Trial Outcomes & Findings for Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older (NCT NCT00535873)
NCT ID: NCT00535873
Last Updated: 2018-08-21
Results Overview
ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes \>1500/µL, platelets \>100,000/µL, hemoglobin \>11.0 g/dL (untransfused); lymphocyte count \<5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \<30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets \>100,000/µL or 50% improvement ; Hemoglobin \>11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.
COMPLETED
PHASE2
61 participants
From 3 cycles (90 days) up to 6 cycles (approximately 180 days)
2018-08-21
Participant Flow
Recruitment Period: 10/3/2007 through 7/10/2009. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
Sixty-one participants were registered and signed consent for this study. One participant signed consent but never received study medication.
Participant milestones
| Measure |
Lenalidomide
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=60 Participants
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
|
|---|---|
|
Age, Continuous
|
71 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From 3 cycles (90 days) up to 6 cycles (approximately 180 days)ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes \>1500/µL, platelets \>100,000/µL, hemoglobin \>11.0 g/dL (untransfused); lymphocyte count \<5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \<30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets \>100,000/µL or 50% improvement ; Hemoglobin \>11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.
Outcome measures
| Measure |
Lenalidomide
n=60 Participants
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
|
|---|---|
|
Overall Response Rate (ORR)
|
39 participants
|
Adverse Events
Lenalidomide
Serious adverse events
| Measure |
Lenalidomide
n=60 participants at risk
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Nervous system disorders
Cerebrovascular Ischemia
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Nervous system disorders
Confusion
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Gastrointestinal disorders
Dehydration
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
2/60 • Number of events 2 • 5 years 4 months
|
|
Blood and lymphatic system disorders
Abnormal Coagulation tests
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Vascular disorders
Embolism
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
General disorders
Fatigue
|
5.0%
3/60 • Number of events 3 • 5 years 4 months
|
|
Infections and infestations
Febrile Neutropenia
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
General disorders
Fever
|
6.7%
4/60 • Number of events 4 • 5 years 4 months
|
|
Surgical and medical procedures
Hernia Repair
|
3.3%
2/60 • Number of events 2 • 5 years 4 months
|
|
Surgical and medical procedures
Hip Replacement Surgery
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Gastrointestinal disorders
Necrosis
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
2/60 • Number of events 2 • 5 years 4 months
|
|
General disorders
Pain
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Infections and infestations
Pneumonia
|
11.7%
7/60 • Number of events 7 • 5 years 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenocarcinoma
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
|
Vascular disorders
Vessel injury lower extremity
|
1.7%
1/60 • Number of events 1 • 5 years 4 months
|
Other adverse events
| Measure |
Lenalidomide
n=60 participants at risk
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
|
|---|---|
|
General disorders
Fatigue
|
53.3%
32/60 • Number of events 32 • 5 years 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
36.7%
22/60 • Number of events 22 • 5 years 4 months
|
|
General disorders
Tumor Flare
|
26.7%
16/60 • Number of events 16 • 5 years 4 months
|
|
Nervous system disorders
Sencory Neuropathy
|
23.3%
14/60 • Number of events 14 • 5 years 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.7%
13/60 • Number of events 13 • 5 years 4 months
|
|
Gastrointestinal disorders
Constipation
|
18.3%
11/60 • Number of events 11 • 5 years 4 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
10/60 • Number of events 10 • 5 years 4 months
|
|
Nervous system disorders
Neurologic - Other
|
16.7%
10/60 • Number of events 10 • 5 years 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
10/60 • Number of events 10 • 5 years 4 months
|
|
Gastrointestinal disorders
Anorexia
|
15.0%
9/60 • Number of events 9 • 5 years 4 months
|
|
Metabolism and nutrition disorders
Metabolic Laboratory abnormality
|
15.0%
9/60 • Number of events 9 • 5 years 4 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
8/60 • Number of events 8 • 5 years 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
8/60 • Number of events 8 • 5 years 4 months
|
|
Metabolism and nutrition disorders
Elevated Serum Creatinine
|
11.7%
7/60 • Number of events 7 • 5 years 4 months
|
|
General disorders
GI Pain
|
11.7%
7/60 • Number of events 7 • 5 years 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.7%
7/60 • Number of events 7 • 5 years 4 months
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
10.0%
6/60 • Number of events 6 • 5 years 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
6/60 • Number of events 6 • 5 years 4 months
|
|
Blood and lymphatic system disorders
Peripheral Edema
|
10.0%
6/60 • Number of events 6 • 5 years 4 months
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
6/60 • Number of events 6 • 5 years 4 months
|
|
General disorders
Headache
|
10.0%
6/60 • Number of events 6 • 5 years 4 months
|
Additional Information
Alessandra Ferrajoli, MD/Associate Professor
The University of Texas M D Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place