Trial Outcomes & Findings for Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia (NCT NCT00759603)

Last Updated: 2015-08-27

Results Overview

Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly \& constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes\>1500/µL, platelets\>100,000/µL, hemoglobin\>11.0 g/dL (untransfused); lymphocyte count \<5,000/µL; Bone marrow aspirate \& biopsy normocellular for age with \<30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia \& bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, \&/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets\>100,000/µL or 50% improvement; Hemoglobin\>11.0 g/dL (untransfused) or 50% improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.

Results posted on

2015-08-27

Participant Flow

Recruitment Period: September 22, 2008 to November 02, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.

One of the 60 participants enrolled was excluded from the trial before any treatment assignment.

Participant milestones

Participant milestones
Measure	Lenalidomide + Rituximab Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m\^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Overall Study STARTED	59
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide + Rituximab n=59 Participants Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m\^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Age, Continuous	62 years n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	46 Participants n=93 Participants
Region of Enrollment United States	59 participants n=93 Participants

PRIMARY outcome

Timeframe: Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.

Outcome measures

Outcome measures
Measure	Lenalidomide + Rituximab n=59 Participants Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m\^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines	66 Percentage of Participants

Adverse Events

Lenalidomide + Rituximab

Serious events: 29 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide + Rituximab n=59 participants at risk Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m\^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Cardiac disorders Acute Myocardial Infarction	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Cardiac disorders Atrial Fibrillation	3.4% 2/59 • Number of events 3 • Adverse event collected through 12 cycles of 28-days.
Cardiac disorders Cardiac arrhythmia	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Cardiac disorders Cardiac other	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Cardiac disorders Left ventricular diastolic dysfunction	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Cardiac disorders Left ventricular systolic dysfunction	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Abdominal mass	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Constipation	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Diarrhea	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
General disorders Abdominal pain	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
General disorders Death	3.4% 2/59 • Number of events 2 • Adverse event collected through 12 cycles of 28-days.
General disorders Fever	3.4% 2/59 • Number of events 3 • Adverse event collected through 12 cycles of 28-days.
General disorders Tumor lysis syndrome	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Acute bronchitis	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Catheter related infection	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Neutropenic fever	11.9% 7/59 • Number of events 8 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Perianal infection	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Pulmonary infection RSV	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Skin infection	3.4% 2/59 • Number of events 2 • Adverse event collected through 12 cycles of 28-days.
Metabolism and nutrition disorders Hypokalemia	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary malignancy	5.1% 3/59 • Number of events 3 • Adverse event collected through 12 cycles of 28-days.
Nervous system disorders Syncope	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Renal and urinary disorders Acute renal failure	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Surgical and medical procedures Elective surgery, right knee	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Blood and lymphatic system disorders Autoimmune hemolytic anemia	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Blood and lymphatic system disorders Evan's syndrome	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Blood and lymphatic system disorders Left leg swelling	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Cardiac disorders Thrombus	1.7% 1/59 • Number of events 1 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Enteritis	3.4% 2/59 • Number of events 2 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Lung Infection	15.3% 9/59 • Number of events 17 • Adverse event collected through 12 cycles of 28-days.

Other adverse events

Other adverse events
Measure	Lenalidomide + Rituximab n=59 participants at risk Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m\^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Blood and lymphatic system disorders Neutropenia	72.9% 43/59 • Number of events 43 • Adverse event collected through 12 cycles of 28-days.
Blood and lymphatic system disorders Thrombocytopenia	33.9% 20/59 • Number of events 20 • Adverse event collected through 12 cycles of 28-days.
Blood and lymphatic system disorders Anemia	15.3% 9/59 • Number of events 9 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Penumonia/bronchitis	10.2% 6/59 • Number of events 6 • Adverse event collected through 12 cycles of 28-days.
General disorders fatigue	54.2% 32/59 • Number of events 32 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Diarrhea	35.6% 21/59 • Number of events 21 • Adverse event collected through 12 cycles of 28-days.
General disorders Tumor flare	27.1% 16/59 • Number of events 16 • Adverse event collected through 12 cycles of 28-days.
Nervous system disorders Sensory neuropathy	23.7% 14/59 • Number of events 14 • Adverse event collected through 12 cycles of 28-days.
Skin and subcutaneous tissue disorders Rash	22.0% 13/59 • Number of events 13 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Constipation	18.6% 11/59 • Number of events 11 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Nausea	16.9% 10/59 • Number of events 10 • Adverse event collected through 12 cycles of 28-days.
Nervous system disorders Neurologic other	16.9% 10/59 • Number of events 10 • Adverse event collected through 12 cycles of 28-days.
Musculoskeletal and connective tissue disorders Arthralgia	16.9% 10/59 • Number of events 10 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Anorexia	15.3% 9/59 • Number of events 9 • Adverse event collected through 12 cycles of 28-days.
Metabolism and nutrition disorders Metabolic or laboratory	15.3% 9/59 • Number of events 9 • Adverse event collected through 12 cycles of 28-days.
Metabolism and nutrition disorders Hyperglycemia	13.6% 8/59 • Number of events 8 • Adverse event collected through 12 cycles of 28-days.
Skin and subcutaneous tissue disorders Pruritus	13.6% 8/59 • Number of events 8 • Adverse event collected through 12 cycles of 28-days.
Renal and urinary disorders Elevated serum creatinine	11.9% 7/59 • Number of events 7 • Adverse event collected through 12 cycles of 28-days.
General disorders Gastrointestinal pain	11.9% 7/59 • Number of events 7 • Adverse event collected through 12 cycles of 28-days.
Metabolism and nutrition disorders Hypomagnesemia	11.9% 7/59 • Number of events 7 • Adverse event collected through 12 cycles of 28-days.
Metabolism and nutrition disorders Hyperbilirubinemia	11.9% 7/59 • Number of events 7 • Adverse event collected through 12 cycles of 28-days.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.2% 6/59 • Number of events 6 • Adverse event collected through 12 cycles of 28-days.
Blood and lymphatic system disorders Peripheral edema	10.2% 6/59 • Number of events 6 • Adverse event collected through 12 cycles of 28-days.
Gastrointestinal disorders Heartburn	10.2% 6/59 • Number of events 6 • Adverse event collected through 12 cycles of 28-days.
General disorders Headache	10.2% 6/59 • Number of events 6 • Adverse event collected through 12 cycles of 28-days.
Infections and infestations Neutropenic fever	10.2% 6/59 • Number of events 6 • Adverse event collected through 12 cycles of 28-days.

Additional Information

Alessandra Ferrajoli, MD/Professor, Leukemia

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place