2024
  4. Study completion26 Jun 2024

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
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871219
Sponsor's protocol ID
2015-0464
Other IDs
NCI-2016-01506, 2015-0464
Status last verified
May 2025
First submitted
15 Aug 2016
Last updated
8 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40517417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and Obinutuzumab in people with Ann Arbor Stage II Grade 1 Follicular Lymphoma and Ann Arbor Stage II Grade 2 Follicular Lymphoma, 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 31 inclusion and 22 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: finished, as of the sponsor's last update on 8 Jun 2025. 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?

Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: approximately 71 months). 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 NCT02871219, which also lists 1 linked publication.

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 8 Jun 2025.

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