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出境医 / 临床实验 / Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

Study Description
Brief Summary:
This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Ibrutinib Drug: Lenalidomide Drug: Rituximab Phase 2

Detailed Description:
This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: iR2
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
 Drug: Ibrutinib
Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
Other Name: Imbruvica

Drug: Lenalidomide
Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
Other Name: Relvimid

Drug: Rituximab
Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
Other Name: Rituxan
Outcome Measures
Primary Outcome Measures :
  1. Complete response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria

  2. Progression free survival [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

  3. Overall survival [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.

  4. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.


Other Outcome Measures:
  1. Circulating free Deoxyribonucleic Acid (cfDNA) monitoring [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    cfDNA in peripheral blood assessed by local lab


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed diffuse large B cell lymphoma, treatment naive
  2. Age > 75 years
  3. Ineligible for standard chemotherapy
  4. Must has measurable lesion in CT or PET-CT prior to treatment
  5. At least 3 months life expectation
  6. Informed consented
  7. No previous use of study drug

Exclusion Criteria:

  1. Has accepted Chemotherapy before
  2. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  3. Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<80*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
  4. Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
  5. HIV infection
  6. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
  7. Other uncontrollable medical condition that may that may interfere the participation of the study
Contacts and Locations

Locations
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China, Shanghai
Ruijin hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Study Chair: Weili Zhao, PhD Ruijin Hospital
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE March 13, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019) 		Complete response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Overall response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria
  • Progression free survival [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
  • Overall survival [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.
  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2019) 		Circulating free Deoxyribonucleic Acid (cfDNA) monitoring [ Time Frame: Baseline up to data cut-off (up to approximately 4 years) ]
cfDNA in peripheral blood assessed by local lab
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL
Official Title  ICMJE A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma
Brief Summary This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。
Detailed Description This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B Cell Lymphoma
Intervention  ICMJE
  • Drug: Ibrutinib
    Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
    Other Name: Imbruvica
  • Drug: Lenalidomide
    Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
    Other Name: Relvimid
  • Drug: Rituximab
    Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
    Other Name: Rituxan
Study Arms  ICMJE Experimental: iR2
Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
Interventions:
  • Drug: Ibrutinib
  • Drug: Lenalidomide
  • Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 15, 2021) 		30
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2019) 		20
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pathologically confirmed diffuse large B cell lymphoma, treatment naive
  2. Age > 75 years
  3. Ineligible for standard chemotherapy
  4. Must has measurable lesion in CT or PET-CT prior to treatment
  5. At least 3 months life expectation
  6. Informed consented
  7. No previous use of study drug

Exclusion Criteria:

  1. Has accepted Chemotherapy before
  2. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  3. Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<80*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
  4. Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
  5. HIV infection
  6. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
  7. Other uncontrollable medical condition that may that may interfere the participation of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949062
Other Study ID Numbers  ICMJE NHL-iR2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhao Weili, Ruijin Hospital
Study Sponsor  ICMJE Ruijin Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Weili Zhao, PhD Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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