Comparison · NCT02655601-9ff65723
Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 vs Arm B: Ph 2 Radiation Therapy and TMZ: Phase 2: Protection of Bone Marrow Against Chemotherapy-Induced Thrombocytopenia
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 vs Arm B: Ph 2 Radiation Therapy and TMZ: Phase 2: Protection of Bone Marrow Against Chemotherapy-Induced Thrombocytopenia. Trial comparisons, record NCT02655601-9ff65723. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02655601-9ff65723
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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 | 0.0128 | 0.00227 | 0.0691 | wilson | |
| Risk in group 2 | 0.0282 | 0.00776 | 0.097 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0153 | -0.085 | 0.0445 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.455 | 0.0422 | 4.91 | log | |
| Odds ratio, group 1 over group 2 | 0.448 | 0.0397 | 5.05 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 than on Arm B: Ph 2 Radiation Therapy and TMZ | 65.2 | 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 | Arm A: Ph 2 Radiation Therapy, TMZ and BMX-001 | Patients received standard of care radiation therapy plus temozolomide (TMZ). BMX-001 was given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects were eligible to receive BMX-001 in this phase. | 1 | 78 | OG000 |
| Group 2 | Arm B: Ph 2 Radiation Therapy and TMZ | In this arm, one-half of the study subjects did not receive BMX-001 but underwent all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects were eligible for inclusion in this study arm. | 2 | 71 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Phase 2: Protection of Bone Marrow Against Chemotherapy-Induced Thrombocytopenia
- Description
This was not a secondary outcome in Phase 1 and therefore only applies to Phase 2. The proportion of patients who experience grade 3 or 4 thrombocytopenia during concurrent temozolomide and radiation will be recorded within each treatment group. The proportion of patients who experience a platelet count less than 100K during concurrent temozolomide and radiation will also be recorded within each treatment group. For both endpoints described above, a chi-square or Fisher's exact test was conducted to compare the prevalence of such thrombocytopenia observed in patients with and without BMX-001.
- Time frame
- Approximately 12 weeks (from Baseline to 30 days post completion of treatment)
- Population
For this endpoint to have relevance, a patient must have received some treatment with temozolomide and radiation in either Arm A or B. Analyses suggest that 78 patients in Arm A and 71 patients in Arm B received at least some form of protocol treatment.
Source ClinicalTrials.gov
Trial
- Title
- Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
- NCT number
- NCT02655601
- Phases
- PHASE1, PHASE2
- Conditions
- High Grade Glioma, Astrocytoma, Grade III, Glioblastoma
- Interventions
- BMX-001, Radiation Therapy, Temozolomide
- Lead sponsor
- BioMimetix JV, LLC
- Results first posted
- 2025-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02655601?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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