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Diffuse Large B-cells Non-Hodgkin LymphomaPhase 2NCT02955823

A Phase II Study of the FIL on Elderly Frail Patients With DLBCL

A Phase 2 study testing Rituximab-Dexamethasone-Lenalidomide in people with Diffuse Large B-cells Non-Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 18 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

A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma. Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Rituximab-Dexamethasone-Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
18 sitesItaly
Study dates
Sep 2016to 24 Nov 2022
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically proven CD20 positive Diffuse Large B-cell Lymphoma according to WHO classification (local pathologist)
  • Age ≥ 70 years
  • Previously untreated
  • CGA assessment performed before starting treatment
  • FRAIL patients defined as follows
  • Age > 80 years (with UNFIT profile):
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  • ADL ≥ 5 residual functions and/or IADL ≥ 6 residual functions and/or CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2
  • Age < 80 (ONLY one of the following criteria):
  • ADL ≤ 4 residual functions IADL ≤ 5 residual functions CIRS: 1 comorbidity of grade 3-4 or > 8 comorbidities of grade 2
  • Ann Arbor Stage I - IV (Appendix F)
  • At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan
  • ECOG performance status of 0- 3 (Appendix E)
  • No active hepatitis C virus (HCV) infection. In case of HCV positivity HCV-RNA is required. Only patients with HCV-RNA negative are accepted.
  • Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:
  • Hemoglobin > 10 g/dL
  • WBC > 2500/mmc with PMN > 1000/ mmc
  • Platelets count ≥ 75000/mmc
  • Creatinine clearance ≥ 10 mL/min
  • Ability and willingness to comply with the study protocol procedure
  • Life expectancy > 6 months
  • Patients must give written informed consent.
  • Male subjects must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy.

Who cannot join

  • Histological diagnosis different from CD20 positive Diffuse Large B-cell Lymphoma are excluded.
  • Previous exposure to cytotoxic agents
  • Suspect or clinical evidence of CNS involvement by lymphoma
  • Contraindication to the use of Rituximab or of Lenalidomide
  • HBsAg positivity; HBsAg-negative patients with anti-HBc antibody can be enrolled if Hepatitis B Virus (HBV)-DNA are negative and antiviral treatment with Lamivudine or Tenofir is provided.
  • HIV positivity
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  • Active herpes zoster infection; previously infected patients is accepted only with concomitant treatment with Valacyclovir.
  • Any history of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • AST /ALT > 2 x UNL; bilirubin > 2 x UNL; serum creatinine > 2.5 mg /dL
  • Creatinine clearance < 10 mL/min
  • Evidence of any severe active acute or chronic infection
  • Severe cardiac dysfunction (NYHA grade III-IV)
  • Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  • Absence of caregivers in non-autonomous patients

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Italy18 sites

  • Clinica di Ematologia A.O.Universitaria Ospedali Riuniti, Ancona

    Ancona

  • A.O. Spedali Civili di Brescia - Ematologia

    Brescia

  • IRCCS AOU S. Martino - IST - Clinica Ematologica

    Genova

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia

    Meldola, Forlì-Cesena

  • Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia

    Messina

  • Ospedale Dell'Angelo - U.O. Ematologia

    Mestre, Venezia

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

  • Azienda Ospedaliero - Universitaria Policlinico di Modena - Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica

    Modena

  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova

  • AOU di Parma - U.O. Complessa di Ematologia

    Parma

  • Ospedale Guglielmo da Saliceto - U.O.Ematologia

    Piacenza, 29121

  • Ospedale delle Croci - Ematologia

    Ravenna

  • Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS - Ematologia

    Reggio Emilia, Reggio Emilia

  • Ospedale degli Infermi di Rimini - U.O. di Ematologia

    Rimini

  • Policlinico Universitario Campus Bio-Medico - Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare

    Roma

  • Univ. Perugia Sede Terni - Oncoematologia

    Terni

  • A.O. C. Panico - U.O.C Ematologia e Trapianto

    Tricase, Lecce

  • Ospedale ULSS 6 di Vicenza - Ematologia

    Vicenza

Other trials in Italy

About this study

Official title: A Combination of Lenalidomide and Rituximab as Front Line Therapy for the Treatment of Elderly Frail Patients Evaluated in CGA With Diffuse Large B-cells Non-Hodgkin Lymphoma. A Phase II Study of the Fondazione Italiana Linfomi (FIL)

A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.

Read the detailed description

This is a prospective, multicenter, single arm, phase II trial in elderly patients (≥ 70 years) affected by DLBCL defined as frail according to CGA and previously untreated.

The primary endpoint is to evaluate the efficacy of the R2 (Revlimid+Rituximab) combination in first line DLBCL patients not candidate for the standard R-CHOP (or R-CHOP like) treatments due to the frail status.

Being tested
Rituximab-Dexamethasone-Lenalidomide
Keywords
B cell Lymphoma, non-Hodgkin Lymphoma, Elderly patients
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • Rituximab-Dexamethasone-LenalidomideDrug

    1. st CYCLE: Rituximab 375 mg/m2 i.v. on days 1,8,15; Dexamethasone 5 mg p.o. on days 1,8,15,22; Lenalidomide 15 mg/day p.o. day 2-22
    2. nd-4th CYCLE: Rituximab 375 mg/m2 i.v. on day 1; Lenalidomide 20 mg/day p.o. from day 2 to day 22 At the end of 4th CYCLE disease restaging: - if ≥ PR continues with the 5th and 6th cycle: Rituximab 375 mg/m2 i.v. on day 1, Lenalidomide 20 mg /day p.o. day 2-22
    • if <PR stops the treatment, only follow-up At the end of the 6th CYCLE disease restaging: - if ≥ PR continues with beyond the 6th cycle with Lenalidomide 10mg dd1-21q28 until cycle 12th
    • if <PR stops the treatment, only follow-up Then, accordingly response rate after the sixth cycle assessment(≥ PR) lenalidomide will be continued at 10 mg dd1-21q28 until 12th cycle or unacceptable toxicity.
Study groups in NCT02955823
Study groupRoleWhat they receive
1 arm for all patient: Ritux-Dexame-LenaExperimentalRituximab-Dexamethasone-Lenalidomide
Receives: Drug: Rituximab-Dexamethasone-Lenalidomide

What is being measured

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

  1. ORR

    Overall response rate (ORR) is defined as the proportion of patients with complete and partial response respectively according to Cheson 2014 (Appendix K).

    The ORR rate will be evaluated both on assessed patients and on all treated patients, considering patients without a response assessment (due to any reason) as non-responders.

    Response of R2 will be calculated for the EP according to Response Criteria for non-Hodgkin lymphoma (NHL) with CT scan; Cheson 2014; patients will be categorized into Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Non Responders (NR).

    Measured: 48 months

  2. Safety: clinical relevant toxicity

    Clinical relevant toxicity, defined as the proportion of patients experiencing a grade 3 or greater non haematological toxicity.

    Measured: 48 months

Secondary outcomes (5)

  1. CR

    1. Complete response rate (CR) according to Response Criteria for non-Hodgkin lymphoma (NHL) with CT scan; Cheson 2014.

    Measured: 48 months

  2. OS

    1. Overall Survival (OS) will be defined as the time between the date of enrolment and the date of death from any cause. Patients who have not died at the time of the final analysis and patients who are lost to follow up will be censored at the date of the last contact.

    Measured: 54 months

  3. PFS

    1. Progression Free Survival (PFS) will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause. Responding patients, patients who are lost to follow up, who withdrawal the consent or drop-out due to adverse event will be censored at their last assessment date. Patients died due to tumor will be considered in progression. Patients died for any other cause will be censored to the death date.

    Time to event data (PFS, OS) will be estimated using the Kaplan-Meier method. The curves will be plotted and the 95% confidence interval for median time will be calculated.

    Measured: 54 months

  4. EFS

    1. Event-Free Survival (EFS), (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death). Responding patients, patients who are lost to follow up, who withdrawal the consent or drop-out due to adverse event will be censored at their last assessment date. Patients died due to tumor will be considered in progression. Patients died for any other cause will be censored to the death date.

    Measured: 54 months

  5. Quality of life

    1. Patients will assess their health-related quality of life (HRQoL) using two validated questionnaires: the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) and the Quality of life (EORTC-QLQ-C30). Items for inclusion in the lymphoma subscale were selected on the basis of symptom relevance, disease specificity, and clinical relevance.

    Measured: 54 months

Timeline

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

  1. First posted4 Nov 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion22 Sep 2020
  4. Study completion24 Nov 2022

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955823
Sponsor's protocol ID
FIL_ReRi
Status last verified
Dec 2022
First submitted
2 Nov 2016
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gini G, Tani M, Tucci A, Marcheselli L, Cesaretti M, Bellei M, Pascarella A, Ballerini F, Petrini M, Merli F, Olivieri A, Lanza F, Annibali O, Zilioli VR, Liberati AM, Tisi MC, Arcari A, Marino D, Musuraca G, Pavone V, Fabbri A, Pozzi S, Mannina D, Plenteda C, Celli M, Luminari S. Lenalidomide plus rituximab for the initial treatment of frail older patients with DLBCL: the FIL_ReRi phase 2 study. Blood. 2023 Oct 26;142(17):1438-1447. doi: 10.1182/blood.2022019173.

    PubMed 37418685

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab-Dexamethasone-Lenalidomide in people with Diffuse Large B-cells Non-Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 18 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 22 inclusion and 14 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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

ORR (time frame: 48 months). The study lists 2 primary outcomes in all. 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 NCT02955823, 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 23 Dec 2022.

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