Trial · NCT04646395
Study of Acalabrutinib and Tafasitamab in MZL Patients
NCT04646395, Phase 2, Active not recruiting, International Extranodal Lymphoma Study Group (IELSG)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Acalabrutinib and Tafasitamab in MZL Patients. Trials, record NCT04646395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04646395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Acalabrutinib and Tafasitamab in MZL Patients
- NCT number
- NCT04646395
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Conditions
- Marginal Zone Lymphoma
- Interventions
- Tafasitamab, Acalabrutinib
- First posted
- 2020-11-30
- Last updated
- 2026-04-06
- Other registries' IDs
- eudract:2019-004396-38
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate as best response to treatment | 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). |
| Secondary | Number of treatment emergent adverse events (AE) | From the time of informed consent signature until 28 days after treatment discontinuation or until resolution of all treatment-related AEs, whichever occurs later. | Analysis of type and severity of Adverse Events according to CTCAE v5.0 and relationship to study treatment |
| Secondary | Overall Response Rate (ORR) | Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days) | 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. |
| Secondary | Progression Free Survival (PFS) | 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 | 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 |
| Secondary | Duration of response (DoR) | 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 | 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). |
| Secondary | Overall Survival (OS) | From the date of treatment start to the date of death for any cause until 3 years from last treatment dose | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04646395
GET https://conductscience.org/api/trials/v1/NCT04646395/registered