Trial Outcomes & Findings for A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma (NCT NCT02529852)
NCT ID: NCT02529852
Last Updated: 2024-09-19
Results Overview
Assessing the participant's characteristics and clinical outcomes after 2 cycles/42 days of LO-CHOP. The safety evaluation is defined as the lack of any grade ≥3 nonhematologic toxicity unmanageable with aggressive supportive care or toxicity, resulting in a delay of over 7 days of cycle 2.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
59 participants
Primary outcome timeframe
up to 42 days
Results posted on
2024-09-19
Participant Flow
Fifty-three participants were enrolled, 6 in the phase 1b portion and 47 in the phase 2 portion. Participants started treatment between 12 November 2015 and 30 March 2017.
Participants were required to have adequate organ and bone marrow function. Participants were ineligible if they were pregnant or nursing women, had a prior diagnosis of low-grade lymphoma, had central nervous system involvement, active HIV infection, active Hepatitis B or C infection, or were unwilling to take aspirin for venous thrombosis prophylaxis. There was no de-escalation phase on this study.
Participant milestones
| Measure |
Phase 1b/Phase 2
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
Phase 1b
|
6
|
|
Overall Study
Phase 2
|
47
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Phase 1b/Phase 2
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Phase1b/Phase 2
n=53 Participants
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 42 daysPopulation: 2 patients were inevaluable due to consent withdrawal.
Assessing the participant's characteristics and clinical outcomes after 2 cycles/42 days of LO-CHOP. The safety evaluation is defined as the lack of any grade ≥3 nonhematologic toxicity unmanageable with aggressive supportive care or toxicity, resulting in a delay of over 7 days of cycle 2.
Outcome measures
| Measure |
Phase1b/Phase 2
n=53 Participants
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles
|
|---|---|
|
Safety of LO-CHOP
Grade 3 to 4 AE
|
70 percentage of participants
|
|
Safety of LO-CHOP
DLTs
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 126 daysestimate overall survival
Outcome measures
| Measure |
Phase1b/Phase 2
n=53 Participants
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles
|
|---|---|
|
Overall Survival
|
91.3 percentage of participants
Interval 83.5 to 99.9
|
SECONDARY outcome
Timeframe: up to 4.5 yearsProgression free survival
Outcome measures
| Measure |
Phase1b/Phase 2
n=53 Participants
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles
|
|---|---|
|
Progression Free Survival
|
87.4 percentage of participants
Interval 78.4 to 97.5
|
Adverse Events
Phase1b/Phase2
Serious events: 21 serious events
Other events: 51 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Phase1b/Phase2
n=53 participants at risk
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
37.7%
20/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.0%
9/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
General disorders
Fatigue
|
13.2%
7/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.2%
7/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Infections and infestations
Infection
|
9.4%
5/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
General disorders
Pain
|
5.7%
3/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
1/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
Other adverse events
| Measure |
Phase1b/Phase2
n=53 participants at risk
Participants were treated with Lenalidomide 15 mg orally daily on days 1 through 14 of each 21-day cycle, Obinutuzumab 1000 mg intravenously on days 1, 8, and 15 of cycle 1 and day 1 only for all additional cycles, and standard CHOP (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 \[capped at 2.0 mg\], and prednisone 100 mg by mouth daily on days 1 through 5) starting on day 1 of all cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
39.6%
21/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.3%
15/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
General disorders
Fatigue
|
96.2%
51/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
13.2%
7/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Infections and infestations
Infection
|
22.6%
12/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
General disorders
Pain
|
34.0%
18/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Gastrointestinal disorders
Constipation
|
84.9%
45/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Gastrointestinal disorders
Nausea
|
71.7%
38/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Anemia
|
62.3%
33/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
41.5%
22/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Gastrointestinal disorders
Diarrhea
|
39.6%
21/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
|
Blood and lymphatic system disorders
Venous thromboembolism
|
7.5%
4/53 • up to 4.5 years
4 patients died when already off-study, these deaths were after disease progression.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place