Who is sponsoring NCT00963105?

NCT00963105 is sponsored by Celgene.

What drugs are being tested in NCT00963105?

Interventions in NCT00963105: lenalidomide.

What condition does NCT00963105 study?

NCT00963105 studies Relapsed or Refractory Chronic Lymphocytic Leukemia.

Is NCT00963105 still recruiting?

NCT00963105 is currently completed. Last updated 31 October 2018.

Are results published for NCT00963105?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-10-31 · How we verify

NCT00963105

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed Phase 2 Results posted Last updated 31 October 2018

What this trial tests

Phase 2 trial testing lenalidomide in Relapsed or Refractory Chronic Lymphocytic Leukemia in 104 participants. Completed in 5 September 2017.

Timeline

19 October 2009

Primary endpoint
5 September 2017

5 September 2017

Quick facts

Lead sponsor	Celgene
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	104
Start date	19 October 2009
Primary completion	5 September 2017
Estimated completion	5 September 2017
Sites	52 locations across France, Italy, Sweden, United Kingdom, Germany, Canada, United States, Spain

Drugs / interventions tested

lenalidomide — full drug profile →

Conditions studied

Relapsed or Refractory Chronic Lymphocytic Leukemia — all drugs for Relapsed or Refractory Chronic Lymphocytic Leukemia →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Relapsed or Refractory Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events Primary · From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.

Adverse events (AEs) were graded for severity by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 with the exceptions of hematologic toxicities and tumor lysis syndrome, according to the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening or disabling AE Grade 5 = Death The investigator determined the relationship of each AE to study drug based on the timing of the AE and whether other medications, therapeutic interventions, or underlying conditions could provide a suffi

Any adverse events

Group	Value	95% CI
Lenalidomide 5 mg	34
Lenalidomide 10 mg	34
Lenalidomide 15 mg	35

Treatment-related adverse events (TRAE)

Group	Value	95% CI
Lenalidomide 5 mg	33
Lenalidomide 10 mg	34
Lenalidomide 15 mg	32

Grade 3/4 adverse events

Group	Value	95% CI
Lenalidomide 5 mg	33
Lenalidomide 10 mg	32
Lenalidomide 15 mg	34

Treatment-related Grade 3/4 adverse events

Group	Value	95% CI
Lenalidomide 5 mg	31
Lenalidomide 10 mg	32
Lenalidomide 15 mg	30

Grade 5 adverse events

Group	Value	95% CI
Lenalidomide 5 mg	4
Lenalidomide 10 mg	4
Lenalidomide 15 mg	3

Treatment-related Grade 5 adverse events

Group	Value	95% CI
Lenalidomide 5 mg	2
Lenalidomide 10 mg	2
Lenalidomide 15 mg	0

Serious adverse events

Group	Value	95% CI
Lenalidomide 5 mg	24
Lenalidomide 10 mg	24
Lenalidomide 15 mg	27

Treatment-related serious adverse events

Group	Value	95% CI
Lenalidomide 5 mg	15
Lenalidomide 10 mg	13
Lenalidomide 15 mg	20

Overall Response Rate (ORR) Secondary · Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

ORR was defined as the percentage of patients with a complete response (CR), CR with incomplete bone marrow (BM) recovery (CRi) or partial response (PR) during treatment. Response was assessed according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines. Per the guidelines, a CR required peripheral blood lymphocytes below 4 x 10\^9/L, absence of lymphadenopathy, no hepatomegaly or splenomegaly, absence of disease and blood counts neutrophils \>1.5 x 10\^9/L, platelets \>100 x 10\^9/L, hemoglobin (hgb) \>11g/dL) and BM at least normocellular for age. CRi = CR

Group	Value	95% CI
Lenalidomide 5 mg	47.1
Lenalidomide 10 mg	37.1
Lenalidomide 15 mg	40.0

Kaplan-Meier Estimate of Duration of Response Secondary · Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

Duration of response (DOR) was defined as the time from the first visit where PR, CRi, or CR was documented to progressive disease (PD). Duration of response was censored at the last date that the participant was known to be progression-free for participants who had not progressed at the time of analysis or who withdrew consent or were lost to follow-up prior to documentation of progression.

Group	Value	95% CI
Lenalidomide 5 mg	101.1	60.6 – 239.3
Lenalidomide 10 mg	35.1	22.0 – NA
Lenalidomide 15 mg	88.8	72.1 – 127.3

Time to Response Secondary · Response was assessed after 3 cycles of therapy (Week 12) and every 4 weeks thereafter until disease progression. Maximum time on study was 91 months.

Time to response (TTR) was calculated as the time from randomization to the first documented date of response (PR, CRi or CR) based on iwCLL guidelines for participants with an objective response during the treatment period.

Group	Value	95% CI
Lenalidomide 5 mg	16.9	12.1 – 74.1
Lenalidomide 10 mg	12.6	8.4 – 52.1
Lenalidomide 15 mg	12.7	12.0 – 147.3

Kaplan-Meier Estimate of Time to Progression Secondary · From randomization until the end of the study; maximum time on study was 91 months.

Time to progression (TTP) was defined as the time from randomization to the first documented progression. For participants who did not progress during the study, TTP was censored at the last adequate response assessment showing evidence of no disease progression.

Group	Value	95% CI
Lenalidomide 5 mg	96.3	20.6 – 251.3
Lenalidomide 10 mg	47.6	31.9 – 261.1
Lenalidomide 15 mg	66.3	20.1 – 89.3

Kaplan-Meier Estimate of Event-Free Survival Secondary · From randomization until the end of the study; maximum time on study was 91 months.

Event-free survival (EFS) is the interval between the start of treatment to the first sign of disease progression, or treatment for relapse or death (whichever occurred first). If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.

Group	Value	95% CI
Lenalidomide 5 mg	25.6	16.1 – 77.6
Lenalidomide 10 mg	31.9	21.1 – 47.6
Lenalidomide 15 mg	24.1	13.4 – 66.3

Kaplan-Meier Estimate of Progression Free Survival Secondary · From randomization until the end of the study; maximum time on study was 91 months.

Progression-free survival (PFS) was calculated as the time from randomization to the first documented progression or death due to any cause during or after the treatment period, whichever occurred first. The progression date was assigned to the earliest time when any progression is observed without prior missing assessments. If withdrawal of consent or loss to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.

Group	Value	95% CI
Lenalidomide 5 mg	31.4	16.1 – 96.3
Lenalidomide 10 mg	45.1	22.4 – 120.1
Lenalidomide 15 mg	66.3	16.1 – 89.3

Kaplan-Meier Estimate of Overall Survival Secondary · From randomization until the end of the study; maximum time on study was 91 months.

Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who had withdrawn consent or were lost to follow-up before death was documented.

Group	Value	95% CI
Lenalidomide 5 mg	161.0	64.9 – 209.0
Lenalidomide 10 mg	106.7	83.4 – 235.7
Lenalidomide 15 mg	154.6	80.9 – 214.7

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug to 30 days after the last dose; the maximum duration of treatment was 251, 265, and 267 weeks in the 5 mg, 10 mg, and 15 mg treatment groups respectively.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lenalidomide 5 mg

Serious: 24/34 (71%)

Deaths: 24/34

Lenalidomide 10 mg

Serious: 24/34 (71%)

Deaths: 23/34

Lenalidomide 15 mg

Serious: 27/35 (77%)

Deaths: 26/35

Serious adverse events (115 terms)

Reaction	System	Lenalidomide 5 mg	Lenalidomide 10 mg	Lenalidomide 15 mg
PNEUMONIA	Infections and infestations	—	—	—
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	—	—	—
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—
HYPERCALCAEMIA	Metabolism and nutrition disorders	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—
PYREXIA	General disorders	—	—	—
BACTERAEMIA	Infections and infestations	—	—	—
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	—	—	—
RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	—	—	—
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—	—
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	—	—	—
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	—	—	—
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	—	—	—
DEEP VEIN THROMBOSIS	Vascular disorders	—	—	—
HYPOTENSION	Vascular disorders	—	—	—
AGRANULOCYTOSIS	Blood and lymphatic system disorders	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	—	—	—
IMMUNE THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	—	—	—

Other adverse events (139 terms — click to expand)

Reaction	System	Lenalidomide 5 mg	Lenalidomide 10 mg	Lenalidomide 15 mg
NEUTROPENIA	Blood and lymphatic system disorders	—	—	—
THROMBOCYTOPENIA	Blood and lymphatic system disorders	—	—	—
FATIGUE	General disorders	—	—	—
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
ANAEMIA	Blood and lymphatic system disorders	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—
PYREXIA	General disorders	—	—	—
RASH	Skin and subcutaneous tissue disorders	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—
COUGH	Respiratory, thoracic and mediastinal disorders	—	—	—
CONSTIPATION	Gastrointestinal disorders	—	—	—
WEIGHT DECREASED	Investigations	—	—	—
DECREASED APPETITE	Metabolism and nutrition disorders	—	—	—
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	—	—	—
NIGHT SWEATS	Skin and subcutaneous tissue disorders	—	—	—
ABDOMINAL PAIN	Gastrointestinal disorders	—	—	—
BACK PAIN	Musculoskeletal and connective tissue disorders	—	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—	—
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—
OEDEMA PERIPHERAL	General disorders	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—	—	—
INSOMNIA	Psychiatric disorders	—	—	—
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—
ALANINE AMINOTRANSFERASE INCREASED	Investigations	—	—	—
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	—	—	—
DRY MOUTH	Gastrointestinal disorders	—	—	—
CHILLS	General disorders	—	—	—
ARTHRALGIA	Musculoskeletal and connective tissue disorders	—	—	—
DIZZINESS	Nervous system disorders	—	—	—
HYPOGAMMAGLOBULINAEMIA	Immune system disorders	—	—	—
BRONCHITIS	Infections and infestations	—	—	—
PNEUMONIA	Infections and infestations	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	—	—	—
HYPOKALAEMIA	Metabolism and nutrition disorders	—	—	—
HEADACHE	Nervous system disorders	—	—	—
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	—	—	—
ERYTHEMA	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: PNEUMONIA, TUMOUR FLARE, FEBRILE NEUTROPENIA, NEUTROPENIA, ABDOMINAL PAIN, HYPERCALCAEMIA, THROMBOCYTOPENIA, PYREXIA.

Data from ClinicalTrials.gov NCT00963105 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety and effectiveness of different dose regimens of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial.
Bühler A, Wendtner CM, Kipps TJ, Rassenti L, et al · · 2016 · cited 11× · PMID 26967821 · DOI 10.1038/bcj.2016.9
Approaches to Managing Safety With Lenalidomide in Hematologic Malignancies.
Blumel S, Broadway-Duren J. · · 2014 · cited 5× · PMID 26110071 · DOI 10.6004/jadpro.2014.5.4.4

Verify or expand the search:

Other trials of lenalidomide

Trials testing the same drug.

NCT05776979 — Post-Transplant Maintenance Therapy With Isatuximab Plus Lenalidomide for High-Risk Multiple Myeloma Patients · Phase 2 · recruiting
NCT05867030 — Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma · Phase 1 · withdrawn
NCT07184424 — Real-world Study of Lenalidomide After First-line Treatment Lenvatinib With PD-1 in Advanced HCC · NA · completed
NCT05846750 — Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma · Phase 2 · recruiting
NCT05260619 — Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma · Phase 2 · recruiting

Other recruiting trials for Relapsed or Refractory Chronic Lymphocytic Leukemia

Currently open trials in the same condition.

NCT05963217 — Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed o · Phase 1 · recruiting
NCT03734198 — Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lym · Phase 2 · active not recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00963105 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 31 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00963105.

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