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Diffuse Large B-cell LymphomaPhase 2RV-NHL-PI351NCT00799513

Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma

A Phase 2 study testing Lenalidomide in people with Diffuse Large B-cell Lymphoma, run by IRCCS San Raffaele at 1 site 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

This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients with relapsed or refractory chemosensitive diffuse large B-cell lymphoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteItaly
Study dates
Mar 2009to Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 65 years
  • Age < 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation
  • Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab
  • PR (Partial Response) or CR (Complete Response) to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
  • ECOG (Eastern Cooperative Oncology Group) performance status score < 4
  • Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study
  • Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential

Who cannot join

  • CNS (Central Nervous System) involvement
  • Prior ASCT
  • TTP (Time To Progression) <6 months after first-line therapy
  • Use of experimental drugs during second-line salvage chemotherapy
  • Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus )
  • Active infectious disease
Show all 15Show fewer
  • HIV, HBV (Hepatitis B Virus) or HCV (Hepatitis C Virus) - positivity
  • Impaired liver function (Bilirubin >2 x upper normal limit; ALT (alanine aminotransferase) /AST (aspartate aminotransferase) /GGT (γ-glutamyltransferase) > 3 x upper normal limit) at one month from salvage chemotherapy conclusion
  • Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion
  • Absolute neutrophil count (ANC) <1000/microL
  • Platelet count <75.000 /mm3
  • Hemoglobin <9 g/dL
  • Non-co-operative behaviour or non-compliance
  • Psychiatric diseases or conditions that might impair the ability to give informed consent
  • Pregnant or lactating females

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • San Raffaele Scientific Institute

    Milan, 20132

Other trials in Italy

About this study

Official title: A Phase II Trial to Evaluate the Safety and Activity of Single-agent Lenalidomide Given as Maintenance Therapy After Response to Second-line Therapy in Patients With Relapsed DLBCL, Not Eligible for High-dose Chemotherapy and ASCT (Autologous Stem-Cell Transplantation)

This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients with relapsed or refractory chemosensitive diffuse large B-cell lymphoma

Read the detailed description

Patients older than 65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation with biopsy-proven diffuse large B-cell lymphoma relapsed to previous combination chemotherapy regimen ± rituximab, who achieved at least a partial response to second-line chemotherapy (ICE or DHAP/DHAOx ((D)examethasone (H)igh-dose (A)ra-C - cytarabine (P)latinol (cisplatin)) or MINE (Mesna Ifosfamide Mitoxantrone Etoposide) regimen) + rituximab will receive single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment until progression of disease. Dose reductions of study drug will be made in case of adverse events when reported as correlated and when clinically appropriate.

One-year progression free survival (PFS) will be the primary endpoint and overall survival, response rate and toxicity will be the secondary endpoints. With the null hypothesis (P0) of 1-year PFS of 30%, this study will consider a satisfactory efficacy of lenalidomide worth of further investigation a P1 corresponding to a 1-yr PFS of 50% (that is an absolute increase of 20% in terms of 1-yr progression-free survival). Considering a standard type I error (α) of 0,05 and a power of 80% (Type 2 error of 20%) 47 patients will be necessary for the trial.

Being tested
Lenalidomide
Keywords
Lenalidomide, revlimid, large B-cell lymphoma, relapse
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.

Study groups in NCT00799513
Study groupRoleWhat they receive
LenalidomideExperimentalsingle-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
Receives: Drug: Lenalidomide

What is being measured

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

  1. 1-year Progression-free Survival

    It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored.

    Measured: 1-year

Secondary outcomes (4)

  1. Progression Free Survival

    Secondary measures to describe long term outcome of treatment

    -Progression free survival It is defined as the number of participants, on a 5 yrs follow up, free from disease progression

    Measured: 5 years

  2. Progression

    Progression It is defined as the number of participants with disease recurrence observed on a 5 yrs follow up.

    Measured: 5 years

  3. Duration of Response

    Secondary measures to describe long term outcome of treatment

    • Duration of response It is defined as the number of participants experiencing a PFS (Progression Free Survival) from study therapy longer than previous line of treatment

    Measured: 5 years

  4. Overall Survival

    Secondary measures to describe long term outcome of treatment

    -Overall survival It is defined as the number of participants alive at 5ys from enrolment (death for any cause). Patients alive at last follow-up will be censored.

    Measured: 5 years

Timeline

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

  1. First posted1 Dec 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2017
  4. Study completionAug 2021

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799513
Sponsor's protocol ID
2008-003729-18
Other IDs
2008-003729-18, 2008
Acronym
RV-NHL-PI351
Status last verified
Apr 2024
First submitted
20 Nov 2008
Last updated
10 Apr 2024
Data monitoring committee
Yes

Publications

  • Ferreri AJ, Sassone M, Zaja F, Re A, Spina M, Rocco AD, Fabbri A, Stelitano C, Frezzato M, Rusconi C, Zambello R, Couto S, Ren Y, Arcari A, Bertoldero G, Nonis A, Scarfo L, Calimeri T, Cecchetti C, Chiozzotto M, Govi S, Ponzoni M. Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. Lancet Haematol. 2017 Mar;4(3):e137-e146. doi: 10.1016/S2352-3026(17)30016-9. Epub 2017 Feb 17.

    PubMed 28219694

  • Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9.

    PubMed 23834234

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with Diffuse Large B-cell Lymphoma, run by IRCCS San Raffaele at 1 site 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 7 inclusion and 15 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 10 Apr 2024. 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 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?

Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

1-year Progression-free Survival (time frame: 1-year). 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 NCT00799513, which also lists 2 linked publications.

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 10 Apr 2024.

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RV-NHL-PI351 Clinical Trial NCT00799513 | AzTrials