Trial Outcomes & Findings for Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients (NCT NCT00493181)

Results Overview

Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (\>/= 3 months) platelet count \>/= 60 x 10\^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (\>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)

Results posted on

2012-02-20

Participant Flow

Recruitment Period 10/15/05 to 9/17/07. All participants registered at The University of Texas M.D. Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Interleukin-11 Starting dose 10 mcg/kg subcutaneously 3 times a week
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interleukin-11 n=8 Participants Starting dose 10 mcg/kg subcutaneously 3 times a week
Age Continuous	55 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly platelet count till stabilized with on-going review while receiving treatment (study total 2 years)

Number of participants with platelet response of 'Complete Response' (CR) defined as a sustained (\>/= 3 months) platelet count \>/= 60 x 10\^9/L while continuing tyrosine kinase inhibitor (TKI) therapy or sustained (\>/= 3 months) re-escalation of TKI dose to the pre-thrombocytopenia level without recurrence of thrombocytopenia.

Outcome measures

Outcome measures
Measure	Interleukin-11 n=8 Participants Starting dose 10 mcg/kg subcutaneously 3 times a week
Number of Participants With Complete Response	3 Participants

Adverse Events

Interleukin-11

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interleukin-11 n=8 participants at risk Starting dose 10 mcg/kg subcutaneously 3 times a week
General disorders Edema	50.0% 4/8 • Number of events 4 • 2 years
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • 2 years
General disorders Fatigue	12.5% 1/8 • Number of events 1 • 2 years
Eye disorders Blurry Vision	12.5% 1/8 • Number of events 1 • 2 years

Additional Information

Jorge Cortes M.D./Professor

The University of Texas M. D. Anderson Cancer Center

Phone: 713/794-5783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place