Trial Outcomes & Findings for Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia (NCT NCT00303966)

Results Overview

Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with \>50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to week 25

Results posted on

2014-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Sorafenib Tosylate) Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sorafenib Tosylate) n=5 Participants Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	61.3 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to week 25

Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with \>50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=5 Participants Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Objective Response Rate	0 percentage of participants Interval 0.0 to 52.0

PRIMARY outcome

Timeframe: Up to 5.5 years

Population: Study terminated early and only 5 patients were enrolled.

Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=5 Participants Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression	4.6 months Standard Error 1.2

PRIMARY outcome

Timeframe: Up to 5.5 years

Population: Study terminated early and only 5 patients were enrolled.

Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Treatment (Sorafenib Tosylate) n=5 Participants Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	32.8 months Standard Error 10.5

SECONDARY outcome

Timeframe: Baseline and week 25

Population: Study terminated early with only 5 patients. Data wasn't collected for this outcome.

Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and week 25

Population: Study terminated early after enrolling only 5 patients. Data wasn't collected for this outcome.

Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and week 25

Population: Study terminated early and enrolled only 5 patients. Data wasn't collected for this outcome.

The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Sorafenib Tosylate)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sorafenib Tosylate) n=5 participants at risk Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Hepatobiliary disorders Cholecystitis	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
Infections and infestations Lung infection	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
Investigations Platelet count decreased	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.

Other adverse events

Other adverse events
Measure	Treatment (Sorafenib Tosylate) n=5 participants at risk Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
Musculoskeletal and connective tissue disorders Arthritis	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
General disorders Fatigue	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
Metabolism and nutrition disorders Hyperkalemia	40.0% 2/5 • up to 6 months Grade 3 or higher adverse events are reported.
Metabolism and nutrition disorders Hypocalcemia	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5 • up to 6 months Grade 3 or higher adverse events are reported.

Additional Information

Dr. Wendy Stock

University of Chicago

Phone: 773-834-8982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60