Trial Outcomes & Findings for Sorafenib for the Treatment of Chronic Lymphocytic Leukemia (CLL) (NCT NCT01510756)

Last Updated: 2016-01-21

Results Overview

Determination of absolute lymphocyte count (ALC), lymphadenopathy, splenomegaly, and/or marrow leukemia as measured by 4-color flow minimal residual disease (MRD) panel after 3 cycles of study treatment. (Decrease in absolute lymphocyte count by 50%, decrease in lymphadenopathy (sum of lymph node product) by 50%, decrease in splenomegaly by 50%, or decrease in leukemia infiltration of the bone marrow by 50%.)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

3 months

Results posted on

2016-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.
Overall Study Death	1
Overall Study Lack of Efficacy	2
Overall Study Physician Decision	1

Baseline Characteristics

Sorafenib for the Treatment of Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib n=4 Participants Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Zero participants analyzed due to termination of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two months following completion of treatment with sorafenib according to iwCLL guidelines.

Population: zero participants analyzed due to termination of study

A response assessment must be performed 2 months following completion of therapy to document responses, including a bone marrow if in clinical response (CR) and a computed tomography (or magnetic resonance imaging scan \[MRI\]) if initial imaging was abnormal or physical examination inconclusive.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: zero participants analyzed due to termination of study

Frequency, severity and relatedness of adverse events

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib n=4 participants at risk Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.
Infections and infestations Brain abscess (aspergillus)	25.0% 1/4

Other adverse events

Other adverse events
Measure	Sorafenib n=4 participants at risk Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.
Gastrointestinal disorders Abdominal pain	25.0% 1/4
Skin and subcutaneous tissue disorders alopecia	25.0% 1/4
Metabolism and nutrition disorders Amylase elevation	25.0% 1/4
Metabolism and nutrition disorders anorexia	50.0% 2/4
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4
Gastrointestinal disorders Constipation	25.0% 1/4
Gastrointestinal disorders Diarrhea	75.0% 3/4
General disorders Fatigue	50.0% 2/4
Skin and subcutaneous tissue disorders Hand foot syndrome	75.0% 3/4
Gastrointestinal disorders Hemorrhoids	25.0% 1/4
Respiratory, thoracic and mediastinal disorders Hoarseness	25.0% 1/4
Hepatobiliary disorders hyperbillirubinema	25.0% 1/4
Metabolism and nutrition disorders Lipase elevation	25.0% 1/4
Gastrointestinal disorders Nausea	25.0% 1/4
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4
Renal and urinary disorders Polyuria	50.0% 2/4
Skin and subcutaneous tissue disorders Rash	25.0% 1/4
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	25.0% 1/4
Blood and lymphatic system disorders neutropenia	25.0% 1/4
Blood and lymphatic system disorders thrombocytopenia	50.0% 2/4

Additional Information

Thomas Kipps, MD

University of California, San Diego

Phone: (858) 534-5400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place