EVALUATION OF EFFICACY AND SAFETY OF OBINUTUZUMAB PREEMPTIVE TREATMENT AT THE TIME OF THE MOLECULAR RELAPSE AFTER FIRST LINE IMMUNOCHEMOTHERAPY WITH AUTOLOGOUS STEM CELL TRANSPLANTATION IN MANTLE CELL LYMPHOMA PATIENTS. OPERA PLRG-10 TRIAL (ML29157)

EVALUATION OF EFFICACY AND SAFETY OF OBINUTUZUMAB PREEMPTIVE TREATMENT AT THE TIME OF THE MOLECULAR RELAPSE AFTER FIRST LINE IMMUNOCHEMOTHERAPY WITH AUTOLOGOUS STEM CELL TRANSPLANTATION IN MANTLE CELL LYMPHOMA PATIENTS. OPERA PLRG-10 TRIAL (ML29157) - OPERA PLRG-10 TRIAL (ML29157)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005439-41-PL

Enrollment

Registered

2017-06-27

Start date

2017-08-13

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molecular relapse after the first line immunochemotherapy with autologous stem cell transplantation in mantle cell lymphoma (MCL) patients MedDRA version: 20.0 Level: PT Classification code 10061275 Term: Mantle cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Gazyvaro 1,000 mg concentrate for solution for infusion. Product Name: obinutuzumab (Gazyvaro) Product Code: GA101 Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with evidence of MCL molecular relapse in peripheral blood or/and bone marrow - Diagnosis of mantle cell lymphoma confirmed by histopathology [if necessary, confirmed by FISH (CCND1)] - Presence of clone-specific immunoglobulin heavy chain (IGH) gene rearrangements or BCL1-IGH fusion gene as a molecular marker used for minimal residual disease (MRD) assessment - Patients who achieved a molecular remission after first-line treatment with myeloablative consolidation and ASCT - Patients without evidence of mantle cell lymphoma progression/relapse according to the Lugano Classification criteria (2014) - ECOG performance status = 2 - Signed patient’s informed consent form - Survival prognosis > 6 months - Women of childbearing potential must have a negative pregnancy test result prior to initiation of treatment with the study medication and must consent to undergo pregnancy tests during the treatment period. - Women of child-bearing potential must consent either to sexual abstinence or to using effective contraception (that results in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Central nervous system involvement - Chemotherapy, radiation therapy or any other antineoplastic treatment (including steroids, monoclonal antibodies or medications at the stage of clinical studies, before receiving marketing authorization) after ASCT and before administration of the study medication - Major surgery within 28 days prior to the study treatment initiation - Renal impairment (plasma creatinine concentration > 1.5 × upper limit of normal and/or creatinine clearance = 40 ml/min) - Hepatic impairment (total bilirubin concentration > 1.5 × upper limit of normal, AST and ALT > 2.5 × upper limit of normal) - Hb 1.5 - Clinically significant heart disease, including uncontrolled arrhythmias, unstable coronary artery disease, serious congestive circulatory failure (NYHA III–IV), myocardial infarction within 6 months before enrolment - Other comorbidities, not responding to treatment, including, but not limited to: hematopoietic system diseases, gastrointestinal system diseases, endocrine system diseases, respiratory system diseases, neurological diseases, cerebral diseases and mental diseases that could affect compliance with the protocol or interpretation of results - Active infections (viral, bacterial, fungal) - Coexistence of another neoplasm or a history of neoplastic disease (except for adequately treated basal cell carcinoma or squamous cell skin carcinoma, in situ cervical cancer or other neoplasm if the patient is in complete remission after at least 5 years of treatment discontinuation) - Active HIV, HBV or HCV infection - Positive test results for chronic hepatitis B. All patients must be tested for both HBsAg and HBcAb at screening, if either of the tests is positive, the patient is not eligible for inclusion in the trial. Patients who have protective titers of HBsAb after vaccination are eligible provided they are negative for both HBsAg and HBcAb - Positive testing for hepatitis C (hepatitis C virus [HCV] antibody serology testing). Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA - Vaccination with live vaccines within 28 days prior to start of the preemptive treatment - Known or suspected hypersensitivity to the study medication - Women who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Main Objective: The objective of the study is the evaluation of efficacy and safety of obinutuzumab preemptive treatment at the time of the molecular relapse after first line immunochemotherapy with autologous stem cell transplantation in mantle cell lymphoma patients. Primary: Molecular response rate (molRR) defined as a rate of molecular response with at least 10-4 sensitivity level assessed by quantitative RQ-PCR. at 2 months after obinutuzumab treatment Definition of molecular response: MRD negativity defined as a MRD level = 10-4 by quantitative RQ-PCR assay with a sensitivity of at least 10-4.;Secondary Objective: Secondary: - Progression-free survival (PFS) - Time to molecular relapse - Overall survival (OS) - Time to relapse/progression - Event-free survival (EFS) - Health status measured with EQ-5D from EuroQoL Group - Treatment tolerability assessment ;Primary end point(s): Primary: - Molecular response rate (molRR) defined as a rate of molecular response with at least 10-4 sensitivity level assessed by quantitative RQ-PCR. at 2 months after obinutuzumab treatment Definition of molecular response: MRD negativity defined as a MRD level = 10-4 by quantitative RQ-PCR assay with a sensitivity of at least 10-4.;Timepoint(s) of evaluation of this end point: The primary analysis of primary end point is expected to be performed approximately 2 month after the last patient received the last dose of the study treatment. It will be performed after the molecular response of the last patient has been assessed.	—

Measure

Time frame

Main Objective: Main Objective: The objective of the study is the evaluation of efficacy and safety of obinutuzumab preemptive treatment at the time of the molecular relapse after first line immunochemotherapy with autologous stem cell transplantation in mantle cell lymphoma patients. Primary: Molecular response rate (molRR) defined as a rate of molecular response with at least 10-4 sensitivity level assessed by quantitative RQ-PCR. at 2 months after obinutuzumab treatment Definition of molecular response: MRD negativity defined as a MRD level = 10-4 by quantitative RQ-PCR assay with a sensitivity of at least 10-4.;Secondary Objective: Secondary: - Progression-free survival (PFS) - Time to molecular relapse - Overall survival (OS) - Time to relapse/progression - Event-free survival (EFS) - Health status measured with EQ-5D from EuroQoL Group - Treatment tolerability assessment ;Primary end point(s): Primary: - Molecular response rate (molRR) defined as a rate of molecular response with at least 10-4 sensitivity level assessed by quantitative RQ-PCR. at 2 months after obinutuzumab treatment Definition of molecular response: MRD negativity defined as a MRD level = 10-4 by quantitative RQ-PCR assay with a sensitivity of at least 10-4.;Timepoint(s) of evaluation of this end point: The primary analysis of primary end point is expected to be performed approximately 2 month after the last patient received the last dose of the study treatment. It will be performed after the molecular response of the last patient has been assessed.

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Secondary

Measure	Time frame
Secondary end point(s): - Progression-free survival (PFS) defined as the time from the date of the first obinutuzumab infusion to disease progression or relapse, as determined by the investigator using the Lugano Classification or death from any cause after the last dose of study drug) - Time to molecular relapse defined as the time from the date of the first obinutuzumab infusion to the first occurrence of molecular disease relapse, assessed in the subgroup achieving a molecular response Definition of molecular relapse: MRD level above 10-4 in two consecutive bone marrow or peripheral blood samples is defined as a molecular relapse. - Overall survival (OS) defined as the time from the date of the initiation of the first line treatment to the death from any reason - Time to relapse/progression defined as the time from the date of the first obinutuzumab infusion to the first evidence of disease progression or relapse, as determined by the investigator using the Lugano Classification - Event-free survival (EFS) defined as the time from the date of the first obinutuzumab infusion to the first evidence of disease progression or relapse (as determined by the investigator using the Lugano Classification), death from any reason, start of the another anti-lymphoma treatment, SAE preventing continuation of the protocol treatment - Health status measured with EQ-5D from EuroQoL Group - Treatment tolerability assessment — reporting of serious adverse events (SAEs), adverse events (AEs) and adverse events of special interest. ;Timepoint(s) of evaluation of this end point: The final analysis will be performed 3 years and 2 months after the last patient has signed the ICF.	—

Measure

Time frame

Secondary end point(s): - Progression-free survival (PFS) defined as the time from the date of the first obinutuzumab infusion to disease progression or relapse, as determined by the investigator using the Lugano Classification or death from any cause after the last dose of study drug) - Time to molecular relapse defined as the time from the date of the first obinutuzumab infusion to the first occurrence of molecular disease relapse, assessed in the subgroup achieving a molecular response Definition of molecular relapse: MRD level above 10-4 in two consecutive bone marrow or peripheral blood samples is defined as a molecular relapse. - Overall survival (OS) defined as the time from the date of the initiation of the first line treatment to the death from any reason - Time to relapse/progression defined as the time from the date of the first obinutuzumab infusion to the first evidence of disease progression or relapse, as determined by the investigator using the Lugano Classification - Event-free survival (EFS) defined as the time from the date of the first obinutuzumab infusion to the first evidence of disease progression or relapse (as determined by the investigator using the Lugano Classification), death from any reason, start of the another anti-lymphoma treatment, SAE preventing continuation of the protocol treatment - Health status measured with EQ-5D from EuroQoL Group - Treatment tolerability assessment — reporting of serious adverse events (SAEs), adverse events (AEs) and adverse events of special interest. ;Timepoint(s) of evaluation of this end point: The final analysis will be performed 3 years and 2 months after the last patient has signed the ICF.

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Countries

Poland

Contacts

Public ContactKlinika Nowotworów Ukladu Chlonnego

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

klinikachloniakow@coi.pl0048225462448

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026