NCT00842114

Brief Summary

Rituximab plus CVP and Interferon chemoimmunotherapy for newly diagnosed Follicular Lymphoma with FLIPI index \>2

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

10.1 years

First QC Date

February 10, 2009

Last Update Submit

March 31, 2016

Conditions

Non-Hodgkin's Lymphoma

Keywords

Intermediate-high FLIPI scoreFollicular LymphomaProgression free survival

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS) with the CVP + IFNalfa + Rituximab treatment

    August 2012

Secondary Outcomes (1)

  • Overall response (ORR) and complete response (CR) rates. Overall Survival MRD by RT-PCR assay Toxicity

    August 2012

Study Arms (1)

R+CVP+IFN

EXPERIMENTAL

8 cycles of Rituximab plus CVP chemotherapy (Bagley's et al) associated with Interferon for 12 weeks

Biological: R+CVP+IFN

Interventions

R+CVP+IFNBIOLOGICAL

Immunochemotherapy

Also known as: Mabthera -Rituximab (375 mg/sm, D1)/cycle, Cyclophosphamide (400 mg/sm, D 1-5)/cycle, Prednisone (100 mg/sm,D 1-5)/cycle, Vincristine (1.4 mg/sm, max 2 mg, D 1)/cycle, Interferon -IFN (3 MU/sm x 3 times/week, x 12 weeks)
R+CVP+IFN

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years-75 years
  • Pathologically confirmed low grade, Follicular B cell lymphoma (WHO Classification Follicular grades 1 and 2) , Marginal zone lymphoma or Lymphocytic lymphoma (excluding CLL and MCL)
  • FLIPI score ≥ 2
  • Chemotherapy-naïve patients. Previous radiation therapy is allowed, but should have been limited.
  • Adequate hepatic (bilirubin or ALT/AST \< 2,5 times UNL) and renal function, except for those directly disease-related
  • Performance status grade 0 to 3
  • Frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
  • Patient information and written informed consent

You may not qualify if:

  • Previous evolutive malignancy within 5 years of study entry
  • Prior chemotherapy treatment
  • Clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
  • Known positivity for HIV, VHB or VHC
  • Pregnant or lactating women. Women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 12 months after cessation of therapy
  • Any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
  • Non controlled thyroid disfunction
  • Severe Autoimmune disease
  • Patients with history of severe neuropsychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Follicular

Interventions

CyclophosphamidePrednisoneVincristineMAX protein, humanInterferons

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Reyes Arranz-Saez, MD

    Fundación Leucemia y Linfoma, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

February 1, 2006

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 4, 2016

Record last verified: 2016-03

Locations

ES(1)