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Non Hodgkin LymphomaPhase 2REAL07NCT00907348

Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of LR-CHOP21 for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma

A Phase 2 study testing LR-CHOP21 in people with Non Hodgkin Lymphoma and Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 18 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective multicenter phase II pilot trial designed with the purpose of dose finding to evaluate the efficacy and safety of treatment with Lenalidomide plus R-CHOP21 (LR-CHOP21) for elderly patients with untreated Diffuse Large B Cell Lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Non Hodgkin Lymphoma, Follicular Lymphoma
What is being tested?
LR-CHOP21
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
18 sitesItaly
Study dates
Oct 2007to Jan 2012
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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign an informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements
  • Histologic subtypes as follows:
  • CD20 positive Diffuse large B-Cell lymphoma
  • CD20 positive Follicular grade IIIb
  • Age 60-80
Show all 26Show fewer
  • Untreated patients. In patients with bulky mass or systemic symptoms or compressive disease or rapidly progressive adenopathies a pre-study treatment is allowed with steroids and/or a single dose of Vincristine 1.4 mg/mq (max 2) in the seven days prior the start of the study treatment
  • Measurable and/or evaluable disease
  • Ann Arbor stage II, III, IV
  • International Prognostic Index at low-intermediate, intermediate-high, high risk (2/3/4-5)
  • Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement
  • Conjugated bilirubin up to 2 x UNL
  • Alkaline phosphatase and transaminases up to 2 x UNL
  • Creatinine clearance > 50 ml/min
  • HIV negativity
  • HCV negativity
  • HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
  • Cardiac ejection fraction (MUGA scan or echocardiography) > 45%
  • Non peripheral neuropathy or CNS disease. Non testicular Lymphoma
  • Life expectancy > 6 months
  • Performance status < 2 according to ECOG scale
  • Comprehensive geriatric assessment (CGA) as outlined in Appendix 15 showing absence of any impairment in activity of daily living (ADL), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to CIRS-G scale
  • Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
  • Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: for at least 28 days before starting study drug;while participating in the study; for at least 28 days after discontinuation from the study
  • The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, cervical cap)
  • FCBP must be referred to a qualified provider of contraceptive methods if needed

Who cannot join

  • Lymphoblastic Lymphoma
  • Burkitt Lymphoma
  • Non Hodgkin lymphoma CD 20 negative
  • Mantle Cell Lymphoma
  • Follicular Non Hodgkin Lymphoma grade I-II-IIIa
  • Primitive mediastinal diffuse large B cell lymphoma with only mediastinal involvement
Show all 25Show fewer
  • International Prognostic Index at low risk (1)
  • Has known or suspected hypersensitivity or intolerance to Rituximab
  • History of evolutive malignancy within the last 3 years other than squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • Extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy before enrollment within 3 years before the start of treatment
  • Exposure to Rituximab prior to study entry
  • Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study
  • CNS disease (meningeal and/or brain involvement by lymphoma) or Testicular involvement
  • DVT in the last year
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  • Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
  • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
  • Creatinine clearance < 50 ml/min
  • Presence of major neurological disorders
  • HIV positivity
  • HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
  • HCV positivity
  • Active opportunistic infection
  • Comprehensive geriatric assessment (CGA) as outlined in Appendix 15 showing presence of any impairment in activity of daily living (ADL), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to CIRS-G scale
  • Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Italy18 sites

  • Divisione di Ematologia Osp. SS. Antonio e Biagio

    Alessandria

  • Divisione di Oncologia Medica A Centro di Riferimento Oncologico

    Aviano

  • Cattedra di Ematologia Università Policlinico

    Bari

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari

  • Istituto di Ematologia "Seragnoli" Polic.S.Orsola-Malpighi

    Bologna, 40138

  • Divisione di Ematologia Spedali Civili

    Brescia

  • Divisione di Ematologia Osp. Businco

    Cagliari

  • Onco-Ematologia I.R.C.C.

    Candiolo (TO)

  • Ematologia 1 Ospedale S. Martino

    Genova, 16132

  • Divisione di Ematologia Ospedale Niguarda

    Milan

  • UO Ematologia II Facoltà di Medicina e Chirurgia Università Federico II

    Naples

  • Divisione di Ematologia Università Avogadro

    Novara

  • UO Ematologia Università - Policlinico San Matteo

    Pavia

  • Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza

    Roma

  • Oncoematologia - Univ. Perugia Sede Terni,

    Terni, 05100

  • S.C.Ematologia 1 AOU San Giovanni Battista

    Torino, 10126

  • SC Ematologia 2 ASO San Giovanni Battista

    Torino

  • UO Ematologia Osp. Cardinale Panico

    Tricase (LE)

Other trials in Italy

About this study

Official title: Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of Treatment With Lenalidomide Plus R-CHOP21 (LR-CHOP21) for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma (DLBCL)

This is a prospective multicenter phase II pilot trial designed with the purpose of dose finding to evaluate the efficacy and safety of treatment with Lenalidomide plus R-CHOP21 (LR-CHOP21) for elderly patients with untreated Diffuse Large B Cell Lymphoma (DLBCL).

Being tested
LR-CHOP21
Keywords
NHL, Non Hodgkin Lymphoma, Follicular Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular

What participants receive

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

  • LR-CHOP21Drug

    FIRST DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 5 mg/day D1-D14

    SECOND DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1;Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 10 mg/day D1-D14

    THIRD DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 15 mg/day D1-D14

    FOURTH DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 20 mg/day D1-D14 Repeated every 21 days

Study groups in NCT00907348
Study groupRoleWhat they receive
Cohorts 1 - 2 - 3 - 4ExperimentalChemiotherapy
Receives: Drug: LR-CHOP21

What is being measured

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

  1. Evaluation of adverse events according with Common Terminology Criteria for Adverse events (CTCAE)

    Measured: 2 years

Secondary outcomes (1)

  1. Overall Response Rate (ORR)

    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 posted22 May 2009 (estimated)
  2. Study startOct 2007
  3. Primary completionOct 2009
  4. Study completionJan 2012 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907348
Sponsor's protocol ID
IIL_REAL07
Acronym
REAL07
Status last verified
Oct 2011
First submitted
21 May 2009
Last updated
13 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • Vitolo U, Chiappella A, Franceschetti S, Carella AM, Baldi I, Inghirami G, Spina M, Pavone V, Ladetto M, Liberati AM, Molinari AL, Zinzani P, Salvi F, Fattori PP, Zaccaria A, Dreyling M, Botto B, Castellino A, Congiu A, Gaudiano M, Zanni M, Ciccone G, Gaidano G, Rossi G; Fondazione Italiana Linfomi. Lenalidomide plus R-CHOP21 in elderly patients with untreated diffuse large B-cell lymphoma: results of the REAL07 open-label, multicentre, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):730-7. doi: 10.1016/S1470-2045(14)70191-3. Epub 2014 May 13.

    PubMed 24831981

  • 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

  • Chiappella A, Tucci A, Castellino A, Pavone V, Baldi I, Carella AM, Orsucci L, Zanni M, Salvi F, Liberati AM, Gaidano G, Bottelli C, Rossini B, Perticone S, De Masi P, Ladetto M, Ciccone G, Palumbo A, Rossi G, Vitolo U; Fondazione Italiana Linfomi. Lenalidomide plus cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab is safe and effective in untreated, elderly patients with diffuse large B-cell lymphoma: a phase I study by the Fondazione Italiana Linfomi. Haematologica. 2013 Nov;98(11):1732-8. doi: 10.3324/haematol.2013.085134. Epub 2013 Jun 28.

    PubMed 23812930

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LR-CHOP21 in people with Non Hodgkin Lymphoma and Follicular 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 26 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 13 Oct 2011. 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?

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?

Evaluation of adverse events according with Common Terminology Criteria for Adverse events (CTCAE) (time frame: 2 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 NCT00907348, which also lists 3 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 13 Oct 2011.

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