Trial Outcomes & Findings for Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL (NCT NCT01241786)

NCT ID: NCT01241786

Last Updated: 2022-07-20

Results Overview

the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 9 Months
• Results posted on: 2022-07-20

Participant Flow

A total of five subject participated in the trial.

A total of five patients were screened and consented for study and scheduled to start cycle 1

Participant milestones

Measure	Revlimid (Lenalidomide)and Vidaza (Azacitidine) Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Revlimid (Lenalidomide)and Vidaza (Azacitidine) Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL.
Overall Study Lack of Efficacy	5

Baseline Characteristics

Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL

Baseline characteristics by cohort

Measure	Revlamid + Vidaza n=5 Participants The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 9 Months

Population: Zero patients achieved a response to the combination

the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).

Outcome measures

Measure	Study Terminated n=5 Participants Study terminated - closed early
the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients	0 participants

SECONDARY outcome

Timeframe: 30 days after treatment completion (up to 10 Months)

Outcome measures

Measure	Study Terminated n=5 Participants Study terminated - closed early
Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine.	1 participants

SECONDARY outcome

Timeframe: 9 Months

Outcome measures

Measure	Study Terminated n=4 Participants Study terminated - closed early
The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine	1 Months Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: 9 Months

Outcome measures

Measure	Study Terminated n=5 Participants Study terminated - closed early
The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine	5 participants

Adverse Events

Revlimid + Vidaza

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Revlimid + Vidaza n=5 participants at risk Drug: Revlimid Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and \< 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21). Other Names: Lenalidomide Drug: Azacitidine Azacitidine 75 mg/m2 IV or SC D 1-5 Other Names: Vidaza
Nervous system disorders Syncope	20.0% 1/5 • Number of events 1
Musculoskeletal and connective tissue disorders Pelvic Pain	20.0% 1/5 • Number of events 1
Investigations Disease Progression	20.0% 1/5 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Mato

Hackensack University Medical Center

Phone: 551-996-2000

Email: AMato@hackensackumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place