Comparison · NCT01319981-52fb3fac
Hyper-CMAD + Rituximab vs Hyper-CMAD: Number of Patients With Complete Remission at One Year
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Hyper-CMAD + Rituximab vs Hyper-CMAD: Number of Patients With Complete Remission at One Year. Trial comparisons, record NCT01319981-52fb3fac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01319981-52fb3fac
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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 | 0.8 | 0.548 | 0.93 | wilson | |
| Risk in group 2 | 0.813 | 0.57 | 0.934 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0125 | -0.292 | 0.263 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.985 | 0.697 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 0.923 | 0.155 | 5.49 | log | |
| Number needed to treat, for one fewer participant with the outcome on Hyper-CMAD + Rituximab than on Hyper-CMAD | 80 | 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 | Hyper-CMAD + Rituximab | Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 1 \& 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 \& 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.~Rituximab: CD20-positive patients, 375 mg/m2 by vein on days 1 and 8 for Courses 1 and 3; and days 1 and 8 of Courses 2 and 4.~Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).~Cyclophosphamide: 300 mg/m2 by vein, 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7~Doxorubicin: 50 mg/m2 by vein, 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7~Mesna: 600 mg/m2 by vein continuous daily for 24 hours days 1-3 for courses 1, 3, 5, 7~VSLI: 2.0 mg/m2 by vein on days 1 and 8 for courses 1, 3, 5, 7~G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.~Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.~Dexamethasone: 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7 | 12 | 15 | OG000 |
| Group 2 | Hyper-CMAD | Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 \& 8 Courses 2 \& 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.~Rituximab: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.~Imatinib: 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).~VSLI: 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7~Solu-Medrol: 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.~Methotrexate: 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.~Ara-C: 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.~G-CSF: 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10\^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10\^9/L by day 21.~Pegfilgrastim: 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy. | 13 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients With Complete Remission at One Year
- Description
The complete remission (CR) is the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine. CR was defined as the presence of \</=5% blasts in the bone marrow, with \>1x10\^9/L neutrophils, \>100x10\^9/L platelets in the perpherial blood, and no extramedullary disease.
- Time frame
- 1 year
- Population
Source ClinicalTrials.gov
Trial
- Title
- Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia
- NCT number
- NCT01319981
- Phases
- PHASE2
- Conditions
- Leukemia
- Interventions
- Rituximab, Imatinib, Cyclophosphamide, Doxorubicin, Mesna, VSLI, Solu-Medrol, Methotrexate, Ara-C, G-CSF, Pegfilgrastim, Dexamethasone
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2022-09-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01319981?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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