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Follicular LymphomaPhase 3PLRG4NCT00801281

First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.

A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Polish Lymphoma Research Group at 12 sites in Poland.

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

Evaluation of event free survival (EFS) of patients treated with the study chemotherapy induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rituximab, Cyclophosphamide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
12 sitesPoland
Study dates
Feb 2007to 25 Jun 2017
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed:
  • Follicular lymphoma grade 1, 2, 3a
  • Marginal zone lymphoma, including MALT type
  • Small lymphocytic lymphoma (BM inv. < 30%)
  • Lymphoplasmacytic lymphoma
  • Clinical stage II-IV (Ann Arbor). Stage I is allowed if bulky (Ø > 7 cm) or if radiotherapy is not appropriate in judgment of treating physician
Show all 15Show fewer
  • Measurable lesion(s) in at least one site
  • Patients previously untreated
  • Patients presenting with symptoms requiring treatment:
  • Progressive disease
  • Symptoms related to tumor bulk
  • Cytopenias related to bone marrow and/or spleen involvement B symptoms
  • Age ≥ 18 years
  • Performance status </=2
  • Written informed consent

Who cannot join

  • Grade 3b FL
  • Transformed lymphoma
  • CNS involvement
  • Patient taking steroids for > 2 weeks during last 4 weeks at a dose equivalent to ≥ 20 mg prednisone
  • Other malignancy
  • Major surgery within 4 weeks
Show all 12Show fewer
  • Hb < 8 g/dl, ANC < 1.5 x 109/L, Plt <100 109/L unless due to lymphoma
  • Impairment of renal function (creatinine > 1.5 x UNV) or liver function (total bilirubin 1.5 x UNV, SGOT > 2.5 x UNV not due to lymphoma
  • Known infection, with HBV, HCV (acute < 6 mos. or chronic hepatitis) or HIV
  • Serious underlying medical conditions
  • Life expectancy < 6 months
  • Known allergy to murine protein

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Poland12 sites

  • Podkarpacki Oncology Centre

    Brzozów, 36-200

  • Voivodeship Hospital, Oncology Ward

    Elblag, 82-300

  • Academic Clinical Centre, Hospital of Medical Academy, Clinic of Haematology and Transplantology

    Gdansk, 80-211

  • Silesian Medical University, Chair and Clinic of Haematology and Bone Marrow Transplantation

    Katowice, 40-029

  • Collegium Medicum Jagiellonian University, Clinic of Haematology

    Krakow, 31-501

  • Regional Oncology Centre, Ward of Proliferative Diseases

    Lodz, 93-509

  • Oncology Centre of Lublin Region

    Lublin, 20-090

  • Central Clinical Hospital, Ministry of Internal Matters and Administration; Clinic of Oncology, Haematology and Internal Diseases

    Warsaw, 02-507

  • Institute of Haematology and Transfusiology

    Warsaw, 02-776

  • M.Sklodowska-Curie Institute - Oncology Centre

    Warsaw, 02-782

  • Medical Academy in Wrocław; Chair and Clinic of Haematology, Blood Neoplasm and Bone Marrow Transplantation

    Wroclaw, 50-367

  • SP ZOZ Silesian Centre of Cellular Transplantation

    Wroclaw, 53-439

Other trials in Poland

About this study

Official title: First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.

Evaluation of event free survival (EFS) of patients treated with the study chemotherapy induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment.

Read the detailed description

Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.

Being tested
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone 1
Keywords
Lymphoma, Immunochemotherapy, Induction therapy, Maintenance therapy, Follicular lymphoma grade 1,2,3a, Marginal zone lymphoma, including MALT type, Small lymphocytic lymphoma (BM inv. <30%)
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

What participants receive

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

  • RituximabDrug

    Also called MabThera

    Rituximab 375 mg/m2 i.v. d. 1 q. 21 d.

  • CyclophosphamideDrug

    Also called Endoxan, Cytoxan

    Cyclophosphamide 750 mg/m2 i.v. d. 1 q. 21 d.

  • DoxorubicinDrug

    Also called Adriamycin

    Doxorubicin 50 mg/m2 i.v. d. 1 q. 21 d.

  • VincristineDrug

    Also called Oncovin

    Vincristine 1.4 mg/m2 (max. 2 mg) i.v. d. 1 q. 21 d.

  • Prednisone 1Drug

    Also called Deltasone

    Prednisone 100 mg p.o. d. 1-5 q. 21 d.

  • Prednisone 2Drug

    Also called Deltasone

    Prednisone 40 mg/m2 p.o. d. 1-5 q. 21 d.

Study groups in NCT00801281
Study groupRoleWhat they receive
R-CVPActive comparatorStandard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone 2
R-CHOPExperimentalStudy arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone 1

What is being measured

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

  1. Event Free Survival

    Measured: +3 yrs

Secondary outcomes (1)

  1. Response Rate

    Measured: +2 yrs

Timeline

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

  1. First posted3 Dec 2008 (estimated)
  2. Study startFeb 2007
  3. Primary completion25 Jun 2017
  4. Study completion25 Jun 2017

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801281
Sponsor's protocol ID
R-CVP/CHOP
Acronym
PLRG4
Status last verified
Jul 2017
First submitted
2 Dec 2008
Last updated
17 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Polish Lymphoma Research Group at 12 sites in Poland.

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 15 inclusion and 12 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 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Event Free Survival (time frame: +3 yrs). 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 NCT00801281.

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 17 Jul 2017.

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