Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT)

• ClinicalTrials.gov Identifier: NCT01938001
• Recruitment Status: Active, not recruiting
• First Posted: September 10, 2013
• Results First Posted: August 13, 2019
• Last Update Posted: August 13, 2019
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Lymphoma, Non-Hodgkin
• Interventions: Drug: Rituximab; Drug: Lenalidomide; Drug: Placebo
• Enrollment: 358

Participant Flow

Recruitment Details	358 participants were randomized into the study from sites located in Belgium, Brazil, China, Czech Republic, France, Germany, Israel, Italy, Japan, Poland, Portugal, Russia, Spain, Turkey and the United States.
Pre-assignment Details	Participants were stratified by the following: previous rituximab treatment (yes, no); time since last anti-lymphoma therapy (≤ 2, > 2 years); disease histology (follicular or marginal zone lymphoma)

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Period Title: Overall Study
Started	178	180
Participants Received Treatment	176	180
Completed Treatment [1]	124	110
Completed [2]	135	133
Not Completed	43	47
Reason Not Completed
Withdrawal by Subject	25	17
Non-compliant	1	0
Participant Moved	0	1
Lost to Follow-up	1	3
Death	16	26
[1] Completed = participants who fully completed 12 cycles of treatment; [2] Participants ongoing at data cut-off date

Baseline Characteristics

Arm/Group Title		Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo	Total
Arm/Group Description		Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.	Total of all reporting groups
Overall Number of Baseline Participants		178	180	358
Baseline Analysis Population Description		The intent to treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received investigational product (IP) or not.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	178 participants	180 participants	358 participants
		62.30 (11.227)	61.48 (11.160)	61.89 (11.186)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	Female	103 57.9%	83 46.1%	186 52.0%
	Male	75 42.1%	97 53.9%	172 48.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	White	118 66.3%	115 63.9%	233 65.1%
	Other Races	54 30.3%	64 35.6%	118 33.0%
	Not Collected or Reported	6 3.4%	1 0.6%	7 2.0%
Ann Arbor Stage at Enrollment [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	Stage I	15 8.4%	18 10.0%	33 9.2%
	Stage II	26 14.6%	38 21.1%	64 17.9%
	Stage III	73 41.0%	65 36.1%	138 38.5%
	Stage IV	64 36.0%	59 32.8%	123 34.4%
		[1] Measure Description: Ann Arbor staging is the staging system for lymphomas. The stage depends on both the place where the malignant tissue is located and on systemic symptoms ("B symptoms": night sweats, weight loss of >10% or fevers). The Stages include: I: Involvement of a single lymph node (LN) region II: Involvement of 2 or more LN on the same side of the diaphragm III: Involvement of LN regions on both sides of the diaphragm IV: Multifocal involvement of ≥ 1 extralymphatic sites with or without associated LN involvement or isolated extralymphatic organ involvement with distant (non regional) nodal involvement
Follicular Lymphoma International Prognostic Index (FLIPI) category [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	Low (0,1)	52 29.2%	67 37.2%	119 33.2%
	Intermediate (2)	55 30.9%	58 32.2%	113 31.6%
	High (≥3)	69 38.8%	54 30.0%	123 34.4%
	Missing	2 1.1%	1 0.6%	3 0.8%
		[1] Measure Description: A FLIPI score of 0 to 1 is considered “low risk” with a 10 year overall survival of 70%. A score of 2 is considered “intermediate risk” with a 10 year overall survival of 50%. Finally, a score of ≥ 3 is considered “high risk” with a 10 year overall survival of 35%.
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	0 (Fully Active)	116 65.2%	128 71.1%	244 68.2%
	1 (Restrictive but ambulatory)	60 33.7%	50 27.8%	110 30.7%
	2 (Ambulatory but unable to work)	2 1.1%	2 1.1%	4 1.1%
	3 (Limited self-care)	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: ECOG Performance Status is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient and determine appropriate treatment and prognosis.
Histology [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	Follicular Lymphoma (FL)	147 82.6%	148 82.2%	295 82.4%
	Marginal Zone Lymphoma (MZL)	31 17.4%	32 17.8%	63 17.6%
		[1] Measure Description: Histology refers to the study of the anatomy of cells and tissues at the microscopic level.
Histology By Central Pathology Review [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	Follicular Lymphoma	129 72.5%	137 76.1%	266 74.3%
	Marginal Zone Lymphoma	26 14.6%	27 15.0%	53 14.8%
	Unclear/ Other Histology	5 2.8%	3 1.7%	8 2.2%
	Inadequate Sample	13 7.3%	11 6.1%	24 6.7%
	No Central Pathology Review	5 2.8%	2 1.1%	7 2.0%
		[1] Measure Description: Histology refers to the study of the anatomy of cells and tissues at the microscopic level.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	178 participants	180 participants	358 participants
	United States	23 12.9%	17 9.4%	40 11.2%
	Europe	81 45.5%	84 46.7%	165 46.1%
	Asia Pacific and Brazil	74 41.6%	79 43.9%	153 42.7%

Outcome Measures

1. Primary Outcome

Title	Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)
Description	Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.
Time Frame	From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Median (95% Confidence Interval); Unit of Measure: months
	39.4 [1]; (22.9 to NA)	14.1; (11.4 to 16.7)

[1]

NA =Not enough events had occurred at the time of the data cut-off date

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.46
	Confidence Interval	(2-Sided) 95%; 0.34 to 0.62
	Estimation Comments	Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.

2. Secondary Outcome

Title	Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC
Description	DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.
Time Frame	From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	25.3; (19.1 to 32.3)	11.1; (6.9 to 16.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).

3. Secondary Outcome

Title	Kaplan-Meier Estimate of Overall Survival (OS)
Description	Overall survival 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 were lost to follow-up before death was documented.
Time Frame	From the date of randomization to the cut-off date of 22 June 2018; The overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months)

Outcome Measure Data

Analysis Population Description

The ITT population is defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

NA = not estimable because the median for OS had not been reached at the date of the data cut-off.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.61
	Confidence Interval	(2-Sided) 95%; 0.33 to 1.13
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC
Description	Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (PR) = 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
Time Frame	From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	77.5; (70.7 to 83.4)	53.3; (45.8 to 60.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).

5. Secondary Outcome

Title	Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC
Description	Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.
Time Frame	From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	33.7; (26.8 to 41.2)	18.3; (13.0 to 24.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	= 0.0010
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).

6. Secondary Outcome

Title	Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC
Description	Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed 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 participants was known to be progression free.
Time Frame	From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Outcome Measure Data

Analysis Population Description

Participants who achieved an objective response in the ITT population.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	138	96
Median (95% Confidence Interval); Unit of Measure: months
	36.6 [1]; (22.9 to NA)	21.7; (12.8 to 27.6)

[1]

Not estimable as not enough events had occurred at the time of the data cut-off date

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0015
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; 0.36 to 0.79
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC
Description	DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed 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 participants was known to be progression free.
Time Frame	From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Outcome Measure Data

Analysis Population Description

Participants who achieved a complete response in the ITT population.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	60	33
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (25.3 to NA)	NA [1]; (13.8 to NA)

[1]

Not enough events had occurred at the time of the data cut-off date

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2993
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.32 to 1.43
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC
Description	Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.
Time Frame	From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Median (95% Confidence Interval); Unit of Measure: months
	27.6 [1]; (22.1 to NA)	13.9; (11.4 to 16.7)

[1]

Not enough events had occurred at the time of the data cut-off date

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Stratified Log-Rank Test
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.67
	Estimation Comments	Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.

9. Secondary Outcome

Title	Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
Description	Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.
Time Frame	From randomization to data cut off of 22 Jun 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).

Outcome Measure Data

Analysis Population Description

The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	178	180
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	32.2 [2]; (23.2 to NA)

[1]

Not estmable due to the low number of events at the time of the data cut-off date.

[2]

The upper limit was not estmable due to the low number of events at the time of the data cut-off date.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rituximab Plus Lenalidomide (R^2), Rituximab Plus Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0007
	Comments	[Not Specified]
	Method	Stratified Log Rank Test
	Comments	Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; 0.38 to 0.78
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description	TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any: Death;; Life-threatening event;; Any inpatient hospitalization or prolongation of existing hospitalization;; Persistent or significant disability or incapacity;; Congenital anomaly or birth defect;; Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death
Time Frame	From the first dose of study drug up to 28 days after the last dose of IP and those SAEs made known at any time; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who have received at least one dose of study medication.

Arm/Group Title	Rituximab Plus Lenalidomide (R^2)	Rituximab Plus Placebo
Arm/Group Description:	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
Overall Number of Participants Analyzed	176	180
Measure Type: Count of Participants; Unit of Measure: Participants
Any TEAE	174 98.9%	173 96.1%
Any TEAE Related To Lenalidomide/Placebo (LEN/PBO)	159 90.3%	118 65.6%
Any TEAE Related To Rituximab (RIT)	132 75.0%	105 58.3%
Any SAE	45 25.6%	25 13.9%
Any SAE Related to LEN/PBO	23 13.1%	8 4.4%
Any SAE Related to RIT	13 7.4%	3 1.7%
Any CTCAE Grade (GR) 3/4 TEAE	121 68.8%	58 32.2%
Any CTCAE GR 3/4 TEAE Related to LEN/PBO	101 57.4%	38 21.1%
Any CTCAE GR 3/4 TEAE Related to RIT	57 32.4%	19 10.6%
Any GR 5 TEAE	2 1.1%	2 1.1%
Any TEAE Leading To Dose Reduction LEN/PBO	46 26.1%	6 3.3%
Any TEAE Leading To Dose Interruption LEN/PBO	112 63.6%	47 26.1%
Any TEAE Leading To Dose Interruption RIT	60 34.1%	37 20.6%
Any TEAE Leading To Discontinuation of LEN/PBO	15 8.5%	9 5.0%
Any TEAE Leading To Discontinuation of RIT	6 3.4%	2 1.1%

Adverse Events

Time Frame	From the date of the first dose of study drug up to 28 days after the last dose of IP and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. AEs collected and monitored up to the data cut off date of 22 June 2018.
Adverse Event Reporting Description	The median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm
Arm/Group Title	Rituximab and Lenalidomide	Rituximab and Placebo
Arm/Group Description	Participants received rituximab 375 mg/m^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but < 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.	Participants received rituximab 375 mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
All-Cause Mortality
	Rituximab and Lenalidomide	Rituximab and Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	16/176 (9.09%)	26/180 (14.44%)
Serious Adverse Events
	Rituximab and Lenalidomide	Rituximab and Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	45/176 (25.57%)	25/180 (13.89%)
Blood and lymphatic system disorders
Anaemia † 1	2/176 (1.14%)	0/180 (0.00%)
Febrile neutropenia † 1	5/176 (2.84%)	0/180 (0.00%)
Leukopenia † 1	1/176 (0.57%)	0/180 (0.00%)
Neutropenia † 1	3/176 (1.70%)	0/180 (0.00%)
Pancytopenia † 1	1/176 (0.57%)	0/180 (0.00%)
Cardiac disorders
Angina pectoris † 1	1/176 (0.57%)	0/180 (0.00%)
Arrhythmia † 1	1/176 (0.57%)	0/180 (0.00%)
Atrial fibrillation † 1	1/176 (0.57%)	2/180 (1.11%)
Atrial flutter † 1	0/176 (0.00%)	1/180 (0.56%)
Cardiopulmonary failure † 1	1/176 (0.57%)	0/180 (0.00%)
Myocardial infarction † 1	0/176 (0.00%)	1/180 (0.56%)
Supraventricular tachycardia † 1	2/176 (1.14%)	0/180 (0.00%)
Ear and labyrinth disorders
Vertigo † 1	1/176 (0.57%)	0/180 (0.00%)
Eye disorders
Retinal detachment † 1	0/176 (0.00%)	1/180 (0.56%)
Gastrointestinal disorders
Diarrhoea † 1	1/176 (0.57%)	0/180 (0.00%)
Faecaloma † 1	1/176 (0.57%)	0/180 (0.00%)
Haemorrhagic erosive gastritis † 1	0/176 (0.00%)	1/180 (0.56%)
Haemorrhoids † 1	0/176 (0.00%)	1/180 (0.56%)
Volvulus † 1	1/176 (0.57%)	0/180 (0.00%)
General disorders
Asthenia † 1	0/176 (0.00%)	1/180 (0.56%)
Fatigue † 1	0/176 (0.00%)	1/180 (0.56%)
General physical health deterioration † 1	2/176 (1.14%)	1/180 (0.56%)
Localised oedema † 1	0/176 (0.00%)	1/180 (0.56%)
Oedema peripheral † 1	1/176 (0.57%)	1/180 (0.56%)
Pyrexia † 1	3/176 (1.70%)	0/180 (0.00%)
Hepatobiliary disorders
Cholecystitis † 1	1/176 (0.57%)	0/180 (0.00%)
Cholelithiasis † 1	0/176 (0.00%)	1/180 (0.56%)
Immune system disorders
Anaphylactic shock † 1	1/176 (0.57%)	0/180 (0.00%)
Infections and infestations
Appendicitis † 1	1/176 (0.57%)	1/180 (0.56%)
Cellulitis † 1	1/176 (0.57%)	0/180 (0.00%)
Diverticulitis † 1	1/176 (0.57%)	0/180 (0.00%)
Gastroenteritis † 1	1/176 (0.57%)	0/180 (0.00%)
Herpes zoster † 1	0/176 (0.00%)	1/180 (0.56%)
Lung infection † 1	1/176 (0.57%)	1/180 (0.56%)
Neurosyphilis † 1	1/176 (0.57%)	0/180 (0.00%)
Pneumonia † 1	5/176 (2.84%)	5/180 (2.78%)
Pneumonia influenzal † 1	1/176 (0.57%)	0/180 (0.00%)
Pyelonephritis † 1	1/176 (0.57%)	0/180 (0.00%)
Pyelonephritis acute † 1	1/176 (0.57%)	0/180 (0.00%)
Respiratory tract infection † 1	1/176 (0.57%)	0/180 (0.00%)
Sepsis † 1	3/176 (1.70%)	2/180 (1.11%)
Septic shock † 1	0/176 (0.00%)	1/180 (0.56%)
Sialoadenitis † 1	1/176 (0.57%)	0/180 (0.00%)
Upper respiratory tract infection † 1	0/176 (0.00%)	2/180 (1.11%)
Urinary tract infection † 1	1/176 (0.57%)	1/180 (0.56%)
Injury, poisoning and procedural complications
Fall † 1	1/176 (0.57%)	0/180 (0.00%)
Femur fracture † 1	1/176 (0.57%)	0/180 (0.00%)
Infusion related reaction † 1	2/176 (1.14%)	0/180 (0.00%)
Lower limb fracture † 1	1/176 (0.57%)	0/180 (0.00%)
Rib fracture † 1	1/176 (0.57%)	0/180 (0.00%)
Spinal compression fracture † 1	1/176 (0.57%)	0/180 (0.00%)
Traumatic fracture † 1	0/176 (0.00%)	1/180 (0.56%)
Metabolism and nutrition disorders
Dehydration † 1	0/176 (0.00%)	1/180 (0.56%)
Musculoskeletal and connective tissue disorders
Pain in extremity † 1	1/176 (0.57%)	0/180 (0.00%)
Seronegative arthritis † 1	1/176 (0.57%)	0/180 (0.00%)
Spinal pain † 1	1/176 (0.57%)	0/180 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	0/176 (0.00%)	1/180 (0.56%)
Invasive ductal breast carcinoma † 1	0/176 (0.00%)	1/180 (0.56%)
Malignant melanoma † 1	0/176 (0.00%)	1/180 (0.56%)
Squamous cell carcinoma of skin † 1	2/176 (1.14%)	0/180 (0.00%)
Transitional cell cancer of the renal pelvis and ureter localised † 1	0/176 (0.00%)	1/180 (0.56%)
Tumour flare † 1	1/176 (0.57%)	0/180 (0.00%)
Nervous system disorders
Cerebrovascular accident † 1	1/176 (0.57%)	1/180 (0.56%)
Syncope † 1	0/176 (0.00%)	2/180 (1.11%)
Transient ischaemic attack † 1	0/176 (0.00%)	2/180 (1.11%)
Renal and urinary disorders
Acute kidney injury † 1	2/176 (1.14%)	0/180 (0.00%)
Haematuria † 1	0/176 (0.00%)	1/180 (0.56%)
Renal colic † 1	0/176 (0.00%)	1/180 (0.56%)
Reproductive system and breast disorders
Adnexal torsion † 1	0/176 (0.00%)	1/180 (0.56%)
Respiratory, thoracic and mediastinal disorders
Acute lung injury † 1	1/176 (0.57%)	0/180 (0.00%)
Asthmatic crisis † 1	1/176 (0.57%)	0/180 (0.00%)
Chronic obstructive pulmonary disease † 1	1/176 (0.57%)	0/180 (0.00%)
Dyspnoea † 1	1/176 (0.57%)	1/180 (0.56%)
Pleural effusion † 1	1/176 (0.57%)	3/180 (1.67%)
Pulmonary embolism † 1	4/176 (2.27%)	1/180 (0.56%)
Respiratory failure † 1	2/176 (1.14%)	0/180 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus generalised † 1	1/176 (0.57%)	0/180 (0.00%)
Rash maculo-papular † 1	1/176 (0.57%)	0/180 (0.00%)
Vascular disorders
Deep vein thrombosis † 1	1/176 (0.57%)	0/180 (0.00%)
Lymphoedema † 1	1/176 (0.57%)	0/180 (0.00%)
Peripheral arterial occlusive disease † 1	0/176 (0.00%)	1/180 (0.56%)
1 Term from vocabulary, MedDRA 21.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Rituximab and Lenalidomide	Rituximab and Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	170/176 (96.59%)	160/180 (88.89%)
Blood and lymphatic system disorders
Anaemia † 1	28/176 (15.91%)	8/180 (4.44%)
Leukopenia † 1	36/176 (20.45%)	17/180 (9.44%)
Lymphopenia † 1	8/176 (4.55%)	14/180 (7.78%)
Neutropenia † 1	102/176 (57.95%)	40/180 (22.22%)
Thrombocytopenia † 1	26/176 (14.77%)	8/180 (4.44%)
Gastrointestinal disorders
Abdominal pain † 1	22/176 (12.50%)	16/180 (8.89%)
Abdominal pain upper † 1	12/176 (6.82%)	7/180 (3.89%)
Constipation † 1	46/176 (26.14%)	25/180 (13.89%)
Diarrhoea † 1	55/176 (31.25%)	41/180 (22.78%)
Dyspepsia † 1	16/176 (9.09%)	5/180 (2.78%)
Nausea † 1	20/176 (11.36%)	23/180 (12.78%)
Stomatitis † 1	9/176 (5.11%)	7/180 (3.89%)
Vomiting † 1	17/176 (9.66%)	13/180 (7.22%)
General disorders
Asthenia † 1	24/176 (13.64%)	18/180 (10.00%)
Chills † 1	14/176 (7.95%)	8/180 (4.44%)
Fatigue † 1	38/176 (21.59%)	33/180 (18.33%)
Influenza like illness † 1	9/176 (5.11%)	7/180 (3.89%)
Malaise † 1	13/176 (7.39%)	10/180 (5.56%)
Oedema peripheral † 1	23/176 (13.07%)	15/180 (8.33%)
Pyrexia † 1	36/176 (20.45%)	27/180 (15.00%)
Infections and infestations
Influenza † 1	17/176 (9.66%)	8/180 (4.44%)
Nasopharyngitis † 1	13/176 (7.39%)	18/180 (10.00%)
Pneumonia † 1	11/176 (6.25%)	1/180 (0.56%)
Sinusitis † 1	13/176 (7.39%)	5/180 (2.78%)
Upper respiratory tract infection † 1	32/176 (18.18%)	22/180 (12.22%)
Urinary tract infection † 1	12/176 (6.82%)	7/180 (3.89%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	25/176 (14.20%)	24/180 (13.33%)
Investigations
Alanine aminotransferase increased † 1	18/176 (10.23%)	15/180 (8.33%)
Aspartate aminotransferase increased † 1	9/176 (5.11%)	9/180 (5.00%)
Blood bilirubin increased † 1	10/176 (5.68%)	0/180 (0.00%)
Lymphocyte count decreased † 1	12/176 (6.82%)	12/180 (6.67%)
Weight decreased † 1	12/176 (6.82%)	2/180 (1.11%)
White blood cell count decreased † 1	16/176 (9.09%)	13/180 (7.22%)
Metabolism and nutrition disorders
Decreased appetite † 1	23/176 (13.07%)	11/180 (6.11%)
Hyperglycaemia † 1	11/176 (6.25%)	11/180 (6.11%)
Hyperuricaemia † 1	10/176 (5.68%)	8/180 (4.44%)
Hypokalaemia † 1	14/176 (7.95%)	5/180 (2.78%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	15/176 (8.52%)	14/180 (7.78%)
Back pain † 1	14/176 (7.95%)	18/180 (10.00%)
Muscle spasms † 1	23/176 (13.07%)	9/180 (5.00%)
Myalgia † 1	10/176 (5.68%)	12/180 (6.67%)
Pain in extremity † 1	8/176 (4.55%)	9/180 (5.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare † 1	18/176 (10.23%)	1/180 (0.56%)
Nervous system disorders
Dizziness † 1	15/176 (8.52%)	9/180 (5.00%)
Headache † 1	26/176 (14.77%)	17/180 (9.44%)
Psychiatric disorders
Insomnia † 1	14/176 (7.95%)	11/180 (6.11%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	40/176 (22.73%)	31/180 (17.22%)
Dyspnoea † 1	18/176 (10.23%)	7/180 (3.89%)
Oropharyngeal pain † 1	10/176 (5.68%)	8/180 (4.44%)
Productive cough † 1	12/176 (6.82%)	8/180 (4.44%)
Skin and subcutaneous tissue disorders
Dry skin † 1	9/176 (5.11%)	6/180 (3.33%)
Pruritus † 1	21/176 (11.93%)	7/180 (3.89%)
Pruritus generalised † 1	14/176 (7.95%)	3/180 (1.67%)
Rash † 1	19/176 (10.80%)	7/180 (3.89%)
Rash maculo-papular † 1	14/176 (7.95%)	4/180 (2.22%)
Vascular disorders
Hypertension † 1	6/176 (3.41%)	11/180 (6.11%)
Hypotension † 1	9/176 (5.11%)	1/180 (0.56%)
1 Term from vocabulary, MedDRA 21.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.

Results Point of Contact

• Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporationi
• Phone: 888-260-1599
• EMail: ClinicalTrialDisclosure@Celgene.com

Publications of Results:

Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabeçadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT01938001 History of Changes
• Other Study ID Numbers: CC-5013-NHL-007
• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Results First Submitted: June 21, 2019
• Results First Posted: August 13, 2019
• Last Update Posted: August 13, 2019