Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance
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|ClinicalTrials.gov Identifier: NCT03731234|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : December 28, 2020
This is a prospective, multicenter, single arm, phase II trial in patients with ≥ 18 and <80 years with poor-prognosis (IPI ≥ 2) and newly diagnosed ABC-DLBCL.
Aim of the study is to assess the efficacy and the safety of R-CHOP in combination with ibrutinib for 6 cycles followed by ibrutinib maintenance for 18 months in ABC-DLBCL patients achieving at least a PR after the induction phase
|Condition or disease||Intervention/treatment||Phase|
|DLBCL||Drug: Ibrutinib||Phase 2|
Step 1 - Screening phase If central review will confirm and define the diagnosis of ABC-DLBCL according the COO, eligible patients will have to sign an additional informed consent prior to receive the study subsequent treatment.
Step 2 - study treatment phases Induction phase: 5 courses of R-CHOP every 21 days combined with ibrutinib (560 mg/day, continuously).
Maintenance phase: patients achieving a CR or a PR after 5 courses of RI-CHOP21 will enter the maintenance phase with ibrutinib (560 mg/day, continuously) for 18 months.
Radiotherapy could be delivered as consolidation treatment at the end of R-chemotherapy, according to Institution local clinical practice, in patients with focal PET positive residual disease and to bone extranodal lesions or scrotum, if testicular involvement irrespective of initial tumor diameter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multicenter Single Arm Study to Evaluate the Efficacy and Safety of Ibrutinib in Combination to Rituximab-CHOP Followed by Ibrutinib Maintenance in Untreated Patients With Activated-B-Cell (ABC)-DLBCL at Intermediate-high and High Risk (IPI ≥2)|
|Actual Study Start Date :||July 2, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2025|
Screening phase for selection of Activated-B-Cell (ABC)-DLBCL Induction phase: R-CHOP21 x 5 cycles in combination with ibrutinib Maintenance phase: maintenance with Ibrutinib for 18 months for patients responding to the induction phase (CR or PR)
Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance
Other Name: IMBRUVICA (commercial name)
- Progression-free survival (PFS) (1st time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (24 months) ]PFS of the high/high-intermediate risk patients from date of enrolment
- Progression-free survival (PFS) (2nd time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (36 months) ]PFS of the high/high-intermediate risk patients from date of enrolment
- Progression-free survival (PFS) (3dr time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (48 months) ]PFS of the high/high-intermediate risk patients from date of enrolment
- Overall Survival (OS) [ Time Frame: Time between the date of enrolment and the date of death from any cause (24, 36 and 48 months). ]Overall Survival
- Complete response and Overall Response (CR+PR) rate at the end of induction [ Time Frame: End of induction (EOI) (4 months) ]Complete response and Overall Response
- Duration of response (DOR) [ Time Frame: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date) ]Duration of response
- Complete remission (CRR) after ibrutinib maintenance [ Time Frame: End of treatment (EOT) (up to 24 months) ]Complete remission after ibrutinib maintenance
- Event Free Survival (EFS) [ Time Frame: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months) ]Event Free Survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731234
|Contact: Maurizio Martelli, Proffirstname.lastname@example.org|
|Principal Investigator:||Maurizio Martelli, Prof.||Dipartimento di Medicina Traslazionale e di Precisione, Università 'La Sapienza'|