Trial · NCT01611259
Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
NCT01611259, Phase 2, Completed, Arbeitsgemeinschaft medikamentoese Tumortherapie; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue. Trials, record NCT01611259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01611259
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab Plus Lenalidomide in Patients With Mucosa Associated Lymphoid Tissue
- NCT number
- NCT01611259
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Conditions
- Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
- Interventions
- Rituximab and Lenalidomide
- First posted
- 2012-06-04
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | 40 weeks | The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of \< 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy. |
| Secondary | Number and Severity of Adverse Events | From treatment start until 28 days after last study treatment; expected study duration 24 months | Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population |
| Secondary | Influence of Rituximab Plus Lenalidomide on T-cell Subsets | Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 | T-cell subsets will be evaluated from EDTA blood in a central lab |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | 40 weeks | 48 patients were included into safety assessment, two of them received treatment but no efficacy assessment was available. Therefore, these two patients were neither included into Intention-to-treat nor Per-protocol efficacy analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Severity of Adverse Events | From treatment start until 28 days after last study treatment; expected study duration 24 months | |||
| SECONDARY | Influence of Rituximab Plus Lenalidomide on T-cell Subsets | Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5 |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | Rituximab and Lenalidomide | CR | 25 | Participants | |
| Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | Rituximab and Lenalidomide | PR or SD | 20 | Participants | |
| Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease | Rituximab and Lenalidomide | PD | 1 | 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 | Rituximab and Lenalidomide | 48 | |
| Overall Study | COMPLETED | Rituximab and Lenalidomide | 34 | |
| Overall Study | NOT COMPLETED | Rituximab and Lenalidomide | 14 |
Source ClinicalTrials.gov
Adverse events67
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 | Leucocyte count | Blood and lymphatic system disorders | Rituximab and Lenalidomide | 6 | 48 | 15 |
| other | Conjunctivitis | Eye disorders | Rituximab and Lenalidomide | 2 | 48 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | Rituximab and Lenalidomide | 2 | 48 | 2 |
| other | Constipation | Gastrointestinal disorders | Rituximab and Lenalidomide | 10 | 48 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab and Lenalidomide | 9 | 48 | 16 |
| other | Dry mouth | Gastrointestinal disorders | Rituximab and Lenalidomide | 4 | 48 | 5 |
| other | Dysgeusia | Gastrointestinal disorders | Rituximab and Lenalidomide | 3 | 48 | 3 |
| other | Dyspepsia | Gastrointestinal disorders | Rituximab and Lenalidomide | 3 | 48 | 4 |
| other | Gastroenteritis | Gastrointestinal disorders | Rituximab and Lenalidomide | 2 | 48 | 2 |
| other | Gastrointestinal pain | Gastrointestinal disorders | Rituximab and Lenalidomide | 3 | 48 | 3 |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab and Lenalidomide | ||
| Total, other adverse events | Rituximab and Lenalidomide | 47 | 48 |
| Total, serious adverse events | Rituximab and Lenalidomide | 18 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27879257 | RESULT |
Source PubMed
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/NCT01611259
GET https://conductscience.org/api/trials/v1/NCT01611259/events?page=2