Trial · NCT00875667

A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

NCT00875667, Phase 2, Completed, Celgene; results first posted 2019-09-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL). Trials, record NCT00875667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00875667

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
NCT number: NCT00875667
Status: Completed
Phases: Phase 2
Enrollment: 254 participants, actual
Lead sponsor: Celgene
Conditions: Mantle Cell Lymphoma, Lymphoma, Mantle-Cell
Interventions: Lenalidomide, Investigators choice single agent
First posted: 2009-04-03
Last updated: 2019-09-16
Results first posted: 2019-09-16

Source ClinicalTrials.gov

Registered outcomes47

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review	From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks	PFS was defined as time of randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.
Primary	Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis	From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks	Kaplan Meier estimates of PFS were defined as the time from randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last completed assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.
Secondary	Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm	Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who discontinued before any response had been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.
Secondary	Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis	From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm	Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses.
Secondary	Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm	Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.
Secondary	Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis	From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm	Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.
Secondary	Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm	Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease.
Secondary	Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis	From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm	Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease.
Secondary	Kaplan Meier Estimate of Time to Progression According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm	Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.
Secondary	Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis	From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm	Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free.

1 to 10 of 47Source ClinicalTrials.gov

See all 47 registered outcomes

Outcomes47

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review	From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks	ITT population included all randomized participants.	weeks	MEDIAN
PRIMARY	Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis	From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks	ITT population included all randomized participants.	weeks	MEDIAN
SECONDARY	Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm	ITT population included all randomized participants.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis	From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm	ITT population included all randomized participants.	Percentage of Participants	NUMBER
SECONDARY	Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm	The analysis population included participants with an overall response.	Weeks	MEDIAN
SECONDARY	Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis	From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm	The analysis population included participants with an overall response.	Weeks	MEDIAN
SECONDARY	Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm	ITT population includes all randomized participants.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis	From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm	ITT population includes all randomized participants.	Percentage of participants	NUMBER
SECONDARY	Kaplan Meier Estimate of Time to Progression According to the IRC Central Review	From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm	ITT population includes all randomized participants.	Weeks	MEDIAN
SECONDARY	Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis	From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm	ITT population includes all randomized participants.	Weeks	MEDIAN

1 to 10 of 47Source ClinicalTrials.gov

See all 47 outcomes

Results by group278

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review	Lenalidomide	37.6	95% Confidence Interval 24.0 to 52.6	weeks
Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review	Investigators Choice	22.7	95% Confidence Interval 15.9 to 30.1	weeks
Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis	Lenalidomide	37.3	95% Confidence Interval 24.1 to 52.6	weeks
Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis	Investigators Choice	23.6	95% Confidence Interval 15.9 to 33.3	weeks
Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review	Lenalidomide	40.0	95% Confidence Interval 32.58 to 47.78	Percentage of Participants
Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review	Investigators Choice	10.7	95% Confidence Interval 5.02 to 19.37	Percentage of Participants
Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis	Lenalidomide	45.9	95% Confidence Interval 38.23 to 53.68	Percentage of Participants
Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis	Investigators Choice	22.6	95% Confidence Interval 14.20 to 33.05	Percentage of Participants
Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review	Lenalidomide	69.6	95% Confidence Interval 41.1 to 86.7	Weeks
Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review	Investigators Choice	45.1	95% Confidence Interval 36.3 to 80.9	Weeks

1 to 10 of 278Source ClinicalTrials.gov

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Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lenalidomide	170
Overall Study	STARTED	Investigators Choice	84
Overall Study	Crossover From IC to Lenalidomide	Lenalidomide	0
Overall Study	Crossover From IC to Lenalidomide	Investigators Choice	40
Overall Study	Participants Treated	Lenalidomide	167
Overall Study	Participants Treated	Investigators Choice	83
Overall Study	COMPLETED	Lenalidomide	0
Overall Study	COMPLETED	Investigators Choice	11
Overall Study	NOT COMPLETED	Lenalidomide	170
Overall Study	NOT COMPLETED	Investigators Choice	73

Source ClinicalTrials.gov

Adverse events318

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
other	ANAEMIA	Blood and lymphatic system disorders	Lenalidomide	45	167
other	ANAEMIA	Blood and lymphatic system disorders	Investigator's Choice	18	83
other	LEUKOPENIA	Blood and lymphatic system disorders	Lenalidomide	29	167
other	LEUKOPENIA	Blood and lymphatic system disorders	Investigator's Choice	18	83
other	LYMPHOPENIA	Blood and lymphatic system disorders	Lenalidomide	8	167
other	LYMPHOPENIA	Blood and lymphatic system disorders	Investigator's Choice	6	83
other	NEUTROPENIA	Blood and lymphatic system disorders	Lenalidomide	86	167
other	NEUTROPENIA	Blood and lymphatic system disorders	Investigator's Choice	29	83
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Lenalidomide	63	167
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	Investigator's Choice	33	83

1 to 10 of 318Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lenalidomide	119	167
Total, all-cause mortality	Investigator's Choice	59	83
Total, other adverse events	Lenalidomide	146	167
Total, other adverse events	Investigator's Choice	61	83
Total, serious adverse events	Lenalidomide	75	167
Total, serious adverse events	Investigator's Choice	22	83

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26899778	BACKGROUND	PubMed
28771673	DERIVED	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lenalidomide vs Investigator's Choice: deaths from any cause	Trial comparisons
Lenalidomide vs Investigator's Choice: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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