Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse After First Line Immunochemotherapy With Autologous Stem Cell (OPERAPLRG-10)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03229382
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Polish Lymphoma Research Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma Drug: Obinutuzumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse After First Line Immunochemotherapy With Autologous Stem Cell (ML29157).
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Obinutuzumab 1000 mg IV infusion, day: 1, 8, 15, 22 Drug: Obinutuzumab
Patients, in whom all inclusion criteria have been confirmed and all exclusion criteria have been ruled out, will receive 4 intravenous infusions of obinutuzumab (GA101, Gazyvaro) at a dose of 1000 mg on Days 1, 8, 15 and 22.
Other Names:
  • Gazyvaro
  • GA101




Primary Outcome Measures :
  1. MRD negativity defined as a MRD level [ Time Frame: 2 months after obinutuzumab treatment ]
    Molecular response rate (molRR) defined as a rate of molecular response with at least 10-4 sensitivity level assessed by quantitative RQ-PCR


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 3 years and 2 month ]
    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

  2. Time to molecular relapse [ Time Frame: 3 years and 2 month ]
    as the time from the date of the first obinutuzumab infusion to the first occurrence of molecular disease relapse

  3. Overall survival (OS) [ Time Frame: 3 years and 2 month ]
    defined as the time from the date of the initiation of the first line treatment to the death from any reason

  4. Time to relapse/progression [ Time Frame: 3 years and 2 month ]
    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

  5. Event-free survival (EFS) [ Time Frame: 3 years and 2 month ]
    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

  6. Health status measured with EQ-5D from EuroQoL Group [ Time Frame: 3 years and 2 month ]
    with EQ-5D from EuroQoL Group

  7. Treatment tolerability assessment [ Time Frame: 3 years and 2 month ]
    reporting of serious adverse events (SAEs), adverse events (AEs) and adverse events of special interest



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 in CR/PR 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 < 1% per year) while receiving the study medication and for 18 months after its discontinuation,
  • Men must consent either to using an acceptable contraception method (that results in a failure rate of < 1% per year) or continued sexual abstinence while receiving the study medication and for 6 months after its discontinuation.

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 authorisation) 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/h),
  • Hepatic impairment (total bilirubin concentration > 1.5 × upper limit of normal, AST and ALT > 2.5 × upper limit of normal),
  • Hb< 9 g/dl, ANC < 1.5 G/l, platelets < 75 G/l,
  • International normalized ratio (INR) > 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.

Information from the National Library of Medicine

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): NCT03229382


Contacts
Layout table for location contacts
Contact: Michał Szymczyk, MD +48 22-546-2448 michal.szymczyk@coi.pl

Locations
Layout table for location information
Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej- Curie Klinika Nowotworów Układu Chłonnego Recruiting
Warszawa, Poland, 02-781
Contact: Michał Szymczyk, MD    +48 22-546-3248    michal.szymczyk@coi.pl   
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytetu Medycznego Not yet recruiting
Wrocław, Poland, 50-369
Contact: Tomasz Wróbel, MD, PhD, Prof    +48 71-784-2576    tomasz.wrobel@umed.wroc.pl   
Sponsors and Collaborators
Polish Lymphoma Research Group
Roche Pharma AG

Layout table for additonal information
Responsible Party: Polish Lymphoma Research Group
ClinicalTrials.gov Identifier: NCT03229382     History of Changes
Other Study ID Numbers: ML29157
2015-005439-41 ( EudraCT Number )
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Polish Lymphoma Research Group:
MCL, obinutuzumab

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents