NCT00211185 · OUTCOME
Overall Response in the Efficacy Analyzable (EA) Population
A Study of ONTAK and CHOP in Newly Diagnosed, Peripheral T-Cell Lymphoma · Source last updated 2020-03-18
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
- Not reported
- Time frame
- From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months
What was measured
Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.
Analysis population: EA population includes all participants who received at least 2 cycles of study drug treatment, were eligible to participate or ineligible with an exception granted by the principal investigator (PI), had bidimensional lesions at baseline, and had at least 1 disease response assessment form submitted following cycle 2.
Groups in this outcome
Denileukin Diftitox in Combination With CHOP
Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Denileukin Diftitox in Combination With CHOP | 37 |
|---|
Reported measurements
Confirmed complete response
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 67.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Unconfirmed complete response
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 5.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial response
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 13.5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable disease
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 8.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Disease progression
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 5.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Early death
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Inadequate assessment
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Denileukin Diftitox in Combination With CHOP | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Confirmed complete response
- title
- Unconfirmed complete response
- title
- Partial response
- title
- Stable disease
- title
- Disease progression
- title
- Early death
- title
- Inadequate assessment
- description
- Response rate was defined as the percentage of the EA population who achieved a CR, CRu, or PR. The International Working Group recommendations on non-Hodgkin's lymphoma response criteria were used to determine response to therapy. Largely, the protocol defined the response criteria as: 1) CR, loss of all detectable clinical and radiographic evidence of disease and disease-related symptoms if present before therapy; 2) CRu, CR with the caveats, response to therapy was accompanied with a 75% reduction in measurable lesion size and/or an indeterminate bone marrow biopsy (if initially positive); and 3) PR, less than or equal to 50% decrease in the sum of the measurements of tumor diameters, no increase in the size of other nodes, liver, or spleen, hepatic or spleen nodules regressed by at least 50%, and/or no new sites of disease.
- groups
- description
- Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
- id
- OG000
- title
- Denileukin Diftitox in Combination With CHOP
- param Type
- NUMBER
- population Description
- EA population includes all participants who received at least 2 cycles of study drug treatment, were eligible to participate or ineligible with an exception granted by the principal investigator (PI), had bidimensional lesions at baseline, and had at least 1 disease response assessment form submitted following cycle 2.
- reporting Status
- POSTED
- time Frame
- From the start of the treatment to the date of the participant's death assessed up to 5 years 9 months
- title
- Overall Response in the Efficacy Analyzable (EA) Population
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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