Trial Outcomes & Findings for Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL) (NCT NCT01403246)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

At maximum 8 months from induction therapy start

Results posted on

2019-02-12

Participant milestones
Measure	Lenalidomide and Chlorambucil
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort
Measure	Study Group n=9 Participants
Age, Customized	72 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Italy	9 participants n=5 Participants

Timeframe: At maximum 8 months from induction therapy start

Outcome measures
Measure	Study Group n=9 Participants
Number of Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil.	0 Toxic events

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Study Group n=9 participants at risk
Blood and lymphatic system disorders Neutropenia	22.2% 2/9 • Number of events 5 • 3 years and 3 months The adverse events in the present study report have been classified according to the CTCAE grading. These are included under the Serious Adverse Events, although the fields in the form do not allow to specify grading.
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Number of events 2 • 3 years and 3 months The adverse events in the present study report have been classified according to the CTCAE grading. These are included under the Serious Adverse Events, although the fields in the form do not allow to specify grading.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 3/9 • Number of events 6 • 3 years and 3 months The adverse events in the present study report have been classified according to the CTCAE grading. These are included under the Serious Adverse Events, although the fields in the form do not allow to specify grading.

Adverse event data not reported

GIMEMA

Phone: +393203671224

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