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Lymphoma, Mantle-CellPhase 2CLSGMCLPOLANCT04913103

Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL

A Phase 2 study testing Polatuzumab vedotin, Bendamustine Hydrochloride and Rituximab in people with Lymphoma, Mantle-Cell, run by Czech Lymphoma Study Group at 7 sites in Czechia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A Czech Lymphoma Study Group, phase II, open-label, study of polatuzumab-vedotin in combination with bendamustine and rituximab for patients with mantle cell lymphoma, who relapse after previous therapy with Bruton tyrosine kinase inhibitor Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma, Mantle-Cell
What is being tested?
Polatuzumab vedotin, Bendamustine Hydrochloride and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
7 sitesCzechia
Study dates
1 Sep 2021to 31 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written Informed Consent Form
  • Adult patients with relapsed or refractory MCL after failure of BTK inhibitor-containing therapy (e.g. ibrutinib, acalabrutinib, zanubrutinib)
  • Patients previously treated with bendamustine are eligible for the study treatment, in the case they had achieved objective response (CR or PR) and the last dose of bendamustine was administered ≥ 1 year before the estimated study treatment initiation date (C1D1)
  • Tumor tissue at the lymphoma relapse after failure of BTK inhibitor. In case that a re-biopsy is not possible (e.g. urgent need to start study treatment), archival tissue blocks may be used to confirm the diagnosis
  • Bone marrow examination by standard trephine biopsy including flow cytometry analysis within 8 weeks before study entry
  • Age 18-80 years at the time of signing Informed Consent Form
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  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy ≥ 2 months
  • Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by MCL per the investigator), defined as follows:
  • Hemoglobin ≥ 80g/L
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 75,000/μL Enrollment of patients with lower counts is possible only after consulting the medical monitor.
  • Adequate cardiac functions according to echocardiography (ECHO) within 6 months before study entry
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing. Women who are considered not to be of childbearing potential are not required to have a pregnancy test.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
  • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 5 months after the last dose of polatuzumab vedotin, 3 months after the last dose of rituximab, and for at least 6 months after the last dose of bendamustine to avoid exposing the embryo for the duration of the pregnancy. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment.

Who cannot join

  • Prior organ transplantation
  • Current Grade ≥ 2 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
  • History of other malignancy that could affect compliance with the protocol or interpretation of results Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage
  • 1 or 2) with no requirement for therapy at any time prior to study are eligible.
  • Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results.
  • Recent major surgery (e.g. within 4 weeks prior to the start of Cycle 1), other than for diagnosis
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  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1.
  • Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
  • Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
  • INR > 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation aPTT > 1.5 x ULN in the absence of a lupus anticoagulant
  • Serum AST and ALT > 3 x ULN
  • Total bilirubin > 2 x ULN Patients with documented Gilbert disease may be enrolled if total bilirubin is > 3.0 x ULN.
  • Serum creatinine clearance < 40 mL/min (using Cockcroft-Gault formula or creatinine levels assessed directly from the collected urine)
  • Patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
  • Positive test results for chronic hepatitis B infection defined as positive hepatitis B surface antigen (HBsAg) serology
  • Patients with occult or prior hepatitis B infection defined as positive total hepatitis B core antibody and negative HBsAg may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo regular DNA testing and appropriate antiviral therapy as indicated.
  • Positive test results for hepatitis C virus (HCV) antibody serology testing Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Known history of HIV seropositive status
  • Patients with a history of progressive multifocal leukoencephalopathy
  • Pregnancy or lactation or intending to become pregnant during study
  • CNS lymphoma In patients with clinical signs attributable to CNS lymphoma, CT scan (MRI also acceptable) of the head and examination of cerebrospinal fluid will be required prior to study treatment initiation

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pavel Klener, prof.MD,PhD contact

+420224962568

pavel.klener2@vfn.cz

Marketa Petrova, Ing. contact

+420224962676

petrova@lymphoma.cz

7 sites in 1 country

Czechia7 sites

  • University Hospital Brno

    Brno, 625 00

    Andrea Janíková, AssProfMDPhD, +420532 233 642, janikova.andrea@fnbrno.cz

  • University Hospital Hradec Králové

    Hradec Králové, 500 05

    David Belada, Ass.prof.MD, +420 495 832 866, david.belada@fnhk.cz

    Martin Šimkovič, martin.simkovic@fnhk.cz

  • University Hospital Olomouc

    Olomouc, 775 20

    Aleš Obr., MD,Ph.D., +420 588 442 790, ales.obr@fnol.cz

    Vít Procházka, Prof.MD,PhD., vit.prochazka@fnol.cz

  • University Hospital Ostrava

    Ostrava, 70852

    Juraj Ďuraš, MD, +420 597 372 754, juraj.duras@fno.cz

  • University Hospital Plzeň

    Pilsen, 323 00

    Kateřina Steinerová, MD, +420 377 103 722, steinerovak@fnplzen.cz

    Tomáš Procházka, MD, prochazkat@fnplzen.cz

  • University Hospital Kralovske Vinohrady

    Prague, 100 00

    Heidi Mocikova, MD,PhD, +420 267 163 554, heidi.mocikova@fnkv.cz

  • Charles University General Hospital

    Prague, 12800

    Pavel Klener, prof.MD,PhD, +420224962568, pavel.klener2@vfn.cz

    Marek Trněný, prof.MD,CSc., +4202249622527, trneny@cesnet.cz

Other trials in Czechia

About this study

Official title: A Phase II, Open-label Study of Polatuzumab-vedotin (PV) in Combination With Bendamustine and Rituximab for Patients With Mantle Cell Lymphoma, Who Relapse After Previous Therapy With Bruton Tyrosine Kinase Inhibitor

A Czech Lymphoma Study Group, phase II, open-label, study of polatuzumab-vedotin in combination with bendamustine and rituximab for patients with mantle cell lymphoma, who relapse after previous therapy with Bruton tyrosine kinase inhibitor

Read the detailed description

Primary objective:

Efficacy: to evaluate the efficacy of the combination of polatuzumab vedotin plus bendamustine and rituximab (BR) with respect to progression-free survival (PFS)

Secondary objectives:

Efficacy: to evaluate the efficacy of polatuzumab vedotin plus BR with respect to secondary efficacy endpoints, namely overall response rate, duration of response, event free survival and overall survival; Safety objective; Exploratory objectives

Being tested
Polatuzumab vedotin, Bendamustine Hydrochloride, Rituximab
Keywords
refractory/relapsed mantle cell lymphoma, polatuzumab-vedotin, bendamustine, rituximab
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.

  • Polatuzumab vedotinDrug

    Also called Polivy

    treatment by a study drug polatuzumab-vedotin, i.v.

  • Bendamustine HydrochlorideDrug

    Also called Bendamustine Accord, Bendamustine Glenmark, Bendamustine KABI

    treatment by a study drug bendamustin i.v.

  • RituximabDrug

    Also called Mabthera, Rixathon, Truxima

    treatment by a study drug rituximab, i.v.

Study groups in NCT04913103
Study groupRoleWhat they receive
single arm, open-labelExperimentalcombination of polatuzumab-vedotin, bendamustine and rituximab
Receives: Drug: Polatuzumab vedotin; Drug: Bendamustine Hydrochloride; Drug: Rituximab

What is being measured

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

  1. Progression-free survival (PFS)

    evaluation of the efficacy of the combination of polatuzumab vedotin plus bendamustine and rituximab (BR) with respect to progression-free survival (PFS)

    Measured: 4 years

Secondary outcomes (4)

  1. overall response rate (ORR)

    efficacy of polatuzumab vedotin plus BR with respect to overall response rate

    Measured: 4 years

  2. duration of response (DoR)

    efficacy of PV plus BR with respect to duration of response

    Measured: 4 years

  3. event free survival (EFS)

    efficacy of PV plus BR with respect to event free survival

    Measured: 4 years

  4. overall survival (OS)

    efficacy of PV plus BR with respect to overall survival

    Measured: 4 years

Timeline

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

  1. First posted4 Jun 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

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
Model description
open-label, single arm, combination - polatuzumab vedotine + rituximab+bendamustin
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913103
Sponsor's protocol ID
CLSG-MCL-POLA
Acronym
CLSGMCLPOLA
Status last verified
May 2021
First submitted
19 May 2021
Last updated
4 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Polatuzumab vedotin, Bendamustine Hydrochloride and Rituximab in people with Lymphoma, Mantle-Cell, run by Czech Lymphoma Study Group at 7 sites in Czechia.

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 19 inclusion and 22 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: opening soon, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Czechia. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pavel Klener, prof.MD,PhD (+420224962568, pavel.klener2@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 4 years). 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 NCT04913103.

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 4 Jun 2021.

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