TriangleNCT04409639 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From the start of study treatment to the last dose of study treatment, up to 20 months
What was measured
To assess the efficacy of cobimetinib in patients with newly diagnosed and HMA- refractory chronic myelomonocytic leukemia (CMML). Overall response rate (ORR) is defined as the proportion of patients achieving complete remission, complete cytogenetic remission, partial remission, marrow response, and clinical benefit according to the 2015 MDS/MPN-IWG criteria. This was assessed from the dose of study medication to the decision to end treatment, up to 20 months.
Analysis population: The EOT disease assessment was not done for one patient in error. One patient was not able to travel to the study site for the EOT disease assessment due to illness.
Groups in this outcome
HMA Refractory
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
Newly Diagnosed
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
| Group | Source count |
|---|---|
| HMA Refractory | 4 |
| Newly Diagnosed | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HMA Refractory | 25 | Not reported | 1.27 | 52.71 | Not reported |
| Newly Diagnosed | 38 | Not reported | 11.11 | 59.97 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.27
- upper Limit
- 52.71
- value
- 25
- group Id
- OG001
- lower Limit
- 11.11
- upper Limit
- 59.97
- value
- 38
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- To assess the efficacy of cobimetinib in patients with newly diagnosed and HMA- refractory chronic myelomonocytic leukemia (CMML). Overall response rate (ORR) is defined as the proportion of patients achieving complete remission, complete cytogenetic remission, partial remission, marrow response, and clinical benefit according to the 2015 MDS/MPN-IWG criteria. This was assessed from the dose of study medication to the decision to end treatment, up to 20 months.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
- id
- OG000
- title
- HMA Refractory
- description
- Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
- id
- OG001
- title
- Newly Diagnosed
- param Type
- NUMBER
- population Description
- The EOT disease assessment was not done for one patient in error. One patient was not able to travel to the study site for the EOT disease assessment due to illness.
- reporting Status
- POSTED
- time Frame
- From the start of study treatment to the last dose of study treatment, up to 20 months
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice