NCT01996865 · OUTCOME
Participants With Grade 3 or Grade 4 Hematology Parameters
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. · Source last updated 2025-07-10
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
- From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
What was measured
Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of induction therapy or before the first dose date of maintenance therapy, whichever is earlier. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.
Analysis population: All treated participants
Groups in this outcome
Induction Period: Lenalidomide + Rituximab
Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
Arm A: Lenalidomide + Rituximab
Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
Arm B: Rituximab
Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
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 |
|---|
| Induction Period: Lenalidomide + Rituximab | 500 |
|---|
| Arm A: Lenalidomide + Rituximab | 134 |
|---|
| Arm B: Rituximab | 132 |
|---|
Reported measurements
Anemia - Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukopenia - Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 101 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Thrombocytopenia - Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutropenia - Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 103 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphopenia - Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 126 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Anemia - Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukopenia - Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Thrombocytopenia - Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutropenia - Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 94 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphopenia - Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Period: Lenalidomide + Rituximab | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm A: Lenalidomide + Rituximab | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Rituximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- title
- Anemia - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 6
- title
- Leukopenia - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- title
- Thrombocytopenia - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 10
- title
- Neutropenia - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 21
- title
- Lymphopenia - Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Anemia - Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- title
- Leukopenia - Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Thrombocytopenia - Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 6
- title
- Neutropenia - Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 2
- title
- Lymphopenia - Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 500
- group Id
- OG001
- value
- 134
- group Id
- OG002
- value
- 132
- units
- Participants
- description
- Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of induction therapy or before the first dose date of maintenance therapy, whichever is earlier. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.
- groups
- description
- Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
- id
- OG000
- title
- Induction Period: Lenalidomide + Rituximab
- description
- Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
- id
- OG001
- title
- Arm A: Lenalidomide + Rituximab
- description
- Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
- id
- OG002
- title
- Arm B: Rituximab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)
- title
- Participants With Grade 3 or Grade 4 Hematology Parameters
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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