Comparison · NCT01121757-440fd5d7
1a-Azacitidine Followed by Lenalidomide vs 1b-Lenalidomide Followed by Azacitidine: Overall Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 1a-Azacitidine Followed by Lenalidomide vs 1b-Lenalidomide Followed by Azacitidine: Overall Response. Trial comparisons, record NCT01121757-440fd5d7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01121757-440fd5d7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.5 | 0.15 | 0.85 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0.5 | -0.367 | 0.85 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on 1a-Azacitidine Followed by Lenalidomide than on 1b-Lenalidomide Followed by Azacitidine | 2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 1a-Azacitidine Followed by Lenalidomide | Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better. | 2 | 4 | OG000 |
| Group 2 | 1b-Lenalidomide Followed by Azacitidine | Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better. | 0 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Overall Response
- Description
Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam.
- Time frame
- Response will be assessed after at least 4 months on second drug.
- Population
- Everyone who started the second drug regimen
Source ClinicalTrials.gov
Trial
- Title
- Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma
- NCT number
- NCT01121757
- Phases
- PHASE2
- Conditions
- Follicular Lymphoma, Marginal Zone Lymphoma
- Interventions
- azacitidine, lenalidomide
- Lead sponsor
- Duke University
- Results first posted
- 2015-05-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01121757?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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