TriangleNCT02561273 · OUTCOME
Complete Response Rate (Phase II)
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
- 95% Confidence Interval
- Time frame
- Up to the completion of course 6 (18 weeks)
What was measured
A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner.
Analysis population: Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.
Groups in this outcome
Treatment (Combination Chemotherapy, Lenalidomide)
Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood stem cell transplant Prednisone: Given PO Vincristine Sulfate: Given IV
| Group | Source count |
|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 49 | Not reported | 33 | 64 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33
- upper Limit
- 64
- value
- 49
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous stem cell transplant Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO Peripheral Blood Stem Cell Transplantation: Undergo peripheral blood stem cell transplant Prednisone: Given PO Vincristine Sulfate: Given IV
- id
- OG000
- title
- Treatment (Combination Chemotherapy, Lenalidomide)
- param Type
- NUMBER
- population Description
- Assessment based on phase II patients given the maximum tolerated dose level (10 mg) as the Intent to treat (ITT) group of subjects. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.
- reporting Status
- POSTED
- time Frame
- Up to the completion of course 6 (18 weeks)
- title
- Complete Response Rate (Phase II)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice