Trial · NCT00910910
Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
NCT00910910, Phase 3, Completed, Celgene; results first posted 2016-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial). Trials, record NCT00910910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00910910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
- NCT number
- NCT00910910
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 450 participants, actual
- Lead sponsor
- Celgene
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Interventions
- Lenalidomide, Chlorambucil
- First posted
- 2009-06-01
- Last updated
- 2019-07-09
- Other registries' IDs
- eudract:2008-003079-32
- Results first posted
- 2016-12-21
- Limitations and caveats
After notification by the US Food and Drug Administration on 12Jul2013, Celgene agreed to stop lenalidomide due to an imbalance in the number of deaths on the lenalidomide arm versus the chlorambucil arm; no causality for the imbalance was identified
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimate of Progression Free Survival (PFS) | From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months | Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost 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 |
| Primary | Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014 | From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months | Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator's assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (\> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil | AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death |
| Secondary | Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014 | From randomization to the data cut-off date of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil | AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death |
| Secondary | Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines | Up to data cut-off date of 18 Feb 2013; approximately 39 months | A best overall response rate is a CR, CRi, nPR or PR and is defined as: Complete Remission (CR): * No lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Polymorphonuclear leukocytes ≥ 1500/ul * No circulating clonal B-lymphocytes * Platelets \> 100,000/ul * Hemoglobin \> 11.0 g/dl * Normocellular \<30% lymphocytes, no B-lymphoid nodules; Incomplete Clinical Response (CRi): • CR without bone marrow biopsy confirmation. Nodular Partial Response (nPR): • CR with the presence of residual clonal nodules. Partial Response (PR) requires: * ≥ 50% decrease in peripheral blood lymphocyte count * ≥ 50% reduction in lymphadenopathy * ≥ 50% reduction in size of liver and/or spleen * 1 or more of the following: * Polymorphonuclear leukocytes ≥ 1500/ul * Platelets \>100,000/ul |
| Secondary | Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014 | Up to data cut-off of 31 March 2014; approximately 53 months | A best overall response rate is a CR, CRi, nPR or PR and is defined as: Complete Remission (CR): * No lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Polymorphonuclear leukocytes ≥ 1500/ul * No circulating clonal B-lymphocytes * Platelets \> 100,000/ul * Hemoglobin \> 11.0 g/dl * Normocellular \<30% lymphocytes, no B-lymphoid nodules; Incomplete Clinical Response (CRi): • CR without bone marrow biopsy confirmation. Nodular Partial Response: • CR with the presence of residual clonal nodules. Partial Response requires: * ≥ 50% decrease in peripheral blood lymphocyte count * ≥ 50% reduction in lymphadenopathy * ≥ 50% reduction in size of liver and/or spleen * 1 or more of the following: * Polymorphonuclear leukocytes ≥ 1500/ul * Platelets \>100,000/ul |
| Secondary | Kaplan-Meier Estimate for Duration of Response | Up to data cut-off of 18 Feb 2013; up to approximately 39 months | Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had withdrawn consent or were lost to follow-up prior to documentation of progression |
| Secondary | Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014 | Up to data cut-off of 31 March 2014; up to approximately 53 months | Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression |
| Secondary | Time to Response | Up to data cut-off of 18 Feb 2013; up to approximately 39 months | Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines |
| Secondary | Time to Response for a Later Cut-off Date of 31 March 2014 | Up to data cut-off of 31 March 2014; up to approximately 53 months | Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimate of Progression Free Survival (PFS) | From first dose of study drug to date of data cut-off of 18 Feb 2013; up to approximately 39 months | This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The ITT population was defined as all participants who were randomized, independent of whether they received study treatment or not. | months | MEDIAN |
| PRIMARY | Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014 | From randomization to data cut off date of 31 March 2014; median follow up time for all participants was 12.6 months | The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil | This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil) as of the data cut off date of 18 Feb 2013 | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events With a Later Cut-off Date of 31 March 2014 | From randomization to the data cut-off date of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil | The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil). | participants | NUMBER |
| SECONDARY | Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines | Up to data cut-off date of 18 Feb 2013; approximately 39 months | This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Best Overall Response Based on IWCLL Guidelines With a Later Cut-off Date of 31 March 2014 | Up to data cut-off of 31 March 2014; approximately 53 months | The Intent-to-Treat population was defined as all participants who were randomized, independent of whether they received study treatment or not | percentage of participants with response | NUMBER |
| SECONDARY | Kaplan-Meier Estimate for Duration of Response | Up to data cut-off of 18 Feb 2013; up to approximately 39 months | Intent to Treat population with an objective response as of 18 Feb 2013; includes responders | weeks | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate for Duration of Response With a Later Cut-off Date of 31 March 2014 | Up to data cut-off of 31 March 2014; up to approximately 53 months | Intent to Treat population with an objective response as of 31 March 2014; includes responders. | weeks | MEDIAN |
| SECONDARY | Time to Response | Up to data cut-off of 18 Feb 2013; up to approximately 39 months | ITT participants with an objective response as of 18 February 2013 | weeks | MEDIAN |
| SECONDARY | Time to Response for a Later Cut-off Date of 31 March 2014 | Up to data cut-off of 31 March 2014; up to approximately 53 months | ITT participants who had not progressed at the time of analysis; or those who had withdrawn consent or were lost to follow-up prior to documentation of progression. | weeks | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | Lenalidomide | 30.8 | 95% Confidence Interval 18.7 to NA | months | |
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | Chlorambucil | 23.0 | 95% Confidence Interval 19.3 to 29.2 | months | |
| Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014 | Lenalidomide | 30.8 | 95% Confidence Interval 18.7 to NA | months | |
| Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off Date of 14 March 2014 | Chlorambucil | 21.4 | 95% Confidence Interval 19.3 to 25.1 | months | |
| Number of Participants With Adverse Events (AEs) | Lenalidomide | ≥ 1 TEAE | 202 | participants | |
| Number of Participants With Adverse Events (AEs) | Chlorambucil | ≥ 1 TEAE | 186 | participants | |
| Number of Participants With Adverse Events (AEs) | Lenalidomide | ≥ 1 TEAE related to study drug | 183 | participants | |
| Number of Participants With Adverse Events (AEs) | Chlorambucil | ≥ 1 TEAE related to study drug | 139 | participants | |
| Number of Participants With Adverse Events (AEs) | Lenalidomide | ≥ 1 NCI CTC Grade 3-4 TEAE | 173 | participants | |
| Number of Participants With Adverse Events (AEs) | Chlorambucil | ≥ 1 NCI CTC Grade 3-4 TEAE | 117 | participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lenalidomide | 225 | |
| Overall Study | STARTED | Chlorambucil | 225 | |
| Overall Study | Safety Population | Lenalidomide | 224 | |
| Overall Study | Safety Population | Chlorambucil | 223 | |
| Overall Study | COMPLETED | Lenalidomide | 0 | |
| Overall Study | COMPLETED | Chlorambucil | 1 | |
| Overall Study | NOT COMPLETED | Lenalidomide | 225 | |
| Overall Study | NOT COMPLETED | Chlorambucil | 224 |
Source ClinicalTrials.gov
Adverse events434
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NEUTROPENIA | Blood and lymphatic system disorders | Lenalidomide | 126 | 224 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Chlorambucil | 74 | 223 | |
| other | VOMITING | Gastrointestinal disorders | Lenalidomide | 11 | 224 | |
| other | VOMITING | Gastrointestinal disorders | Chlorambucil | 28 | 223 | |
| other | ASTHENIA | General disorders | Lenalidomide | 19 | 224 | |
| other | ASTHENIA | General disorders | Chlorambucil | 10 | 223 | |
| other | PYREXIA | General disorders | Lenalidomide | 37 | 224 | |
| other | PYREXIA | General disorders | Chlorambucil | 18 | 223 | |
| other | NASOPHARYNGITIS | Infections and infestations | Lenalidomide | 12 | 224 | |
| other | NASOPHARYNGITIS | Infections and infestations | Chlorambucil | 3 | 223 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide | 100 | 224 |
| Total, all-cause mortality | Chlorambucil | 93 | 223 |
| Total, other adverse events | Lenalidomide | 204 | 224 |
| Total, other adverse events | Chlorambucil | 184 | 223 |
| Total, serious adverse events | Lenalidomide | 148 | 224 |
| Total, serious adverse events | Chlorambucil | 90 | 223 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28140392 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenalidomide vs Chlorambucil: Number of Participants Deaths During the Treatment and Survival Follow-Up Phase | Trial comparisons |
| Lenalidomide vs Chlorambucil: deaths from any cause | Trial comparisons |
| Lenalidomide vs Chlorambucil: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00910910
GET https://conductscience.org/api/trials/v1/NCT00910910/results?page=2