NCT02561273 · OUTCOME
Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)
Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma · Source last updated 2023-12-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 6 cycles of treatment (approximately 5 months)
What was measured
Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized.
Analysis population: Toxicity was measured for all subjects dosed during Phase 1 of the study. 10 mg and 15 mg dose levels.
Groups in this outcome
10 mg Lenalidomide Participants
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.
15 mg Lenalidomide Participants
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.
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 |
|---|
| 10 mg Lenalidomide Participants | 8 |
|---|
| 15 mg Lenalidomide Participants | 4 |
|---|
Reported measurements
grade 3,4 neutropenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 anemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 thrombocytopenia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3,4 neutropenia fever
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 diarrhea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 hyperglycemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 hypokalemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 hypotension
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 hyperbilirubinemia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3, 4 mucositis
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3,4 nausea
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
grade 3,4 vomiting
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| 10 mg Lenalidomide Participants | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| 15 mg Lenalidomide Participants | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- title
- grade 3,4 neutropenia
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- title
- grade 3, 4 anemia
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- grade 3, 4 thrombocytopenia
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- title
- grade 3,4 neutropenia fever
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- grade 3, 4 diarrhea
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- grade 3, 4 hyperglycemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- grade 3, 4 hypokalemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- grade 3, 4 hypotension
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- grade 3, 4 hyperbilirubinemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- grade 3, 4 mucositis
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- grade 3,4 nausea
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- grade 3,4 vomiting
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized.
- 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.
- id
- OG000
- title
- 10 mg Lenalidomide Participants
- 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.
- id
- OG001
- title
- 15 mg Lenalidomide Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Toxicity was measured for all subjects dosed during Phase 1 of the study. 10 mg and 15 mg dose levels.
- reporting Status
- POSTED
- time Frame
- Up to 6 cycles of treatment (approximately 5 months)
- title
- Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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