Trial Outcomes & Findings for GIMEMA CLL0809 Study (BendOfa) (NCT NCT01244451)
NCT ID: NCT01244451
Last Updated: 2019-01-25
Results Overview
Patients response to treatment will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.
COMPLETED
PHASE2
49 participants
After 8 months from therapy start (6 months of treatment plus 2 months from the last course to response evaluation)
2019-01-25
Participant Flow
Participant milestones
| Measure |
Bendofa
Bendamustine + Ofatumumab
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GIMEMA CLL0809 Study (BendOfa)
Baseline characteristics by cohort
| Measure |
Bendofa
n=49 Participants
Bendamustine + Ofatumumab
|
|---|---|
|
Age, Continuous
|
65.85 Years
n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
49 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: After 8 months from therapy start (6 months of treatment plus 2 months from the last course to response evaluation)Patients response to treatment will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.
Outcome measures
| Measure |
Bendofa
n=44 Participants
Bendamustine + Ofatumumab
|
|---|---|
|
Number of Participants Contributing to the Overall Response Rate
|
34 participants
|
SECONDARY outcome
Timeframe: At 44 months from treatment start.Population: Number of patients experiencing 3 or \>3 Adverse Events (AEs) (both hematological and not hematological)
Number of patients experiencing 3 or \>3 AEs (both hematological and not hematological)
Outcome measures
| Measure |
Bendofa
n=49 Participants
Bendamustine + Ofatumumab
|
|---|---|
|
Toxicity According to CTCAE Version 4.0
|
47 participants
|
SECONDARY outcome
Timeframe: Up to 32 months: from the date of first BendOfa treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first.Patients still alive and known to be progression-free will be censored at the moment of last follow-up. Patients disease progression will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy and radiographic evaluation according to the revised IWCLL 2008 criteria.
Outcome measures
| Measure |
Bendofa
n=49 Participants
Bendamustine + Ofatumumab
|
|---|---|
|
Progression Free Survival
|
49 Participants
|
SECONDARY outcome
Timeframe: At 44 months from treatment start.Patients still alive will be censored at the moment of last follow-up.
Outcome measures
| Measure |
Bendofa
n=47 Participants
Bendamustine + Ofatumumab
|
|---|---|
|
Overall Survival
|
38 participants
|
Adverse Events
Study Group
Serious adverse events
| Measure |
Study Group
n=49 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.8%
20/49
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
44.9%
22/49
|
|
Blood and lymphatic system disorders
Autoimmune hemolytic anemia
|
4.1%
2/49
|
|
Blood and lymphatic system disorders
Neutropenia
|
79.6%
39/49
|
Other adverse events
| Measure |
Study Group
n=49 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49
|
|
Blood and lymphatic system disorders
Allergic dermatitis
|
2.0%
1/49
|
|
Blood and lymphatic system disorders
Allergic reaction
|
2.0%
1/49
|
|
Cardiac disorders
Arrhythmia
|
2.0%
1/49
|
|
General disorders
Cough
|
2.0%
1/49
|
|
General disorders
Dyspnoea
|
2.0%
1/49
|
|
General disorders
Fatigue
|
4.1%
2/49
|
|
General disorders
Gastrointestinal hemorrhage
|
2.0%
1/49
|
|
General disorders
Hypotension
|
4.1%
2/49
|
|
General disorders
Nausea
|
4.1%
2/49
|
|
General disorders
Other toxicity
|
6.1%
3/49
|
|
General disorders
Rash
|
4.1%
2/49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs of participating centres may disclose their centre's results only after the main study publication has been released, so that a single centre experience can be compared to the study overall results and give a more appropriate view of the study.
- Publication restrictions are in place
Restriction type: OTHER