Trial Outcomes & Findings for Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease (NCT NCT00632359)
NCT ID: NCT00632359
Last Updated: 2020-02-10
Results Overview
To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start \& end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood \&/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: \>50% increase in sum of products of =/\>2 lymph nodes on 2 consecutive examinations; One+ node must be \>2 cm or appearance of new enlarged lymph nodes; \>50% increase in liver \&/or spleen as determined by physical examination/appearance of splenomegaly not previously present; \>50% increase in circulating lymphocytes with absolute count \>10,000.
COMPLETED
PHASE2
33 participants
Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide Consolidation
2020-02-10
Participant Flow
Recruitment Period: February 28, 2008 to January 7, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Lenalidomide
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lenalidomide
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=33 Participants
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 Months, Disease status assessed at Start/End of Lenalidomide ConsolidationPopulation: Of the three participants registered, two were not evaluable for response.
To evaluate ability of lenalidomide to improve quality of remission (e.g. from partial remission (PR) to complete remission (CR)), disease status assessed at start \& end of Lenalidomide consolidation. NCI Working Group Response Criteria: Participants who began therapy in PR, improvement of status to nodular partial remission (nPR) or CR; Participants in nPR (otherwise CR, bone marrow nodules identified histologically), improvement of status to CR. Participants in CR, resolution of measurable disease in blood \&/or bone marrow per immuno flow cytometry or PCR testing. Progressive Disease (PD): One or more of following: \>50% increase in sum of products of =/\>2 lymph nodes on 2 consecutive examinations; One+ node must be \>2 cm or appearance of new enlarged lymph nodes; \>50% increase in liver \&/or spleen as determined by physical examination/appearance of splenomegaly not previously present; \>50% increase in circulating lymphocytes with absolute count \>10,000.
Outcome measures
| Measure |
Lenalidomide
n=31 Participants
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation
Response
|
10 participants
|
|
Improvement in Quality of Remission: Number of Participants With Response Versus No Response by NCI Working Group Criteria Disease Status Change at Start/End of Lenalidomide Consolidation
No Response
|
21 participants
|
PRIMARY outcome
Timeframe: 12 Months, Disease status assessed at the End of Lenalidomide ConsolidationPopulation: Of the 33 participants who were treated, two Participants were not evaluable.
Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Nodular Partial Remission (nPR) is CR with bone marrow nodules identified histologically. Progressive disease (PD), defined as ≥ 50% rise in lymphocyte count to \> 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, PR or PD.
Outcome measures
| Measure |
Lenalidomide
n=31 Participants
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria
CR, MRD Positive or Negative
|
13 participants
|
|
Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria
PR
|
8 participants
|
|
Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria
nPR
|
7 participants
|
|
Response Assessments: Disease Status at the End of Lenalidomide Consolidation Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Response Criteria
PD
|
1 participants
|
PRIMARY outcome
Timeframe: From baseline to 12 monthsPopulation: Of the 33 participants treated, two were not evaluable for outcome assessment due to early departure from study.
Time from the start of study drug therapy to the first documentation of disease progression. Progressive disease characterized by at least one of the following: \>50% increase in the sum of products of at least 2 lymph nodes on 2 consecutive examinations. At least one node larger than 2 cm. Or, appearance of new enlarged lymph nodes. \>50% increase in size of liver and/or spleen as determined by physical examination or appearance of splenomegaly which was not previously present. \>50% increase in number of circulating lymphocytes with absolute count of at least 10,000.
Outcome measures
| Measure |
Lenalidomide
n=31 Participants
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Time to Progression
|
8 Months
Interval 6.6 to 9.4
|
Adverse Events
Lenalidomide
Serious adverse events
| Measure |
Lenalidomide
n=33 participants at risk
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
24.2%
8/33 • Number of events 8 • Adverse event collection for 12 months of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Infections and infestations
Infections, Respiratory syncytial virus (RSV)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
Other adverse events
| Measure |
Lenalidomide
n=33 participants at risk
Lenalidomide 10 mg daily given for 12 months.
|
|---|---|
|
Investigations
ALKALINE PHOSPHATASE INCREASE
|
3.0%
1/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
6.1%
2/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Investigations
Alanine aminotransferase Increased (ALT, SGPT)
|
6.1%
2/33 • Number of events 7 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Investigations
Aspartate aminotransferase increased (AST, SGOT)
|
6.1%
2/33 • Number of events 5 • Adverse event collection for 12 months of treatment.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Ear and labyrinth disorders
AUDITORY/EAR (OTHER)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Blood and lymphatic system disorders
BILIRUBIN INCREASED
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Cardiac disorders
CARDIAC ISCHEMIA/INFARCTION
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
18.2%
6/33 • Number of events 6 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
24.2%
8/33 • Number of events 8 • Adverse event collection for 12 months of treatment.
|
|
Investigations
CREATININE INCREASED
|
18.2%
6/33 • Number of events 8 • Adverse event collection for 12 months of treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN (OTHER)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
DIABETES (Hyperglycemia)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Gastrointestinal disorders
DIARRHEA
|
27.3%
9/33 • Number of events 11 • Adverse event collection for 12 months of treatment.
|
|
General disorders
DISTENSION/BLOATING
|
9.1%
3/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Nervous system disorders
DIZZINESS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Endocrine disorders
ENDOCRINE (OTHER: adrenal difference)
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
General disorders
FATIGUE
|
48.5%
16/33 • Number of events 17 • Adverse event collection for 12 months of treatment.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Gastrointestinal disorders
FLATULENCE
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
General disorders
FLU-LIKE SYNDROME
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Gastrointestinal disorders
GASTRITIS
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Gastrointestinal disorders
GASTROINTESTINAL (OTHER)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Ear and labyrinth disorders
HEARING CHANGE (WITHOUT MONITORING)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Investigations
HEMOGLOBIN INCREASED
|
54.5%
18/33 • Number of events 22 • Adverse event collection for 12 months of treatment.
|
|
Renal and urinary disorders
HEMORRHAGE, Genitourinary
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY (NOSE)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Reproductive system and breast disorders
HOT FLASHES
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
12.1%
4/33 • Number of events 6 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPERTENSION
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
3.0%
1/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
6.1%
2/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Infections and infestations
INFECTION
|
12.1%
4/33 • Number of events 4 • Adverse event collection for 12 months of treatment.
|
|
Psychiatric disorders
INSOMNIA
|
9.1%
3/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
39.4%
13/33 • Number of events 16 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
MAGNESIUM, SERUM-HIGH
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY (OTHER)
|
30.3%
10/33 • Number of events 16 • Adverse event collection for 12 months of treatment.
|
|
Psychiatric disorders
MOOD ALTERATION (AGITATION)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Psychiatric disorders
MOOD ALTERATION (ANXIETY)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Psychiatric disorders
MOOD ALTERATION (DEPRESSION)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Musculoskeletal and connective tissue disorders
MOTOR SKILLS, AFFECTED
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
15.2%
5/33 • Number of events 5 • Adverse event collection for 12 months of treatment.
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
6.1%
2/33 • Number of events 2 • Adverse event collection for 12 months of treatment.
|
|
Blood and lymphatic system disorders
Neutrophils, AGC (absolute granulocyte counts) Increased
|
51.5%
17/33 • Number of events 31 • Adverse event collection for 12 months of treatment.
|
|
Renal and urinary disorders
OBSTRUCTION, GU (BLADDER)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Eye disorders
OCULAR/VISUAL (OTHER)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Infections and infestations
PHLEBITIS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Investigations
Platelet count decreased
|
36.4%
12/33 • Number of events 16 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.1%
2/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY (OTHER)
|
9.1%
3/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
24.2%
8/33 • Number of events 11 • Adverse event collection for 12 months of treatment.
|
|
Renal and urinary disorders
RENAL FAILURE
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Renal and urinary disorders
RENAL/GENITOURINARY (OTHER)
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY SYMPTOMS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
General disorders
RIGORS/CHILLS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
6.1%
2/33 • Number of events 3 • Adverse event collection for 12 months of treatment.
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Ear and labyrinth disorders
TINNITUS
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
Investigations
TUMOR FLARE REACTION
|
12.1%
4/33 • Number of events 4 • Adverse event collection for 12 months of treatment.
|
|
Nervous system disorders
VOICE CHANGES
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
|
General disorders
PAIN
|
24.2%
8/33 • Number of events 8 • Adverse event collection for 12 months of treatment.
|
|
General disorders
FEVER
|
3.0%
1/33 • Number of events 1 • Adverse event collection for 12 months of treatment.
|
Additional Information
Alessandra Ferrajoli, Professor, Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place