Trial · NCT04047797
Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT04047797, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2024-12-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma. Trials, record NCT04047797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04047797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
- NCT number
- NCT04047797
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
- Interventions
- Ixazomib, Ixazomib Citrate, Rituximab
- First posted
- 2019-08-07
- Last updated
- 2025-04-20
- Results first posted
- 2024-12-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Remission Rate at 16 Weeks | 16 weeks | Evaluate the complete remission rate of BTK inhibitor refractory MCL patients with ixazomib and rituximab at 16 weeks of therapy. Complete remission at 16 weeks was measured by PET/CT or CT imaging using Lugano Criteria 2014. |
| Secondary | Overall Response Rate at 16 Weeks | 16 weeks | Evaluate the overall response rate (ORR) assessed by Lugano criteria (2014) |
| Secondary | Progression Free Survival (PFS) and Overall Survival (OS) | 16 weeks | Evaluate progression free survival and overall survival |
| Secondary | Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks. | Tolerability of study drug at weeks 8, 16, 28, 42, and 56 using CTCAE v4.0 Toxicities or Adverse Events (grade 3 and up) were measured using CTCAE v 4.0 to determine the tolerability of ixazomib. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Remission Rate at 16 Weeks | 16 weeks | All endpoints will be measured on patients that received at least one dose of the study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate at 16 Weeks | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival (PFS) and Overall Survival (OS) | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | time of first dose of ixazomib through 30 days after the last dose of ixazomib was administered, up to 140 weeks. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Remission Rate at 16 Weeks | Study Drug | 3 | Participants | ||
| Overall Response Rate at 16 Weeks | Study Drug | 3 | Participants | ||
| Progression Free Survival (PFS) and Overall Survival (OS) | Study Drug | Overall survival (OS) | 3 | Participants | |
| Progression Free Survival (PFS) and Overall Survival (OS) | Study Drug | Complete Metabolic Response (CMR) | 2 | Participants | |
| Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | Study Drug | Week 8 | 0 | Participants | |
| Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | Study Drug | Week 16 | 0 | Participants | |
| Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | Study Drug | Week 28 | 0 | Participants | |
| Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | Study Drug | Week 42 | 0 | Participants | |
| Tolerability of Study Drug at Weeks 8, 16, 28, 42, and 56 | Study Drug | Week 56 | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Drug | 3 | |
| Overall Study | COMPLETED | Study Drug | 2 | |
| Overall Study | NOT COMPLETED | Study Drug | 1 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Study Drug | 2 | 3 | 2 |
| other | Constipation | Gastrointestinal disorders | Study Drug | 1 | 3 | 1 |
| other | Abdominal distention | Gastrointestinal disorders | Study Drug | 1 | 3 | 1 |
| other | Urinary tract infection | Renal and urinary disorders | Study Drug | 1 | 3 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Study Drug | 2 | 3 | 3 |
| other | Insomnia | General disorders | Study Drug | 1 | 3 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Study Drug | 1 | 3 | 1 |
| other | Edema limbs | General disorders | Study Drug | 2 | 3 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Study Drug | 1 | 3 | 1 |
| other | Fatigue | General disorders | Study Drug | 2 | 3 | 2 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Drug | 0 | 3 |
| Total, other adverse events | Study Drug | 3 | 3 |
| Total, serious adverse events | Study Drug | 1 | 3 |
Source ClinicalTrials.gov
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
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/NCT04047797
GET https://conductscience.org/api/trials/v1/NCT04047797/registered