Trial Outcomes & Findings for Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma (NCT NCT00799513)
NCT ID: NCT00799513
Last Updated: 2024-04-10
Results Overview
It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
1-year
Results posted on
2024-04-10
Participant Flow
Participant milestones
| Measure |
Lenalidomide
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lenalidomide
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=46 Participants
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=46 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=46 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=46 Participants
|
|
Age, Continuous
|
72 years
n=46 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=46 Participants
|
|
Region of Enrollment
Italy
|
46 Participants
n=46 Participants
|
|
Relapse Status
First
|
33 Participants
n=46 Participants
|
|
Relapse Status
Second
|
13 Participants
n=46 Participants
|
|
Previous Lines for Diffuse Large B Cell Lymphoma (DLBCL) treatment
Rituximab Cyclophosphamide Hydroxydaunorubicin Oncovin Prednisone.(R-CHOP)
|
38 Participants
n=46 Participants
|
|
Previous Lines for Diffuse Large B Cell Lymphoma (DLBCL) treatment
Rituximab+methotrexate+Adriamycin+cyclophosphamide+Oncovin+prednisone+bleomycin(R-VACOP-MACOP-B
|
8 Participants
n=46 Participants
|
|
Previous ASCT (Autologous Stem-Cell Transplantation)
|
6 Participants
n=46 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score >=1
|
18 Participants
n=46 Participants
|
|
International Prognostic Index
Low- 5-year survival of 73%
|
8 Participants
n=46 Participants
|
|
International Prognostic Index
Low-Intermediate- 5-year survival of 51%
|
21 Participants
n=46 Participants
|
|
International Prognostic Index
High-Intermediate- 5-year survival of 43%
|
12 Participants
n=46 Participants
|
|
International Prognostic Index
High- 5-year survival of 26%
|
5 Participants
n=46 Participants
|
|
Advanced stage of disease
|
35 Participants
n=46 Participants
|
|
Increased LDH (lactate dehydrogenase) serum level
|
21 Participants
n=46 Participants
|
|
Systemic symptoms (B status)
|
5 Participants
n=46 Participants
|
|
Extranodal disease
|
29 Participants
n=46 Participants
|
|
Bone marrow infiltration
|
6 Participants
n=46 Participants
|
|
Hepatitis viral infection
Hepatitis B Virus
|
7 Participants
n=46 Participants
|
|
Hepatitis viral infection
Hepatitis C Virus
|
2 Participants
n=46 Participants
|
|
Hepatitis viral infection
Both
|
3 Participants
n=46 Participants
|
|
Hepatitis viral infection
None
|
34 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
High-dose Cytarabine-based: DHAP
|
10 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
High-dose Cytarabine-based:DHAOx
|
10 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
High-dose Cytarabine-based: ESHAP
|
3 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
High-dose Ifosfamide-based: ICE
|
8 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
Anthracycline-based: CHOP
|
6 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
Bendamustine
|
5 Participants
n=46 Participants
|
|
Salvage chemoimmunotherapy
Gemcitabine-oxaliplatin
|
4 Participants
n=46 Participants
|
|
Response at time of trial registration
Complete remission
|
26 Participants
n=46 Participants
|
|
Response at time of trial registration
Partial remission
|
20 Participants
n=46 Participants
|
PRIMARY outcome
Timeframe: 1-yearIt is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored.
Outcome measures
| Measure |
Lenalidomide
n=46 Participants
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
1-year Progression-free Survival
|
31 Participants
|
SECONDARY outcome
Timeframe: 5 yearsSecondary measures to describe long term outcome of treatment -Progression free survival It is defined as the number of participants, on a 5 yrs follow up, free from disease progression
Outcome measures
| Measure |
Lenalidomide
n=46 Participants
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Progression Free Survival
|
25 Participants
|
SECONDARY outcome
Timeframe: 5 yearsProgression It is defined as the number of participants with disease recurrence observed on a 5 yrs follow up.
Outcome measures
| Measure |
Lenalidomide
n=46 Participants
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Progression
|
21 Participants
|
SECONDARY outcome
Timeframe: 5 yearsSecondary measures to describe long term outcome of treatment * Duration of response It is defined as the number of participants experiencing a PFS (Progression Free Survival) from study therapy longer than previous line of treatment
Outcome measures
| Measure |
Lenalidomide
n=46 Participants
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Duration of Response
|
29 Participants
|
SECONDARY outcome
Timeframe: 5 yearsSecondary measures to describe long term outcome of treatment -Overall survival It is defined as the number of participants alive at 5ys from enrolment (death for any cause). Patients alive at last follow-up will be censored.
Outcome measures
| Measure |
Lenalidomide
n=46 Participants
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Overall Survival
|
26 Participants
|
Adverse Events
Lenalidomide
Serious events: 12 serious events
Other events: 7 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Lenalidomide
n=48 participants at risk
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.4%
5/48 • Number of events 5 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Gastrointestinal disorders
diarrhea
|
4.2%
2/48 • Number of events 2 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Gastrointestinal disorders
melena
|
2.1%
1/48 • Number of events 1 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Vascular disorders
stroke
|
2.1%
1/48 • Number of events 1 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Gastrointestinal disorders
vomiting
|
2.1%
1/48 • Number of events 1 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Infections and infestations
Herpes voster virus
|
2.1%
1/48 • Number of events 1 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Gastrointestinal disorders
intestinal infraction
|
2.1%
1/48 • Number of events 1 • 5 years
Definition per International Conference on Harmonization (ICH)
|
|
Infections and infestations
meningitis
|
2.1%
1/48 • Number of events 1 • 5 years
Definition per International Conference on Harmonization (ICH)
|
Other adverse events
| Measure |
Lenalidomide
n=48 participants at risk
single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia G3+
|
14.6%
7/48 • Number of events 12 • 5 years
Definition per International Conference on Harmonization (ICH)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place