Marginal Zone LymphomaPhase 2NCT04646395
Study of Acalabrutinib and Tafasitamab in MZL Patients
A Phase 2 study testing Tafasitamab and Acalabrutinib in people with Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 9 sites in 3 countries.
Trial summary
This is a multicenter open label phase II trial in patients with previously treated Marginal Zone Lymphomas. The aim of the study is to evaluate the efficacy and the safety of tafasitamab in combination with acalabrutinib. 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?
- Tafasitamab and Acalabrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 20 Oct 2021to 15 Mar 2028
- 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
- Ability to understand and willingness to sign a written informed consent
- Histologically confirmed diagnosis of MZL.
- Disease refractory to or in first or greater relapse after prior systemic therapy.
- In need of treatment disease satisfying the following criteria:
- EMZL: symptomatic lymphoma or with other treatment indications (overt progression, deep invasion, bulky disease, impending organ damage, patient preference), symptomatic disseminated disease, contraindications to RT, failure after antibiotics or after local therapy,
- SMZL: presence of progressive or symptomatic splenomegaly and/ or any progressive cytopaenias,
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- NMZL: B symptoms, deterioration of peripheral blood counts due to lymphoma infiltration of the bone marrow, rapid enlargement of lymph nodes or compression of vital organs by bulky disease.
- Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations).
- Ann Arbor Stage I-IV.
- ECOG performance status of 0, 1 or 2 with no deterioration over the previous 2 weeks prior to registration .
- Age ≥ 18 years.
- Absolute neutrophil count (ANC) ≥ 1.000/mm3 and platelets ≥ 100.000/mm3, unless these abnormalities are related to bone marrow infiltration or to hypersplenism.
- Adequate hepatic function, renal function and coagulation parameters
- Women with childbearing potential who are using highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and for at least 3 months after the last IMP dose.
- Men who agree not to father a child during trial treatment and for at least 3 months after the last IMP dose.
- Patient able and willing to swallow trial drugs as whole capsule
Who cannot join
- History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:
- Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study,
- Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥3 years without further treatment.
- Major surgery and any systemic anti-cancer treatment within 3 weeks prior to registration.
- Prior exposure to a BTK inhibitor or CD19-targeted therapy.
- Steroid therapy for anti-neoplastic intent.
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- Severe or uncontrolled cardiovascular disease
- History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration and known bleeding disorders
- Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML).
- Concomitant diseases that require anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists and patients treated with dual anti-platelet therapy. Patients being treated with factor Xa inhibitors (e.g. rivaroxaban, apixaban, edoxaban), direct thrombin inhibitors (e.g. dabigatran) LMWH, or single anti-platelets agents (e.g. aspirin, clopidogrel) can be included, but must be properly informed about the potential risk of bleeding.
- Malabsorption syndrome or other condition that precludes enteral route of administration.
- Active human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
- Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune. thrombocytopenia) requiring steroid therapy with > 20 mg daily of prednisone dose or equivalent.
- Known hypersensitivity to trial drugs or to any component of the trial drugs.
- Concomitant treatment with strong CYP3A inducers or inhibitors
- Treatment with proton pump inhibitors. Subjects receiving proton pump inhibitors who switch to antacids are eligible for enrollment to this study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with trial participation or IMPs administration or may interfere with the interpretation of trial results and/or would make the patient inappropriate for enrolment into this trial.
- Concurrent participation in another therapeutic clinical trial
- History of or ongoing confirmed central nervous system (CNS) lymphoma
- Patients who received any IMP within 30 days or 5 half-lives (whichever is shorter) before the first dose of the study IMP
- Pregnant or breastfeeding women
- Patients who received a live virus vaccination within 28 days of the first IMP dose
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Italy7 sites
ASST Spedali Civili di Brescia
Brescia
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan
Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
Milan
Ospedale Maggiore della Carità
Novara
AUSL Ravenna U.O. Ematologia
Ravenna, 48121
Azienda Ospedaliera - IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia
Ospedale di Circolo e Fondazione Macchi - ASST Sette Laghi
Varese
Switzerland1 site
Oncology Institute of Southern Switzerland
Bellinzona, 6500
About this study
Official title: Phase II Trial of Acalabrutinib in Combination With Tafasitamab in Patients With Previously Treated Marginal Zone Lymphomas (MZL)
This is a multicenter open label phase II trial in patients with previously treated Marginal Zone Lymphomas.
The aim of the study is to evaluate the efficacy and the safety of tafasitamab in combination with acalabrutinib.
Read more
Twenty-four patients are expected to be enrolled and treated every 28 days with acalabrutinib and tafasitamab for 24 cycles.
The study consists of two parts, which are performed sequentially. The first part is a safety run-in to evaluate the safety data once 6 patients (representing the 25% of the total cohort) have completed the first cycle of treatment. An Independent Data Monitoring Committee (IDMC) will provide an independent assessment of this evaluation.
The second part starts after the outcome of this evaluation and will include the remaining 18 patients. The 6 patients of the safety run-in phase will be considered for the final evaluation of the study.
Between 11 - 13 weeks, patients showing partial or complete response (PR, CR) will continue treatment, while patients showing stable disease (SD) will discontinue it. However, patients in SD who benefit from therapy may continue to be treated, after agreement between the Investigator and the Sponsor.
Patients who complete the 24 cycles of treatment will enter the follow-up phase up to 3 years from patient's last study treatment dose (about 5 years from treatment start).
Patients who discontinue treatment before cycle 24 for any reason will be followed for up to 3 years (every 6 months for the first year and yearly for the second and third year) from the patient's last study treatment dose.
.
Read the detailed description
Marginal zone B cell lymphomas (MZLs) comprise three distinct entities: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue type (MALT) lymphoma, splenic MZL (SMZL) and nodal MZL (NMZL).
Together they represent approximately 5%-15% of all non-Hodgkin lymphomas.
MZL are in general indolent lymphomas with relatively low risk of transformation. The available treatment options can lead to responses but disease recurrence is often observed. For patients with MZL and recurrent disease following initial treatment, currently there is no established standard therapy and new treatment options and treatment combinations are needed.
The proposed trial will evaluate the safety and efficacy of the anti-CD19 monoclonal antibody tafasitamab in combination with the BTK inhibitor acalabrutinib. The B-lymphocyte, lineage specific surface antigen CD19 is broadly and homogeneously expressed in MZLs. This makes CD19 an attractive target for the treatment of MZL patients, in particular those who failed a previous rituximab-containing regimen.
On the other hand, genetic and immunogenetic data point to B-cell receptor signalling as a key oncogenic pathway of MZLs. The activity of single agent ibrutinib in MZLs is an in vivo proof that MZLs are addicted of BTK-driven signalling and that the BCR pathway is a vulnerability of these lymphomas.
The safety profile of the anti CD19 monoclonal antibody tafasitamab and of the BTK inhibitor acalabrutinib indicate the possibility that their combination can be developed without major overlapping side effects.
The proposed trial is a prospective multicenter trial combining tafasitamab and acalabrutinib in patients with MZL (including EMZL, SMZL and NMZL) with disease refractory to or in first or greater relapse after prior systemic therapy.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- Tafasitamab, Acalabrutinib
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafasitamabDrug
Also called MOR00208
200 mg powder for reconstitution with 5 ml water for injection
AcalabrutinibDrug
Also called Calquence
100 mg hard gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Tafasitamab and Acalabrutinib | Experimental | Acalabrutinib will be administered continuously at the dose of 100 mg BID (equivalent to a total daily dose of 200 mg), from day 1 to day 28 of each cycle for 24 cycles.
Tafasitamab will be administered 12 mg/kg iv on days 1, 8, 15 and 22 for the first 3 cycles. Then patients will continue treatment until cycle 24 with tafasitamab 12mg/kg iv on day 1 Receives: Drug: Tafasitamab; Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate as best response to treatment
defined according to the international Revised Response Criteria for Malignant Lymphoma (Cheson et al 2014). For patients with SMZL, response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas, histological response is evaluated according to GELA scoring system (Copie-Bergman et al 2003).
Measured: Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days)
Secondary outcomes (5)
Number of treatment emergent adverse events (AE)
Analysis of type and severity of Adverse Events according to CTCAE v5.0 and relationship to study treatment
Measured: From the time of informed consent signature until 28 days after treatment discontinuation or until resolution of all treatment-related AEs, whichever occurs later.
Overall Response Rate (ORR)
ORR will be defined as sum of PR plus CR defined according to the revised response criteria for malignant lymphomas (Cheson et al 2014), to the GELA Histological Grading System for gastric EMZL and the Matutes criteria for SMZL.
Measured: Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days)
Progression Free Survival (PFS)
PFS will be computed from the first IMP dose to date of disease progression or date of death for any reason or censored at the date of the last follow-up visit, whichever occurs earlier
Measured: From the date of treatment start to the date of progression or the date of death for any cause until 3 years from last treatment dose
Duration of response (DoR)
DOR will be define as the time between the first documented response to therapy and subsequent disease progression or relapse or death according to the international Revised Response Criteria for Malignant Lymphoma (Cheson et al 2014).
Measured: From the date of the first documented response to the date of disease progression or relapse or death until 3 years from last treatment dose
Overall Survival (OS)
Overall survival (OS) will be computed from the first IMP dose to the date of death for any reason or censored at the date of the last contact, whichever occurs earlier
Measured: From the date of treatment start to the date of death for any cause until 3 years from last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start20 Oct 2021
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasios Stathis, MD, Study chair, Oncology Institute of Southern Switzerland - Bellinzona, SwitzerlandDavide Rossi, MD, Study chair, Oncology Institute of Southern Switzerland - Bellinzona, CHEmanuele Zucca, MD, Study chair, Oncology Institute of Southern Switzerland - Bellinzona, CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646395
- Sponsor's protocol ID
- IELSG49
- Other IDs
- 2019-004396-38, 2019
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2020
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Acalabrutinib in Combination With Tafasitamab in Patients With Previously Treated Marginal Zone Lymphomas (MZL)
- ClinicalTrials.gov ID
- NCT04646395
- Acronym / sponsor ID
- IELSG49
- Conditions
- Marginal Zone Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 30 Nov 2020 (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.
This is a multicenter open label phase II trial in patients with previously treated Marginal Zone Lymphomas.
The aim of the study is to evaluate the efficacy and the safety of tafasitamab in combination with acalabrutinib.
Twenty-four patients are expected to be enrolled and treated every 28 days with acalabrutinib and tafasitamab for 24 cycles.
The study consists of two parts, which are performed sequentially. The first part is a safety run-in to evaluate the safety data once 6 patients (representing the 25% of the total cohort) have completed the first cycle of treatment. An Independent Data Monitoring Committee (IDMC) will provide an independent assessment of this evaluation.
The second part starts after the outcome of this evaluation and will include the remaining 18 patients. The 6 patients of the safety run-in phase will be considered for the final evaluation of the study.
Between 11 - 13 weeks, patients showing partial or complete response (PR, CR) will continue treatment, while patients showing stable disease (SD) will discontinue it. However, patients in SD who benefit from therapy may continue to be treated, after agreement between the Investigator and the Sponsor.
Patients who complete the 24 cycles of treatment will enter the follow-up phase up to 3 years from patient's last study treatment dose (about 5 years from treatment start).
Patients who discontinue treatment before cycle 24 for any reason will be followed for up to 3 years (every 6 months for the first year and yearly for the second and third year) from the patient's last study treatment dose.
.
Detailed description
Marginal zone B cell lymphomas (MZLs) comprise three distinct entities: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue type (MALT) lymphoma, splenic MZL (SMZL) and nodal MZL (NMZL).
Together they represent approximately 5%-15% of all non-Hodgkin lymphomas.
MZL are in general indolent lymphomas with relatively low risk of transformation. The available treatment options can lead to responses but disease recurrence is often observed. For patients with MZL and recurrent disease following initial treatment, currently there is no established standard therapy and new treatment options and treatment combinations are needed.
The proposed trial will evaluate the safety and efficacy of the anti-CD19 monoclonal antibody tafasitamab in combination with the BTK inhibitor acalabrutinib. The B-lymphocyte, lineage specific surface antigen CD19 is broadly and homogeneously expressed in MZLs. This makes CD19 an attractive target for the treatment of MZL patients, in particular those who failed a previous rituximab-containing regimen.
On the other hand, genetic and immunogenetic data point to B-cell receptor signalling as a key oncogenic pathway of MZLs. The activity of single agent ibrutinib in MZLs is an in vivo proof that MZLs are addicted of BTK-driven signalling and that the BCR pathway is a vulnerability of these lymphomas.
The safety profile of the anti CD19 monoclonal antibody tafasitamab and of the BTK inhibitor acalabrutinib indicate the possibility that their combination can be developed without major overlapping side effects.
The proposed trial is a prospective multicenter trial combining tafasitamab and acalabrutinib in patients with MZL (including EMZL, SMZL and NMZL) with disease refractory to or in first or greater relapse after prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tafasitamab and Acalabrutinib | Experimental | Drug: Tafasitamab, Drug: AcalabrutinibAcalabrutinib will be administered continuously at the dose of 100 mg BID (equivalent to a total daily dose of 200 mg), from day 1 to day 28 of each cycle for 24 cycles. Tafasitamab will be administered 12 mg/kg iv on days 1, 8, 15 and 22 for the first 3 cycles. Then patients will continue treatment until cycle 24 with tafasitamab 12mg/kg iv on day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to understand and willingness to sign a written informed consent
- Histologically confirmed diagnosis of MZL.
- Disease refractory to or in first or greater relapse after prior systemic therapy.
- In need of treatment disease satisfying the following criteria:
- Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations).
Key exclusion criteria (22 listed)
- History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following:
- Major surgery and any systemic anti-cancer treatment within 3 weeks prior to registration.
- Prior exposure to a BTK inhibitor or CD19-targeted therapy.
- Steroid therapy for anti-neoplastic intent.
- Severe or uncontrolled cardiovascular disease
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 |
|---|---|---|
| TafasitamabAlso: MOR00208200 mg powder for reconstitution with 5 ml water for injection | Drug | Tafasitamab and Acalabrutinib |
| AcalabrutinibAlso: Calquence100 mg hard gelatin capsules | Drug | Tafasitamab and Acalabrutinib |
Primary outcome
Complete Response (CR) Rate as best response to treatment
Time frame: Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days)
defined according to the international Revised Response Criteria for Malignant Lymphoma (Cheson et al 2014). For patients with SMZL, response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas, histological response is evaluated according to GELA scoring system (Copie-Bergman et al 2003).
5 secondary outcomes
Number of treatment emergent adverse events (AE)
Time frame: From the time of informed consent signature until 28 days after treatment discontinuation or until resolution of all treatment-related AEs, whichever occurs later.
Overall Response Rate (ORR)
Time frame: Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days)
Progression Free Survival (PFS)
Time frame: From the date of treatment start to the date of progression or the date of death for any cause until 3 years from last treatment dose
Duration of response (DoR)
Time frame: From the date of the first documented response to the date of disease progression or relapse or death until 3 years from last treatment dose
Overall Survival (OS)
Time frame: From the date of treatment start to the date of death for any cause until 3 years from last treatment dose
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 Apr 2026.
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Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
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Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
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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.
Anastasios Stathis, MD study chair
Oncology Institute of Southern Switzerland - Bellinzona, Switzerland
Davide Rossi, MD study chair
Oncology Institute of Southern Switzerland - Bellinzona, CH
Emanuele Zucca, MD study chair
Oncology Institute of Southern Switzerland - Bellinzona, CH
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafasitamab and Acalabrutinib in people with Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 9 sites in 3 countries.
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 16 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Austria, Switzerland. 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 Response (CR) Rate as best response to treatment (time frame: Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days)). 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 6 Apr 2026.