Marginal Zone LymphomaPhase 2NCT03322865
Obinutuzumab in Marginal Zone Lymphoma
A Phase 2 study testing Obinutuzumab in people with Marginal Zone Lymphoma, run by Christian Buske at 12 sites in Germany.
Trial summary
For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do not prevent relapse later on. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 12 sitesGermany
- Study dates
- 23 Nov 2018to Jan 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 have a proven pathological diagnosis of MZL.
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Confirmed CD20 positive de novo MALT Lymphoma following or being not eligible for local therapy (including surgery, radiotherapy) and antibiotics for H. pylori-positive gastric lymphoma arisen at any extranodal site
- Confirmed CD20 positive de novo splenic MZL following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) with symptomatic disease
- Confirmed CD20 positive de novo nodal MZL
- Patients in need of treatment:
Show all 48Show fewer
- For patients with symptomatic splenic, nodal, or non-gastric extranodal MZL disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator.
- For patients with symptomatic gastric extranodal MZL: Helicobacter pylori-negative disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator, or H. pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator - At least one bi-dimensionally measurable lesion (> 2 cm in its largest dimension by CT scan or MRI).
- In patients with splenic MZL, an enlarged spleen on CT scan or extending at least 2 cm below the costal margin by physical examination will constitute measurable disease providing that no explanation other than lymphomatous involvement is likely. For an enlarged liver to constitute the only measurable disease parameter, a liver biopsy showing proof of NHL in the liver is required.
- For SMZL:
- Bulky progressive or painful splenomegaly
- one of the following symptomatic/progressive cytopenias : Hb < 10 g/dL, or Plat < 80.000 /microL, or neutropenia < 1000 /microL, whatever the reason (autoimmune or hypersplenism or bone marrow infiltration)
- enlarged lymphoadenopathy or involvement of extranodal sites with or without cytopenia
- splenectomised patients with rapidly raising lymphocyte counts, development of lymphadenopathy or involvement of extranodal sites
- SMZL with concomitant hepatitis C infection who have not responded to or are relapsed after Interferon and/or Ribavirin (patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- For gastric MALT Lymphoma:
- H. pylori-negative cases following or being not eligible for local therapy (i.e., surgery, radiotherapy or antibiotics).
- Others:
- Age greater than 18 years
- Life expectancy >3 months.
- Baseline platelet Count 50, 109/L, if not due to BM Infiltration by the lymphoma, absolute neutrophil Count 0.75, 109/L
- Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment (unless due to underlying lymphoma):
- ASAT (SGOT): 3 times the upper limit of institutional laboratory normal value
- ALAT (SGPT): 3 times the upper limit of institutional laboratory normal value
- Total Bilirubin: 20 mg/L or 2 times the upper limit of institutional laboratory normal value, unless clearly related to the disease (except if due to Gilbert's syndrome)
- Serum creatininie <= 2mg/dl
- Pregnancy beta-HCG negative. For women of child-bearing potential only; serum or urine beta-HCG must be negative during screening and at study enrolment visit
- Negative HIV antibody
- Positive test results for chronic HBV infection (defined as positive HBsAg serology): patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing. Patients who have protective titers of HBSAb after vaccination or prior but cured hepatitis B are eligible.
- Positive test results for hepatitis C (hepatitis C virus (HCV) antibody serology testing): patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- Men must agree not to father a child for the duration of therapy and 6 months after and must agree to advice a female partner to use a highly effective method of birth control.
- Willingness and ability to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions.
- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation.
- The presence of any of the following will exclude a subject from enrolment:
- ECOG performance status >2
- History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥1 year prior to study enrollment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for ≥3 years.
- Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- Ann Arbor Stage I disease
- Ongoing immunosuppressive therapy other than corticosteroids
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrollment visit
- Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- Ongoing alcohol or drug addiction
- Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study
- Breastfeeding or pregnancy
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject or impair the assessment of study results.
- History of anaphylaxis in association with previous administration of monoclonal antibodies.
- Vaccination with a live vaccine within 28 days prior to start of therapy
Who cannot join
- The presence of any of the following will exclude a subject from enrolment:
- ECOG performance status >2
- History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥1 year prior to study enrollment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for ≥3 years.
- Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- Ann Arbor Stage I disease
- Ongoing immunosuppressive therapy other than corticosteroids
Show all 14Show fewer
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrollment visit
- Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- Ongoing alcohol or drug addiction
- Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study
- Breastfeeding or pregnancy
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject or impair the assessment of study results.
- History of anaphylaxis in association with previous administration of monoclonal antibodies.
- Vaccination with a live vaccine within 28 days prior to start of therapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Augusta-Kranken-Anstalt gGmbH
Bochum, 44791
University Hospital Essen
Essen, 45147
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Universitätsmedizin Georg-August-University
Göttingen, 37075
University Hospital Halle
Halle, 06120
Institut für Versorgungsforschung GbR
Koblenz, 56068
University Hospital Mainz
Mainz, 55101
Universitätsklinikum Mannheim
Mannheim, 68167
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, 48149
University Hospital Münster
Münster, 48149
Klinikum Passau
Passau, 94032
University Hospital Ulm
Ulm, 89081
About this study
Official title: Obinutuzumab in Marginal Zone Lymphoma (OLYMP-1)
For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do not prevent relapse later on. In addition, chemotherapy associated toxicity is often problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free approaches are highly attractive for this patient group. Rituximab single agent is a widely used chemotherapy - free approach in MZL, but was significantly inferior compared to Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001).Thus, it is the major aim to develop chemotherapy - free approaches for MZL, which approach efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in particular important in MZL as many physicians are reluctant to treat these often elderly patients with more intense treatments and prefer single agent therapies in these very often well and long responding lymphoma subtype. The type II anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) has demonstrated remarkable activity in follicular lymphoma and superiority to Rituximab in combination with chemotherapy in treatment naïve (Gallium trial) and rituximab refractory follicular lymphoma (Gadolin trial) as well as in CLL in combination with chlorambucil. Based on these observations it is the aim of this study to test the toxicity and efficacy of the anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) in patients with newly diagnosed MZL in need of treatment, who are not eligible or failed local therapy, following the assumption that this novel anti-CD20 antibody is significantly more effective than Rituximab single agent therapy, and avoids chemotherapy - related toxicity.
Read the detailed description
For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do not prevent relapse later on. In addition, chemotherapy associated toxicity is often problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free approaches are highly attractive for this patient group. Rituximab single agent is a widely used chemotherapy - free approach in MZL, but was significantly inferior compared to Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001).Thus, it is the major aim to develop chemotherapy - free approaches for MZL, which approach efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in particular important in MZL as many physicians are reluctant to treat these often elderly patients with more intense treatments and prefer single agent therapies in these very often well and long responding lymphoma subtype. The type II anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) has demonstrated remarkable activity in follicular lymphoma and superiority to Rituximab in combination with chemotherapy in treatment naïve (Gallium trial) and rituximab refractory follicular lymphoma (Gadolin trial) as well as in CLL in combination with chlorambucil. Based on these observations it is the aim of this study to test the toxicity and efficacy of the anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) in patients with newly diagnosed MZL in need of treatment, who are not eligible or failed local therapy, following the assumption that this novel anti-CD20 antibody is significantly more effective than Rituximab single agent therapy, and avoids chemotherapy - related toxicity. For efficacy the rate of complete remissions (according to the GELA criteria for gastric MALT or to the Cheson 2007 criteria for non-gastric extranodal, nodal and splenic MZL) after induction therapy will be primarily analysed. For toxicity treatment associated adverse events, quality of life and cumulative incidence of secondary malignancies will be documented.
The study is a multicenter, single-arm, open-label, phase II trial of 6 cycles of Obinutuzumab in the induction phase followed by a maintenance phase for a maximum of 12 infusions of Obinutuzumab every 8 weeks in patients aged ≥ 18 years with previously untreated MZL in need of treatment.
The study flow will be as follows:
- Previously untreated patients will be screened for eligibility for the trial. If the patient is eligible for the study, the patient will be registered before the first cycle of induction treatment.
- Patients who progress at any time point during induction are considered as treatment failure. They will be followed up for overall survival until death.
- Patients, who achieve at least a SD after induction treatment will be eligible to receive maintenance therapy with Obinutuzumab.
It is expected that a total of 56 patients at approximately 20 investigator sites will be registered. Every patient will receive treatment over a time period of 6 x 4 weeks, followed by a maintenance phase of every 8 weeks for a maximum of 12 infusions until progression or study drug - related intolerable toxicity. Patient will be monitored every 3 months for 2 additional years, subsequently every 6 months for three additional years.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- Obinutuzumab
- Keywords
- Obinutuzumab, Anti-CD20 antibody, Oncology
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called GA101
Induction:
Cycle 1 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1,8,15*
*In the case of suspected increased risk of severe IRR, the dose of obinutuzumab may be 100 mg intravenously on day 1 in cycle 1, 900 mg on day 2.
Cycle 2-6 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 Maintenance
Start 8 weeks after the last induction cycle for patients at least achieving a partial response after induction:
Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 every 8 weeks for a maximum of 12 infusions unless progression or study drug - related intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| One Arm | Experimental | Obinutuzumab i.v. Receives: Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission/Response (CR) rate
The complete Response rate (CR) is evaluated after the end of induction
Measured: 24 weeks
Secondary outcomes (9)
Progression free survival
Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
Measured: 24 weeks
Overall survival
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Measured: participants will be followed for their participation in the trial, an expected average of 8.6 years
Time to first response
Time to first response is defined as the time from the start of induction to first response (CR, PR).
Measured: participation will be followed for their participation in the trial, an expected average of 8.6 years
Time to best response under treatment (induction and maintenance)Time
Time to best response is defined as the time from the start of induction to best response the patient achieves (CR, PR).
Measured: participation will be followed for their participation in the trial, an expected average of 8.6 years
Response rate
The response rates (CR, PR) and overall response rate (CR, PR) are evaluated 4 weeks after the end of induction treatment.
Measured: 24 weeks
Best response
Best response is determined in the time interval from the start of induction therapy to end of follow-up.
Measured: participation will be followed for their participation in the trial, an expected average of 8.6 years
Time to Treatment failure
Time to treatment failure (TTF) is defined as the time of registration to discontinuation of therapy for any reason including death from any cause, progression, toxicity or add-on of new anti-cancer therapy. Patients alive without treatment failure are censored at the latest tumor assessment date.
Measured: participation will be followed for their participation in the trial, an expected average of 8.6 years
Remission duration
Remission duration will be calculated in patients with response (CR, PR) to induction from end of induction to the date of progression, relapse or death from any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.
Measured: participation will be followed for their participation in the trial, an expected average of 8.6 years
Cause specific survival
Cause specific survival is defined as the period from the induction registration to death from lymphoma or lymphoma related cause; death unrelated to MZoL is considered as a competing event.
Measured: participation will be followed for their participation in the trial, an expected average of 8.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start23 Nov 2018
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marginal Zone 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Buske
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulm, Optimapharm, Zentrum für Klinische Studien Ulm, X-act Cologne Clinical Research GmbH, Roche Pharma AG
- Responsible party
- Sponsor-investigator, Christian Buske, University of Ulm
- Investigators
- Christian Buske, MD, Principal investigator, University Hospital of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322865
- Sponsor's protocol ID
- OLYMP-1
- Other IDs
- 2017-003149-56, 2017
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2017
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grunenberg A, Kaiser LM, Woelfle S, Schmelzle B, Viardot A, Moller P, Barth TF, Muche R, Dreyhaupt J, Buske C. Phase II trial evaluating the efficacy and safety of the anti-CD20 monoclonal antibody obinutuzumab in patients with marginal zone lymphoma. Future Oncol. 2020 May;16(13):817-825. doi: 10.2217/fon-2020-0071. Epub 2020 Mar 30.
PubMed 32223334
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obinutuzumab in Marginal Zone Lymphoma (OLYMP-1)
- ClinicalTrials.gov ID
- NCT03322865
- Acronym / sponsor ID
- OLYMP-1
- Conditions
- Marginal Zone Lymphoma
- Keywords
- Obinutuzumab, Anti-CD20 antibody, Oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Christian BuskeUniversity, hospital or other
- Collaborators
- University of Ulm, Optimapharm, Zentrum für Klinische Studien Ulm, X-act Cologne Clinical Research GmbH, Roche Pharma AG
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do not prevent relapse later on. In addition, chemotherapy associated toxicity is often problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free approaches are highly attractive for this patient group. Rituximab single agent is a widely used chemotherapy - free approach in MZL, but was significantly inferior compared to Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001).Thus, it is the major aim to develop chemotherapy - free approaches for MZL, which approach efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in particular important in MZL as many physicians are reluctant to treat these often elderly patients with more intense treatments and prefer single agent therapies in these very often well and long responding lymphoma subtype. The type II anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) has demonstrated remarkable activity in follicular lymphoma and superiority to Rituximab in combination with chemotherapy in treatment naïve (Gallium trial) and rituximab refractory follicular lymphoma (Gadolin trial) as well as in CLL in combination with chlorambucil. Based on these observations it is the aim of this study to test the toxicity and efficacy of the anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) in patients with newly diagnosed MZL in need of treatment, who are not eligible or failed local therapy, following the assumption that this novel anti-CD20 antibody is significantly more effective than Rituximab single agent therapy, and avoids chemotherapy - related toxicity.
Detailed description
For marginal zone lymphoma (MZL) Rituximab in combination with conventional chemotherapy are widely used for those patients who fail local therapy or do not qualify for such. Depending on the MZL subtype Rituximab/chemotherapy is able to induce in part long remissions, but do not prevent relapse later on. In addition, chemotherapy associated toxicity is often problematic in MZL patients, who are mostly of advanced age. Thus, chemotherapy - free approaches are highly attractive for this patient group. Rituximab single agent is a widely used chemotherapy - free approach in MZL, but was significantly inferior compared to Rituximab/chlorambucil in a large randomized prospective clinical trial in treatment naïve MZL with a CR rate of 56 % vs. 80%, respectively (P<0.001).Thus, it is the major aim to develop chemotherapy - free approaches for MZL, which approach efficacy of rituximab/chemotherapy combinations, but avoid chemotherapy associated toxicities. This in particular important in MZL as many physicians are reluctant to treat these often elderly patients with more intense treatments and prefer single agent therapies in these very often well and long responding lymphoma subtype. The type II anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) has demonstrated remarkable activity in follicular lymphoma and superiority to Rituximab in combination with chemotherapy in treatment naïve (Gallium trial) and rituximab refractory follicular lymphoma (Gadolin trial) as well as in CLL in combination with chlorambucil. Based on these observations it is the aim of this study to test the toxicity and efficacy of the anti-CD20 antibody Obinutuzumab (OBINUTUZUMAB) in patients with newly diagnosed MZL in need of treatment, who are not eligible or failed local therapy, following the assumption that this novel anti-CD20 antibody is significantly more effective than Rituximab single agent therapy, and avoids chemotherapy - related toxicity. For efficacy the rate of complete remissions (according to the GELA criteria for gastric MALT or to the Cheson 2007 criteria for non-gastric extranodal, nodal and splenic MZL) after induction therapy will be primarily analysed. For toxicity treatment associated adverse events, quality of life and cumulative incidence of secondary malignancies will be documented.
The study is a multicenter, single-arm, open-label, phase II trial of 6 cycles of Obinutuzumab in the induction phase followed by a maintenance phase for a maximum of 12 infusions of Obinutuzumab every 8 weeks in patients aged ≥ 18 years with previously untreated MZL in need of treatment.
The study flow will be as follows:
- Previously untreated patients will be screened for eligibility for the trial. If the patient is eligible for the study, the patient will be registered before the first cycle of induction treatment.
- Patients who progress at any time point during induction are considered as treatment failure. They will be followed up for overall survival until death.
- Patients, who achieve at least a SD after induction treatment will be eligible to receive maintenance therapy with Obinutuzumab.
It is expected that a total of 56 patients at approximately 20 investigator sites will be registered. Every patient will receive treatment over a time period of 6 x 4 weeks, followed by a maintenance phase of every 8 weeks for a maximum of 12 infusions until progression or study drug - related intolerable toxicity. Patient will be monitored every 3 months for 2 additional years, subsequently every 6 months for three additional years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Arm | Experimental | Drug: ObinutuzumabObinutuzumab i.v. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- Patients must have a proven pathological diagnosis of MZL.
- Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Confirmed CD20 positive de novo MALT Lymphoma following or being not eligible for local therapy (including surgery, radiotherapy) and antibiotics for H. pylori-positive gastric lymphoma arisen at any extranodal site
- Confirmed CD20 positive de novo splenic MZL following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) with symptomatic disease
- Confirmed CD20 positive de novo nodal MZL
Key exclusion criteria (14 listed)
- ECOG performance status >2
- History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥1 year prior to study enrollment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for ≥3 years.
- Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- Ann Arbor Stage I disease
- Ongoing immunosuppressive therapy other than corticosteroids
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 |
|---|---|---|
| ObinutuzumabAlso: GA101Induction: Cycle 1 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1,8,15* *In the case of suspected increased risk of severe IRR, the dose of obinutuzumab may be 100 mg intravenously on day 1 in cycle 1, 900 mg on day 2. Cycle 2-6 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 Maintenance Start 8 weeks after the last induction cycle for patients at least achieving a partial response after induction: Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 every 8 weeks for a maximum of 12 infusions unless progression or study drug - related intolerable toxicity | Drug | One Arm |
Primary outcome
Complete Remission/Response (CR) rate
Time frame: 24 weeks
The complete Response rate (CR) is evaluated after the end of induction
9 secondary outcomes
Progression free survival
Time frame: 24 weeks
Overall survival
Time frame: participants will be followed for their participation in the trial, an expected average of 8.6 years
Time to first response
Time frame: participation will be followed for their participation in the trial, an expected average of 8.6 years
Time to best response under treatment (induction and maintenance)Time
Time frame: participation will be followed for their participation in the trial, an expected average of 8.6 years
Response rate
Time frame: 24 weeks
Best response
Time frame: participation will be followed for their participation in the trial, an expected average of 8.6 years
Time to Treatment failure
Time frame: participation will be followed for their participation in the trial, an expected average of 8.6 years
Remission duration
Time frame: participation will be followed for their participation in the trial, an expected average of 8.6 years
Cause specific survival
Time frame: participation will be followed for their participation in the trial, an expected average of 8.6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 32223334Grunenberg A, Kaiser LM, Woelfle S, Schmelzle B, Viardot A, Moller P, Barth TF, Muche R, Dreyhaupt J, Buske C. Phase II trial evaluating the efficacy and safety of the anti-CD20 monoclonal antibody obinutuzumab in patients with marginal zone lymphoma. Future Oncol. 2020 May;16(13):817-825. doi: 10.2217/fon-2020-0071. Epub 2020 Mar 30.
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Active, not recruitingPhase 2/3
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
Not yet recruitingPhase 3
Orelabrutinib Plus ICP 248 vs Orelabrutinib for Relapsed/Refractory Marginal Zone Lymphoma
Relapsed/Refractory Marginal Zone Lymphoma (MZL)
RecruitingPhase 3
A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
Follicular Lymphoma, Marginal Zone Lymphoma
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.
Christian Buske, MD principal investigator
University Hospital of Ulm
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab in people with Marginal Zone Lymphoma, run by Christian Buske at 12 sites in Germany.
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 48 inclusion and 14 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. 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?
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?
Complete Remission/Response (CR) rate (time frame: 24 weeks). 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 NCT03322865, 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 6 May 2026.