Trial Outcomes & Findings for Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL (NCT NCT01241734)
NCT ID: NCT01241734
Last Updated: 2023-09-14
Results Overview
Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with rituximab, Ifosfamide, etoposide, and carboplatin (RICE) for the treatment of DLBCL patients in first relapse by incidence of dose-limiting toxicity (DLT) for Stage I Patients Only
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Cycle 1 of Treatment (28 Days)
Results posted on
2023-09-14
Participant Flow
2010-2015
Participant milestones
| Measure |
Stage I, Cohort 1
RICE + Lenalidomide 10mg days 1-7
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
5
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
Baseline characteristics by cohort
| Measure |
Stage I, Cohort 1
n=3 Participants
RICE + Lenalidomide 10mg days 1-7
|
Stage I, Cohort 2
n=4 Participants
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
n=3 Participants
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
n=3 Participants
RICE + Lenalidomide 25mg days 1-7
|
Stage II
n=5 Participants
RICE + Lenalidomide 25mg (MTD) days 1-7
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=3 Participants
|
60 years
n=4 Participants
|
64 years
n=3 Participants
|
63 years
n=3 Participants
|
51 years
n=5 Participants
|
61.5 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
0 Participants
n=4 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
1 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
0 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
0 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
3 Participants
n=16 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
4 Participants
n=4 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
2 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
3 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
3 Participants
n=3 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
13 Participants
n=16 Participants • A portion of the Stage II patients were enrolled at an external site and some demographic details of these patients are no longer available.
|
PRIMARY outcome
Timeframe: Cycle 1 of Treatment (28 Days)Determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with rituximab, Ifosfamide, etoposide, and carboplatin (RICE) for the treatment of DLBCL patients in first relapse by incidence of dose-limiting toxicity (DLT) for Stage I Patients Only
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
n=13 Participants
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability
|
25 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: After 2 Cycles of Treatment (28 Day Cycles)Population: Only patients enrolled in Stage II analyzed
Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage II
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
n=3 Participants
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage II - Overall Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: After 2 Cycles of Treatment (28 Day Cycles)Population: No Stage III Participants Enrolled
Rate of overall response by incidence of Complete Response, Partial Response, and Stable Disease per Modified International Working Group (IWG) response criteria for patients enrolled in Stage III
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 of Treatment (28 Days)Population: Rate of DLTs occurred in Stage I Participants
Incidence of DLT in patients enrolled in stage I for determination of MTD
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
n=3 Participants
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
n=4 Participants
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
n=3 Participants
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
n=3 Participants
RICE + Lenalidomide 25mg days 1-7
|
Stage II
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage I - Dose Limiting Toxicity Incidence Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 YearPopulation: Only patients enrolled in Stage II analyzed
Rate of Progression Free Survival (PFS) at 1 Year of patients enrolled in stage II
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
n=3 Participants
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage II - 1 Year Progression Free Survival (PFS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 YearsPopulation: Only patients enrolled in Stage II analyzed
Rate of Progression Free Survival (PFS) at 1 Year of patients enrolled in stage II
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
n=3 Participants
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage II - 2 Year Progression Free Survival (PFS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1 YearPopulation: Only patients enrolled in stage II analyzed
1 Year Overall Survival (OS) of patients enrolled in stage II
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
n=2 Participants
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage II - 1 Year Overall Survival (OS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only patients enrolled in stage II analyzed
2 Year Overall Survival (OS) of patients enrolled in stage II
Outcome measures
| Measure |
Revlimid (Lenalidomide) in Combination
Study of Lenalidomide in Combination with Rituximab, Ifosphamide, Etoposide, and Carboplatin (RICE-R) as Salvage Therapy with Single Agent Lenalidomide as Maintenance Therapy Post-Autologous Stem Cell Transplantation
Revlimid: Stage I:
Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
Stage II:
RICE + Lenalidomide at the MTD days 1-7
Stage III:
Lenalidomide 25mg days 1-21 every 28 days
|
Stage I, Cohort 2
RICE + Lenalidomide 15mg days 1-7
|
Stage I, Cohort 3
RICE + Lenalidomide 20mg days 1-7
|
Stage I, Cohort 4
RICE + Lenalidomide 25mg days 1-7
|
Stage II
n=2 Participants
RICE + Lenalidomide 25mg (MTD) days 1-7
|
|---|---|---|---|---|---|
|
Stage II - 2 Year Overall Survival (OS)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 Years Post TransplantPopulation: No Stage III Participants Enrolled
Rate of Progression Free Survival (PFS) 2 years post Transplant
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 Years Post TransplantPopulation: No Stage III Participants Enrolled
2 Year Overall Survival (OS) of patients enrolled in stage III
Outcome measures
Outcome data not reported
Adverse Events
RICE + Lenalidomide
Serious events: 8 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
RICE + Lenalidomide
n=16 participants at risk
RICE + Lenalidomide days 1-7
|
|---|---|
|
Infections and infestations
RSV Infection
|
6.2%
1/16 • Number of events 1
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
6.2%
1/16 • Number of events 1
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Blood and lymphatic system disorders
Secondary Primary Malignancy (+MDS)
|
6.2%
1/16 • Number of events 1
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Gastrointestinal disorders
Infectious Enterocolitis
|
6.2%
1/16 • Number of events 1
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
1/16 • Number of events 2
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Investigations
Fever (absence of neutropenia)
|
12.5%
2/16 • Number of events 2
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Infections and infestations
Sepsis (Gram Positive)
|
6.2%
1/16 • Number of events 1
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
Other adverse events
| Measure |
RICE + Lenalidomide
n=16 participants at risk
RICE + Lenalidomide days 1-7
|
|---|---|
|
Nervous system disorders
Neuropathy
|
12.5%
2/16
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
General disorders
Fatigue
|
12.5%
2/16
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Blood and lymphatic system disorders
Anemia
|
93.8%
15/16
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
87.5%
14/16
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.5%
10/16
Adverse Events were collected irrespective of dose level and therefore cannot be reported by dose level
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place