Trial Outcomes & Findings for Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT02225275)

Last Updated: 2022-09-28

Results Overview

Response is Complete Response or Partial Response. CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes \< 4000/ul, normocellular, \<30% lymphocytes, no B-lymphoid nodules, Platelets \> 100,000/ul, hemoglobin \>11.0 g/dl and Neutrophils \>1500/ul. PR is \>/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count \> 100,000/ul, Hemoglobin \> 11 g/dl and Neutrophils \>1500/ul or increase \>/= 50% of all over base.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2022-09-28

Participant Flow

Recruitment Period: March 2016 to May 2021

Participant milestones

Participant milestones
Measure	Treatment (Lenalidomide, Obinutuzumab) Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Lenalidomide, Obinutuzumab) n=9 Participants Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide, Obinutuzumab) n=9 Participants Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Number of Participants With a Response	5 Participants

SECONDARY outcome

Timeframe: Up to 5 years, 2 months

The time-to-event outcomes (such as time to next treatment or overall survival). Time to Next Treatment is from start of study medication to the start of the next treatment, or last follow up if no next therapy.

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide, Obinutuzumab) n=9 Participants Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Time to Next Treatment	26.9 Months Interval 2.7 to 62.0

SECONDARY outcome

Timeframe: Up to 5 years, 2 months

Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.

Outcome measures

Outcome measures
Measure	Treatment (Lenalidomide, Obinutuzumab) n=9 Participants Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Overall Survival	NA Months Interval 2.7 to 62.0 Median not reached due to insufficient number of participants with events.

Adverse Events

Treatment (Lenalidomide, Obinutuzumab)

Serious events: 4 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Lenalidomide, Obinutuzumab) n=9 participants at risk Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Cardiac disorders Chest Pain	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Number of events 2 • Up to 5 years, 2 months
Injury, poisoning and procedural complications fall	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Blood and lymphatic system disorders Febrile Neutropenia	22.2% 2/9 • Number of events 2 • Up to 5 years, 2 months
General disorders Fever	22.2% 2/9 • Number of events 3 • Up to 5 years, 2 months
Respiratory, thoracic and mediastinal disorders Respiratory Failure	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months

Other adverse events

Other adverse events
Measure	Treatment (Lenalidomide, Obinutuzumab) n=9 participants at risk Patients receive obinutuzumab IV over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide PO QD on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment with obinutuzumab repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Obinutuzumab: Given IV
Investigations Alanine aminiotransferase increased	22.2% 2/9 • Number of events 2 • Up to 5 years, 2 months
Investigations Alkaline Phosphatase Increased	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Number of events 4 • Up to 5 years, 2 months
Investigations Aspartate Aminotransferase	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
General disorders Back Pain	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
General disorders Bruising	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Infections and infestations Conjunctivitis	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Ear and labyrinth disorders Ear Inflammation	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
General disorders Fatigue	44.4% 4/9 • Number of events 4 • Up to 5 years, 2 months
Blood and lymphatic system disorders Febrile Neutropenia	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
General disorders Fever	33.3% 3/9 • Number of events 4 • Up to 5 years, 2 months
Gastrointestinal disorders Gastroesophageal Reflux Disease	22.2% 2/9 • Number of events 2 • Up to 5 years, 2 months
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Injury, poisoning and procedural complications Infusion Related Reaction	22.2% 2/9 • Number of events 2 • Up to 5 years, 2 months
Psychiatric disorders Insomina	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Infections and infestations Lung Infection	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Blood and lymphatic system disorders Lymph Node Pain	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Gastrointestinal disorders Nausea	44.4% 4/9 • Number of events 4 • Up to 5 years, 2 months
Investigations Neutropenia	77.8% 7/9 • Number of events 19 • Up to 5 years, 2 months
Nervous system disorders Peripheral Sensory Neuropathy	22.2% 2/9 • Number of events 2 • Up to 5 years, 2 months
Investigations Thrombocytopenia	33.3% 3/9 • Number of events 7 • Up to 5 years, 2 months
Respiratory, thoracic and mediastinal disorders Pleural Effusion	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Skin and subcutaneous tissue disorders Rash Maculo-papular	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Eye disorders Sclera Disorder	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Skin and subcutaneous tissue disorders Dermatitis	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Infections and infestations Skin Infection	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Vascular disorders Thromboembolic Event	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months
Eye disorders Uveitis	11.1% 1/9 • Number of events 1 • Up to 5 years, 2 months

Additional Information

Dr. Alessandra Ferrajoli MD/ Professor

The University of Texas MD Anderson Cancer Center

Phone: 173-792-2063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place