AzTrials
AzTrials

Mantle Cell LymphomaPhase 2OPERA-PLRG10NCT03229382

Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse

A Phase 2 study testing Obinutuzumab in people with Mantle Cell Lymphoma, run by Polish Lymphoma Research Group at 1 site in Poland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 sitePoland
Study dates
14 May 2018to 31 Jan 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 11Show fewer
  • 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.

Who cannot join

  • 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,
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Centrum Onkologii - Instytut im. Marii Skłodowskiej- Curie Klinika Nowotworów Układu Chłonnego

    Warsaw, 02-781

Other trials in Poland

About this study

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).

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.

Read the detailed description

Patients with evidence of MCL molecular relapse defined as an increasing copy number in quantitative real-time polymerase chain reaction (RQ-PCR) of clone-specific immunoglobulin heavy chain (IGH) gene rearrangements or BCL1-IGH fusion genes according to BIOMED-2 methodology and protocols in peripheral blood or/and bone marrow without evidence of clinical relapse/progression after auto-HCT procedure with all inclusion and no exclusion clinical trial criteria will receive 4 weekly infusions of obinutuzumab (1000 mg, iv) on day 1, 8, 15, 22.Response assessment in bone marrow and/or peripheral blood and CT/MRI imaging will be performed 2 months after the obinutuzumab preemptive treatment. Patients with subsequent molecular remission in peripheral blood and/or bone marrow confirmed in RQ-PCR (with 10-4 level of sensitivity) assessment and no signs of relapse/progression according to the Lugano Classification will be further followed. From this moment, evaluation of response will be performed every 6 months with computed tomography/magnetic resonance (CT/MR) imaging and bone marrow aspiration to detect classical relapse/progression and/or to detect subsequent molecular relapse by quantitative real-time polymerase chain reaction (RQ-PCR) of clone-specific immunoglobulin heavy chain (IGH) gene rearrangements or BCL1-IGH fusion genes with the use of consensus JH probes and specific ASO primers. Patients will be monitored every 3 months (outpatient visits with peripheral blood samples for MRD assessment to detect molecular relapse by quantitative RQ-PCR of clone-specific immunoglobulin heavy chain (IGH) gene rearrangements or BCL1-IGH fusion genes). Preemptive treatment can be administered in subsequent molecular relapses/progressions.

Being tested
Obinutuzumab
Keywords
MCL, obinutuzumab
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called Gazyvaro, GA101

    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.

Study groups in NCT03229382
Study groupRoleWhat they receive
Obinutuzumab 1000 mg IV infusion, day: 1, 8, 15, 22ExperimentalPatients with evidence of MCL molecular relapse defined as an increasing copy number in quantitative real-time polymerase chain reaction (RQ-PCR) of clone-specific immunoglobulin heavy chain (IGH) gene rearrangements or BCL1-IGH fusion genes according to BIOMED-2 methodology and protocols in peripheral blood or/and bone marrow without evidence of clinical relapse/progression after auto-HCT procedure with all inclusion and no exclusion clinical trial criteria will receive 4 weekly infusions of obinutuzumab.
Receives: Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRD negativity defined as a MRD level

    Molecular response rate (molRR) defined as a rate of molecular response with at least 10-4 sensitivity level assessed by quantitative RQ-PCR

    Measured: 2 months after obinutuzumab treatment

Secondary outcomes (7)

  1. 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

    Measured: 3 years and 2 month

  2. Time to molecular relapse

    as the time from the date of the first obinutuzumab infusion to the first occurrence of molecular disease relapse

    Measured: 3 years and 2 month

  3. Overall survival (OS)

    defined as the time from the date of the initiation of the first line treatment to the death from any reason

    Measured: 3 years and 2 month

  4. 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

    Measured: 3 years and 2 month

  5. 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

    Measured: 3 years and 2 month

  6. Health status measured with EQ-5D from EuroQoL Group

    with EQ-5D from EuroQoL Group

    Measured: 3 years and 2 month

  7. Treatment tolerability assessment

    reporting of serious adverse events (SAEs), adverse events (AEs) and adverse events of special interest

    Measured: 3 years and 2 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2017
  2. Study start14 May 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Why it stopped: Very slow recruitment due to lack of relapse in the observed group of patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03229382
Sponsor's protocol ID
ML29157
Other IDs
2015-005439-41, 2015
Acronym
OPERA-PLRG10
Status last verified
Aug 2023
First submitted
10 Jul 2017
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab in people with Mantle Cell Lymphoma, run by Polish Lymphoma Research Group at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Very slow recruitment due to lack of relapse in the observed group of patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negativity defined as a MRD level (time frame: 2 months after obinutuzumab treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03229382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in