Trial Outcomes & Findings for Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT01002755)

Last Updated: 2019-05-07

Results Overview

A Simon's two-stage minmax design will be used. Includes complete remission (CR) and partial remission (PR). Complete Response Requires the absence of disease signs and symptoms, and normalization of Peripheral blood and bone marrow. Partial Response it at lease a 50% reduction in disease signs and symptoms and normalization of peripheral blood.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Up to 8 years

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Lenalidomide, Ofatumumab) Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Lenalidomide, Ofatumumab) n=36 Participants Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Age, Continuous	64 years n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	27 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	32 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	36 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 8 years

Population: Two participants were not evaluable for response.

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide, Ofatumumab) n=34 Participants Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Overall Response Rate	24 Participants

SECONDARY outcome

Timeframe: Up to 8 years

Incidence of grade 3 and 4 non-hematological toxicity in more than 50 percent of the participants. Will be monitored based on the Bayesian model (beta-binomial).

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide, Ofatumumab) n=36 Participants Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Number of Participants With Tolerance of the Medication Combination	0 participants

SECONDARY outcome

Timeframe: Up to 8 years

The time from the start of therapy to death, disease progression, or the initiation of the next therapy. Disease progression is the loss of response or transformation to a more aggressive histology.

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide, Ofatumumab) n=34 Participants Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Progression Free Survival	16 months Interval 2.0 to 26.0

Adverse Events

Treatment (Lenalidomide, Ofatumumab)

Serious events: 13 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Lenalidomide, Ofatumumab) n=36 participants at risk Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	2.8% 1/36 • Number of events 1 • 1 year
Surgical and medical procedures Appendectomy	2.8% 1/36 • Number of events 1 • 1 year
Cardiac disorders Atrial Fibrillation	2.8% 1/36 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	5.6% 2/36 • Number of events 4 • 1 year
General disorders Fatigue	2.8% 1/36 • Number of events 1 • 1 year
General disorders Fever	8.3% 3/36 • Number of events 4 • 1 year
Surgical and medical procedures Hernia repair	2.8% 1/36 • Number of events 1 • 1 year
Infections and infestations Infection	8.3% 3/36 • Number of events 3 • 1 year
Infections and infestations Meninogencephalitis	2.8% 1/36 • Number of events 1 • 1 year
Infections and infestations Neutropenic Fever	2.8% 1/36 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.8% 1/36 • Number of events 1 • 1 year
Blood and lymphatic system disorders Thrombosis	5.6% 2/36 • Number of events 2 • 1 year
General disorders Weakness	2.8% 1/36 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Treatment (Lenalidomide, Ofatumumab) n=36 participants at risk Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Ofatumumab: Given IV
Skin and subcutaneous tissue disorders Acne	8.3% 3/36 • Number of events 3 • 1 year
Investigations Allergic Drug Reaction	22.2% 8/36 • Number of events 11 • 1 year
Blood and lymphatic system disorders Anemia	27.8% 10/36 • Number of events 10 • 1 year
Gastrointestinal disorders Constipation	33.3% 12/36 • Number of events 12 • 1 year
General disorders Cough	22.2% 8/36 • Number of events 8 • 1 year
Skin and subcutaneous tissue disorders Dermatology/Skin	5.6% 2/36 • Number of events 2 • 1 year
Gastrointestinal disorders Diarrhea	41.7% 15/36 • Number of events 15 • 1 year
Gastrointestinal disorders Distention/Bloating	5.6% 2/36 • Number of events 2 • 1 year
Eye disorders Dry eye	5.6% 2/36 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders Dry Skin	5.6% 2/36 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	13.9% 5/36 • Number of events 5 • 1 year
Blood and lymphatic system disorders Edema Limb	5.6% 2/36 • Number of events 2 • 1 year
General disorders Fatigue	44.4% 16/36 • Number of events 16 • 1 year
General disorders Fever	38.9% 14/36 • Number of events 14 • 1 year
Metabolism and nutrition disorders Hyperglycemia	5.6% 2/36 • Number of events 2 • 1 year
Metabolism and nutrition disorders Hypomagnesemia	5.6% 2/36 • Number of events 2 • 1 year
Infections and infestations Infection	55.6% 20/36 • Number of events 20 • 1 year
Nervous system disorders Insomnia	5.6% 2/36 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Muscle Weakness	5.6% 2/36 • Number of events 2 • 1 year
Gastrointestinal disorders Nausea	25.0% 9/36 • Number of events 9 • 1 year
Nervous system disorders Neurology other	13.9% 5/36 • Number of events 5 • 1 year
Blood and lymphatic system disorders Neutropenia	63.9% 23/36 • Number of events 23 • 1 year
General disorders Pain	44.4% 16/36 • Number of events 16 • 1 year
Respiratory, thoracic and mediastinal disorders Pleural Effusion	5.6% 2/36 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders Pruritis	16.7% 6/36 • Number of events 6 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary Other	8.3% 3/36 • Number of events 3 • 1 year
Skin and subcutaneous tissue disorders Rash/desquamation	5.6% 2/36 • Number of events 2 • 1 year
General disorders Sweating	5.6% 2/36 • Number of events 2 • 1 year
Blood and lymphatic system disorders Thrombocytopenia	33.3% 12/36 • Number of events 12 • 1 year
Immune system disorders Tumor Flare	19.4% 7/36 • Number of events 7 • 1 year
Gastrointestinal disorders Vomiting	8.3% 3/36 • Number of events 3 • 1 year

Additional Information

Ferrajoli,Alessandra M.D.

The University of Texas M D Anderson Cancer Center

Phone: 713-792-2063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place