Trial · NCT00210353
Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
NCT00210353, Phase 3, Completed, International Extranodal Lymphoma Study Group (IELSG); results first posted 2019-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma. Trials, record NCT00210353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00210353
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
- NCT number
- NCT00210353
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 454 participants, actual
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Conditions
- Lymphoma, Mucosa-Associated Lymphoid Tissue
- Interventions
- chlorambucil (drug), rituximab+chlorambucil, rituximab
- First posted
- 2005-09-21
- Last updated
- 2019-06-06
- Results first posted
- 2019-06-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free-survival (EFS) | 5 years | Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration |
| Secondary | Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | End of treatment (after 24 weeks of therapy) | Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response. Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). Partial response. Decrease by at least 50% in SPD of the six largest measurable lesions. It is not necessary for all lesions to have regressed to qualify for partial response, but no lesion should have progressed and no new lesion should appear. For primary gastric sites, response was based on GELA histologic grading system. |
| Secondary | Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | 5 years | Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response (CR). Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). |
| Secondary | Progression-free-survival (PFS) | 5 years | Percentage of patients without disease progression after 5 years from trial registration |
| Secondary | Overall Survival | 5 years | Percentage of patients alive after 5 years from trial registration |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free-survival (EFS) | 5 years | Evaluable patients | percentage of patients | NUMBER |
| SECONDARY | Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | End of treatment (after 24 weeks of therapy) | Evaluable patients | percentage of patients | NUMBER |
| SECONDARY | Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | 5 years | Evaluable patients | percentage of patients | NUMBER |
| SECONDARY | Progression-free-survival (PFS) | 5 years | Evaluable Patients | percentage of patients | NUMBER |
| SECONDARY | Overall Survival | 5 years | Evaluable Patients | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event-free-survival (EFS) | ARM A - Chlorambucil | 51 | 95% Confidence Interval 42 to 60 | percentage of patients | |
| Event-free-survival (EFS) | ARM B - Rituximab + Chlorambucil | 68 | 95% Confidence Interval 60 to 76 | percentage of patients | |
| Event-free-survival (EFS) | ARM C (Since April 2006) - Rituximab | 51 | 95% Confidence Interval 42 to 60 | percentage of patients | |
| Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | ARM A - Chlorambucil | 85.5 | 95% Confidence Interval 78.3 to 91.0 | percentage of patients | |
| Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | ARM B - Rituximab + Chlorambucil | 94.7 | 95% Confidence Interval 89.4 to 97.8 | percentage of patients | |
| Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment | ARM C (Since April 2006) - Rituximab | 78.3 | 95% Confidence Interval 70.4 to 84.8 | percentage of patients | |
| Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | ARM A - Chlorambucil | 70 | 95% Confidence Interval 60 to 78 | percentage of patients | |
| Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | ARM B - Rituximab + Chlorambucil | 79 | 95% Confidence Interval 71 to 85 | percentage of patients | |
| Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration | ARM C (Since April 2006) - Rituximab | 66 | 95% Confidence Interval 56 to 74 | percentage of patients | |
| Progression-free-survival (PFS) | ARM A - Chlorambucil | 59 | 95% Confidence Interval 50 to 68 | percentage of patients |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARM A - Chlorambucil | 151 | |
| Overall Study | STARTED | ARM B - Rituximab + Chlorambucil | 152 | |
| Overall Study | STARTED | ARM C (Since April 2006) - Rituximab | 151 | |
| Overall Study | COMPLETED | ARM A - Chlorambucil | 113 | |
| Overall Study | COMPLETED | ARM B - Rituximab + Chlorambucil | 107 | |
| Overall Study | COMPLETED | ARM C (Since April 2006) - Rituximab | 125 | |
| Overall Study | NOT COMPLETED | ARM A - Chlorambucil | 38 | |
| Overall Study | NOT COMPLETED | ARM B - Rituximab + Chlorambucil | 45 | |
| Overall Study | NOT COMPLETED | ARM C (Since April 2006) - Rituximab | 26 |
Source ClinicalTrials.gov
Adverse events111
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 | Fatigue | General disorders | ARM A | 16 | 131 | 16 |
| other | Fatigue | General disorders | ARM B | 13 | 132 | 13 |
| other | Fatigue | General disorders | ARM C (Since April 2006) | 16 | 138 | 16 |
| other | Pyrexia | General disorders | ARM A | 1 | 131 | 1 |
| other | Pyrexia | General disorders | ARM B | 6 | 132 | 6 |
| other | Pyrexia | General disorders | ARM C (Since April 2006) | 9 | 138 | 9 |
| other | Nausea | Gastrointestinal disorders | ARM A | 7 | 131 | 7 |
| other | Nausea | Gastrointestinal disorders | ARM B | 18 | 132 | 18 |
| other | Nausea | Gastrointestinal disorders | ARM C (Since April 2006) | 7 | 138 | 7 |
| other | Infection | Infections and infestations | ARM A | 17 | 131 | 17 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARM A | 20 | 131 |
| Total, all-cause mortality | ARM B | 25 | 132 |
| Total, all-cause mortality | ARM C (Since April 2006) | 13 | 138 |
| Total, other adverse events | ARM A | 42 | 131 |
| Total, other adverse events | ARM B | 77 | 132 |
| Total, other adverse events | ARM C (Since April 2006) | 59 | 138 |
| Total, serious adverse events | ARM A | 4 | 131 |
| Total, serious adverse events | ARM B | 20 | 132 |
| Total, serious adverse events | ARM C (Since April 2006) | 13 | 138 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00210353
GET https://conductscience.org/api/trials/v1/NCT00210353/events?page=2