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A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial (EMERGE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT00737529
First received: August 15, 2008
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

Condition Intervention Phase
Mantle Cell Lymphoma Drug: lenalidomide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Refractory To Bortezomib

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Percentage of Participants With an Overall Response [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    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 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

  • Duration of Response (DoR) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles and/or data cut-off of 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Kaplan Meier estimates for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.


Secondary Outcome Measures:
  • Time to Response (TTR) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    TTR was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.

  • Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; Data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other antilymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. 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; Non-responders are participants who discontinue before any post-baseline efficacy assessments.

  • Duration of Complete Response (DoCR) (CR+CRu) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.

  • Time to Complete Response (CR+CRu) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.

  • Time to Progression (TTP) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir

  • Time to Treatment Failure (TTF) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.

  • Progression-free Survival (PFS) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; and/or of the data-cut off of 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate 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 adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.

  • Overall Survival (OS) [ Time Frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks ]
    Kaplan Meier estimates of OS was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.

  • Summary of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From the first dose of Lenalidomide through cycle 6 plus 28 days of last dose of Lenalidomide (maximum duration of study drug was 1006 days) and up to data cut off 02 July 2012 ]
    Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: Following is the scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.


Enrollment: 134
Study Start Date: December 2008
Estimated Study Completion Date: August 16, 2017
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide

Single agent Lenalidomide

Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.

Drug: lenalidomide
25mg oral capsules continuous days 1-21 each of a 28 day cycle
Other Name: Revlimid

Detailed Description:

Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation.

Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven mantle cell lymphoma
  • Patients must have documents relapsed, refractory or PD after treatment with bortezomib
  • Must have measureable disease on cross sectional imaging by CT
  • Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
  • Willing to follow pregnancy precautions

Exclusion Criteria:

  • Any of the following laboratory abnormalities

    • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
    • Platelet count < 60,000/mm3 (60 x 109/L)
    • Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
    • Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
    • Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min
    • Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
    • History of active central nervous system (CNS) lymphoma within the previous 3 months
    • Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
    • Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
    • Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737529

  Show 70 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Lei Zhang, MD Celgene Corporation
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00737529     History of Changes
Other Study ID Numbers: CC-5013-MCL-001
Study First Received: August 15, 2008
Results First Received: June 28, 2013
Last Updated: June 29, 2017

Keywords provided by Celgene:
Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
CC-5013
Revlimid
Lenalidomide

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Bortezomib
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017