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Chronic Myeloid LeukemiaPhase 2VeRitAsNCT03455517

Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Venetoclax and Rituximab in people with Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 31 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and patients with a particular characteristic known as 'disrupted TP53' show an inferior outcome after FCR in terms of… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Venetoclax and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
31 sitesItaly
Study dates
31 Oct 2018to 11 May 2023
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 older than18 years and 65 years or less.
  • Diagnosis of CLL meeting the IWCLL 2008 criteria.
  • Total CIRS <6, creatinine clearance >30 ml/min [Cockcroft-Gault]) and ECOG performance status of 0-1.
  • No prior treatment.
  • Umutated IGVH and/or disrupted TP53.
  • Active disease meeting at least 1 of the following the IWCLL 2008 criteria for treatment requirement.
Show all 11Show fewer
  • Adequate bone marrow function without transfusion <2 weeks of screening as follows: absolute neutrophil count (ANC) ≥1.0 x 109/L (growth factors administration is allowed); platelets ≥30 x 109/L. If thrombocytopenia due to BM involvement, platelets should be ≥ 30 x 109/L; hemoglobin value ≥8.0 g/dl.
  • Adequate renal and hepatic function per local reference laboratory reference ranges
  • Female patients of childbearing potential and non-sterile male patients must practice at least one of method of birth control with partner(s) beginning with initial treatment administration and continuing to 12 months after the last dose of Rituximab.
  • Male patients must agree to refrain from sperm donation, from initial treatment administration until 12 months after the last dose of Rituximab.
  • A signed informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.

Who cannot join

  • Any significant concurrent, uncontrolled medical condition or organ system dysfunction and/or laboratory abnormality or psychiatric disease, which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk or prevent the subject from signing the informed consent form.
  • Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia).
  • History of other malignancies Pregnant or lactating females.
  • Inadequate renal function: CrCl <30 mL/min.
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
  • Subject is known to be positive for HIV.
  • Evidence of other clinically significant uncontrolled condition(s)
  • Prior or concomitant fruits and/or specific drugs.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Italy31 sites

  • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

    Alessandria

  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia

    Ascoli Piceno

  • Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia

    Asti

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

    Bari

  • Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

    Bologna

  • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

    Cagliari

  • Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia

    Catanzaro

  • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione

    Cona

  • Aso S. Croce E Carle - Cuneo - Sc Ematologia

    Cuneo

  • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia

    Lecce

  • I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica

    Meldola

  • Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia

    Messina

  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

    Milan

  • Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora

    Milan

  • Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B

    Milan

  • Aou Di Modena - Sc Ematologia

    Modena

  • Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

    Novara

  • Aou Di Padova - Uo Ematologia

    Padova

  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

    Pagàni

  • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo

    Perugia

  • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

    Piacenza

  • Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia

    Ravenna

  • Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia

    Reggio Calabria

  • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

    Reggio Emilia

  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia

    Rimini

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma

  • Università degli Studi di Roma "Sapienza"

    Roma

  • Ao S. Maria - Terni - Sc Onco Ematologia

    Terni

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

    Torino

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

    Torino

  • Ospedale Mauriziano Umberto I - Torino - Scdu Ematologia

    Torino

Other trials in Italy

About this study

Official title: Activity and Safety of Front-linevenetoclax and Rituximab Association (VeRiTAs) in Young and Fit Patients With Chronic Lymphocytic Leukemia (CLL) and Umutated IGVH and/or Disrupted TP53. A Phase 2 Multicenter Study

Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young patients with Chronic Lymphoid Leukemia (CLL). However, patients with a mutation known as IGVH unmutated and patients with a particular characteristic known as 'disrupted TP53' show an inferior outcome after FCR in terms of survival. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses.

Read the detailed description

Fludarabine, cyclophosphamide, and rituximab (FCR) is the gold treatment for fit and young (age ≤65 years) patients with CLL. However, IGVH unmutated patients and patients with disrupted TP53 show an inferior outcome after FCR in terms of PFS and OS. Venetoclax as a single agent or combined with rituximab is an effective treatment for relapsed/refractory patients with IGVH unmutated CLL and/or del(17p) and is associated with a high rate of clinical responses and MRD-negative responses. The achievement of a MRD negative response in CLL is the best treatment endpoint since it is associated with an improved PFS.

In treatment-naive patients with unmutated IGVH and/or disrupted TP53 the venetoclax and rituximab combination could be a more effective regimen than FCR with a 15% increase in the CR rate.

Being tested
Venetoclax, Rituximab
Keywords
Chronic myeloid leukemia, Umutated IGVH, Disrupted TP53
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

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

  • VenetoclaxDrug

    Venetoclax and rituximab association

  • RituximabDrug

    Venetoclax and rituximab association

Study groups in NCT03455517
Study groupRoleWhat they receive
VeritasExperimental* Step 1. All patients: venetoclax 5-weeks dose-titration phase with weekly increases in the dose of venetoclax. * Step 2. All patients will receive 6 courses of the VR combination. * Step 3. After 6 courses of VR combination: 3a. Patients with no response will be off treatment; 3b. Patients with clinical response (CR or PR) after 6 courses of VR combination will receive venetoclax as a single agent for 6 months. Then, patients will be observed clinically until disease progression or until month 36.
Receives: Drug: Venetoclax; Drug: Rituximab

What is being measured

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

  1. Number of patients achieving complete response (CR)

    Measured: At 15 months from treatment start, which is the end of treatment

Secondary outcomes (1)

  1. Number of patients achieving response

    Overall response rate (ORR)

    Measured: At 15 months from treatment start, which is the end of treatment

Timeline

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

  1. First posted6 Mar 2018
  2. Study start31 Oct 2018
  3. Primary completion5 Sep 2021
  4. Study completion11 May 2023

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
Multicenter, prospective, interventional, single arm study
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03455517
Sponsor's protocol ID
LLC1518
Acronym
VeRitAs
Status last verified
Nov 2023
First submitted
28 Feb 2018
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mauro FR, Starza ID, Messina M, Reda G, Trentin L, Coscia M, Sportoletti P, Orsucci L, Arena V, Casaluci GM, Marasca R, Murru R, Laurenti L, Ilariucci F, Stelitano C, Mannina D, Massaia M, Rigolin GM, Scarfo L, Marchetti M, Levato L, Tani M, Arcari A, Musuraca G, Deodato M, Galieni P, Patrizi VB, Gottardi D, Liberati AM, Giordano A, Molinari MC, Pietrasanta D, Mattiello V, Visentin A, Vitale C, Albano F, Neri A, De Novi LA, De Propris MS, Nanni M, Del Giudice I, Guarini A, Fazi P, Vignetti M, Piciocchi A, Cuneo A, Foa R. High rate of durable responses with undetectable minimal residual disease with front-line venetoclax and rituximab in young, fit patients with chronic lymphocytic leukemia and an adverse biological profile: results of the GIMEMA phase II LLC1518 - VERITAS study. Haematologica. 2023 Aug 1;108(8):2091-2100. doi: 10.3324/haematol.2022.282116.

    PubMed 36632738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax and Rituximab in people with Chronic Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 31 sites in Italy.

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 8 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of patients achieving complete response (CR) (time frame: At 15 months from treatment start, which is the end of 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 NCT03455517, which also lists 1 linked publication.

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 24 Nov 2023.

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