Non-Hodgkin's LymphomaPhase 2NCT03198026
Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas
A Phase 2 study testing Ibrutinib, Obinutuzumab and Laboratory Biomarker Analysis in people with Non-Hodgkin's Lymphoma and Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Follicular Lymphoma
- What is being tested?
- Ibrutinib, Obinutuzumab and Laboratory Biomarker Analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2018to 20 Feb 2032
- 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
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Previously untreated, histologically confirmed indolent non-hodgkin's lymphoma who have not received prior systemic therapy (prior radiation or steroid treatment is allowed) as follows:
- Follicular lymphoma (WHO classification grade 1, 2, or 3a)
- Marginal zone lymphoma including:
- Nodal and splenic MZL who have an indication for systemic therapy
- Extranodal MZL:
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- Non-gastric/non-cutaneous MZL requiring systemic therapy
- Cutaneous MZL will be eligible only if they have pathologically confirmed extra-cutaneous disease
- Gastric MZL only if stage IIIE/IV defined as lymph node involvement on both sides of the diaphragm or with disseminated extranodal disease such as bone marrow or additional extra nodal sites.
- Pathological diagnosis should be obtained by incisional or excisional tissue biopsy. Core biopsy is permissible if obtaining an incisional or excisional is not possible and if the grade can be assessed on the core biopsy. A core biopsy can also be used if deemed in the best interest of the patient in the opinion of the investigator.
- Patients must have stage II-IV disease.
- All patients should have measurable disease. Measurable disease is defined as a lymph node or tumor mass that is >1.5cm in at least one dimension by CT or the CT portion of the PET/CT.
- Documentation of CD20+ status.
- Patients must have an indication for therapy per standard modified GELF criteria including:
- Symptoms attributable to lymphoma
- B symptoms
- Threatened end-organ function
- Pleural effusions or peritoneal ascites
- Cytopenia secondary to lymphoma
- Leukemia
- Bulky disease (defined as: Single mass >7cm in diameter, or 3 or more masses >3cm in diameter)
- Splenomegaly
- And steady progression over at least 6 months.
- Age >18 years.
- ECOG performance status 0-2
- Patients must be able to swallow whole pills.
- Ability and willingness to comply with the requirements of the study protocol. When it is determined by the study investigator that a potential research participant is cognitively impaired, a surrogate consent from a caregiver or legally-authorized representative will be obtained. Caregiver or legally-authorized representative will ensure that they comply with the protocol in order for the subject to be considered eligible.
- Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for >1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative urine/serum pregnancy test upon study entry.
- Male female subjects who agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy. Female patients of reproductive potential who are not surgically sterile must practice adequate birth control for a minimum of twelve months post- treatment; male patients who are not surgically sterile must practice adequate birth control for a minimum of three months post-treatment.
- Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening, with the exception of pegylated GCSF (pegfilgrastim) and darbopoeitin which require at least 14 days prior to screening defined as:
- Absolute neutrophil count >1.5x109 cells/mm3
- Platelet count >50000 cells/mm3 (50x109/L)
- Hemoglobin >9.0 g/dL
- Adequate hepatic and renal function defined as:
- Serum aspartate transaminase or alanine transaminase <3.0 x ULN
- PT/INR <1.5 x ULN and aPTT <1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
- Estimated Creatinine Clearance >30 ml/min (Calculated according using Cockcroft-Gault formula)
- Bilirubin <1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome of non-hepatic origin)
- Patients with Child Pugh B or C liver failure will be excluded
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior history of malignancies unless the patient has been disease free for >5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapy.
- Prior therapy for lymphoma including chemotherapy or immunotherapy including ibrutinib/anti-CD20 agents.
- Corticosteroid use within 2 weeks prior to study treatment.
- Known prior significant hypersensitivity to obinutuzumab (not including infusion reactions) or Ibrutinib.
- Patients with evidence of large B cell transformation (transformed disease are not eligible).
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- Known central nervous system (CNS) involvement by lymphoma
- Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
- Concomitant use of warfarin or other Vitamin K antagonists
- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor (See Appendix 5).
- Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of cycle 1.
- Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1 (HTLV-1) seropositive status
- Viral hepatitis:
- Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of detectable serum hepatitis B - DNA viremia are not eligible for this study
- Patients with positive hepatitis B core antibody but with negative hepatitis B - DNA maybe considered for participation, but must agree to receive appropriate anti-hepatitis B viral therapy suppression therapy while on obinutuzumab and have hepatitis B DNA monitored every 4 weeks with real time PCR by the treating physician. These patients should be referred to a hepatologist or gastroenterologist for appropriate monitoring and management.
- Hepatitis C: Patients with positive hepatitis C serology unless HCV RNA is confirmed negative by PCR.
- Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment
- Patient is receiving other investigational drugs
- Prior chemotherapy for any other cancer within the last 2 years
- Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders
- Patients should not have an autoimmune disorder that requires active immunosuppression
- Patients should not have a history of uncontrolled seizures
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment on the study
- Patients should not have a stroke or intracranial hemorrhage within last 6 months.
- Prior Surgery: Patients may not have had major surgery within 28 days of enrollment, or minor surgery within 7 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
- Pregnant and nursing: Female patients must have a negative serum pregnancy test within 72 hrs prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 18 months following completion of protocol therapy.
- Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification (see Appendix 5).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase II, Single Arm, Open Label Multi-center Study of Obinutuzumab and Ibrutinib in the Front Line Treatment of Indolent Non-Hodgkin's Lymphomas
This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the efficacy of the combination of ibrutinib and obinutuzumab in chemotherapy naive patients with indolent lymphomas.
SECONDARY OBJECTIVES:
- To assess progression free survival rates and overall survival rates in indolent lymphomas.
II. To assess safety and tolerability of the combination. III. To evaluate response using positron emission tomography (PET) and correlate PET negativity with durability of response.
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses.
After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then 1 year later.
- Conditions
- Non-Hodgkin's Lymphoma, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Follicular Lymphoma, Ann Arbor Stage II Nodal Marginal Zone Lymphoma, Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Being tested
- Ibrutinib, Obinutuzumab, Laboratory Biomarker Analysis
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called 2-Propen-1-one, 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)-, BTK Inhibitor PCI-32765, CRA-032765
Given PO
ObinutuzumabBiological
Also called 949142-50-1, Anti-CD20 Monoclonal Antibody R7159, Gazyva, R7159
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ibrutinib, obinutuzumab) | Experimental | Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses.
After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. Receives: Drug: Ibrutinib; Biological: Obinutuzumab; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate in Patients With Newly Diagnosed Indolent Lymphoma Requiring Treatment, Including Complete Response and Partial Response
Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.
Measured: After 7 cycles of treatment; approximately 7 months
Secondary outcomes (8)
Partial Remission or Complete Remission in Patients Treated With Ibrutinib and Obinutuzumab
Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.
Measured: Two years
Progression Free Survival
Estimated using Kaplan-Meier method.
Measured: 1 year
Progression Free Survival
Estimated using Kaplan-Meier method.
Measured: 3 years
Progression Free Survival
Estimated using Kaplan-Meier method.
Measured: 5 years
Overall Survival
Estimated using Kaplan-Meier method.
Measured: 1 year
Overall Survival
Estimated using Kaplan-Meier method.
Measured: 3 years
Overall Survival
Estimated using Kaplan-Meier method.
Measured: 5 years
Incidence of Grade III-IV Toxicity
Assessed using Common Terminology Criteria for Adverse Events version 5.0. Will compute estimates toxicity rates, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start20 Feb 2018
- Primary completion24 Oct 2023
- Study completion20 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Pharmacyclics LLC.
- Responsible party
- Sponsor
- Investigators
- Ubaldo Martinez-Outschoorn, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198026
- Sponsor's protocol ID
- 17P.176
- Other IDs
- JT 10049
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2017
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single Arm, Open Label Multi-center Study of Obinutuzumab and Ibrutinib in the Front Line Treatment of Indolent Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT03198026
- Acronym / sponsor ID
- 17P.176
- Conditions
- Non-Hodgkin's Lymphoma, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Follicular Lymphoma, Ann Arbor Stage II Nodal Marginal Zone Lymphoma, Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc., Pharmacyclics LLC.
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 20 Feb 2032 (estimated)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.
Detailed description
PRIMARY OBJECTIVES:
- To assess the efficacy of the combination of ibrutinib and obinutuzumab in chemotherapy naive patients with indolent lymphomas.
SECONDARY OBJECTIVES:
- To assess progression free survival rates and overall survival rates in indolent lymphomas.
II. To assess safety and tolerability of the combination. III. To evaluate response using positron emission tomography (PET) and correlate PET negativity with durability of response.
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses.
After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then 1 year later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ibrutinib, obinutuzumab) | Experimental | Drug: Ibrutinib, Biological: Obinutuzumab, Other: Laboratory Biomarker AnalysisPatients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Previously untreated, histologically confirmed indolent non-hodgkin's lymphoma who have not received prior systemic therapy (prior radiation or steroid treatment is allowed) as follows:
- Pathological diagnosis should be obtained by incisional or excisional tissue biopsy. Core biopsy is permissible if obtaining an incisional or excisional is not possible and if the grade can be assessed on the core biopsy. A core biopsy can also be used if deemed in the best interest of the patient in the opinion of the investigator.
- Patients must have stage II-IV disease.
- All patients should have measurable disease. Measurable disease is defined as a lymph node or tumor mass that is >1.5cm in at least one dimension by CT or the CT portion of the PET/CT.
Key exclusion criteria (29 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior history of malignancies unless the patient has been disease free for >5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapy.
- Prior therapy for lymphoma including chemotherapy or immunotherapy including ibrutinib/anti-CD20 agents.
- Corticosteroid use within 2 weeks prior to study treatment.
- Known prior significant hypersensitivity to obinutuzumab (not including infusion reactions) or Ibrutinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibAlso: 2-Propen-1-one, 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)-, BTK Inhibitor PCI-32765, CRA-032765Given PO | Drug | Treatment (ibrutinib, obinutuzumab) |
| ObinutuzumabAlso: 949142-50-1, Anti-CD20 Monoclonal Antibody R7159, Gazyva, R7159Given IV | Biological | Treatment (ibrutinib, obinutuzumab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (ibrutinib, obinutuzumab) |
Primary outcome
Overall Response Rate in Patients With Newly Diagnosed Indolent Lymphoma Requiring Treatment, Including Complete Response and Partial Response
Time frame: After 7 cycles of treatment; approximately 7 months
Response will be assessed by the revised Lugano. Will compute estimates of response, along with corresponding confidence intervals, using appropriate exact methods that take into account the 2-stage design.
8 secondary outcomes
Partial Remission or Complete Remission in Patients Treated With Ibrutinib and Obinutuzumab
Time frame: Two years
Progression Free Survival
Time frame: 1 year
Progression Free Survival
Time frame: 3 years
Progression Free Survival
Time frame: 5 years
Overall Survival
Time frame: 1 year
Overall Survival
Time frame: 3 years
Overall Survival
Time frame: 5 years
Incidence of Grade III-IV Toxicity
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ubaldo Martinez-Outschoorn, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib, Obinutuzumab and Laboratory Biomarker Analysis in people with Non-Hodgkin's Lymphoma and Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 39 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 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?
Yes. Results are posted in the registry (first posted 18 Aug 2026). 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?
Overall Response Rate in Patients With Newly Diagnosed Indolent Lymphoma Requiring Treatment, Including Complete Response and Partial Response (time frame: After 7 cycles of treatment; approximately 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.