Trial · NCT07444710
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
NCT07444710, Phase 1, Not yet recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma. Trials, record NCT07444710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07444710
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
- NCT number
- NCT07444710
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 16 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma, Ann Arbor Stage IV Mantle Cell Lymphoma
- Interventions
- Biospecimen Collection, Cisplatin, Computed Tomography, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Glofitamab, Positron Emission Tomography, Prednisone, Rituximab, Vincristine
- First posted
- 2026-03-03
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Up to 5 years | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 for all AEs other than cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), and hemophagocytic lymphohistiocytosis (HLH). CRS, ICANS, and HLH will be graded according to American Society for Transplantation and Cellular Therapy criteria. |
| Primary | Dose limiting toxicity (DLT) | From cycle 2, day 8 to cycle 5 day 1 (cycle length = 21 days) | DLT is defined as any grade 4 or higher CRS event, any grade CRS event that does not improve to \< grade 2 within 72 hours, any grade 3 or higher neurologic toxicity event including ICANS events, any grade 3 or higher non-hematologic toxicity, grade 3 aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation that does not resolve to grade 2 or less within 14 days, grade 4 AST or ALT is a DLT regardless of duration, grade 4 thrombocytopenia lasting more than 7 days, grade 3 thrombocytopenia with hemorrhage, grade 3 thrombocytopenia lasting ≥ 28 days or grade 4 neutropenia lasting ≥ 14 days despite the use of growth factors. |
| Secondary | Overall response rate | From completion of induction therapy, up to 5 years | Will be analyzed, based on positron emission tomography (PET)/computed tomography (CT) according to 2014 Lugano Response Criteria. |
| Secondary | Complete response rate | Up to 5 years | Will be analyzed, based on PET/CT according to 2014 Lugano Response Criteria. |
| Secondary | Partial response rate | Up to 5 years | Will be analyzed, based on PET/CT according to 2014 Lugano Response Criteria. |
| Secondary | Failure free survival | From enrollment to stable disease at the end of induction therapy, progressive disease, or death from any cause, up to 5 years | |
| Secondary | Overall survival | From enrollment to death from any cause, up to 5 years | |
| Other | Minimal residual disease negativity | After completion of induction therapy before initiation of maintenance therapy and every 6 months during maintenance therapy | |
| Other | Complete of at least 4 cycles of therapy (feasibility) | Up to 5 years | Feasibility, as defined as the completion of at least four cycles of therapy by 75% of subjects. |
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186717 | Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN | DANILOV, ALEXEY V.; COLEVAS, A. DIMITRIOS; LARA, PRIMO N.; LENZ, HEINZ JOSEF | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
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/NCT07444710
GET https://conductscience.org/api/trials/v1/NCT07444710/registered