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

Diffuse Large B Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03949062
• Other study ID #: NHL-iR2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 13, 2019
• Est. completion date: May 2022

Study information

• Verified date: February 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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。

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Ibrutinib
Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
• Lenalidomide
Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
• Rituximab
Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles

Locations

Country	Name	City	State
China	Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Circulating free Deoxyribonucleic Acid (cfDNA) monitoring	cfDNA in peripheral blood assessed by local lab	Baseline up to data cut-off (up to approximately 4 years)
Primary	Complete response rate	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria	At the end of Cycle 6 (each cycle is 21 days)
Secondary	Overall response rate	Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria	At the end of Cycle 6 (each cycle is 21 days)
Secondary	Progression free survival	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.	Baseline up to data cut-off (up to approximately 4 years)
Secondary	Overall survival	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.	Baseline up to data cut-off (up to approximately 4 years)
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	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.	Baseline up to data cut-off (up to approximately 4 years)