NCT00842595

Brief Summary

The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

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 Dec 2003

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

December 1, 2003

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2010

Enrollment Period

5.9 years

First QC Date

February 11, 2009

Last Update Submit

July 23, 2013

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

relapsed aggressive B-cell lymphomaChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate

    CR AFTER 3 R NIMP COURSES

Secondary Outcomes (3)

  • overall remission rate

    OS after 3 R NIMP COURSES

  • Toxicity

    R NIMP TOLERANCE

  • Pharmacoeconomy

    treatment phramacoeconomy

Study Arms (1)

R NIMP

EXPERIMENTAL

(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5

Drug: rituximabDrug: vinorelbineDrug: ifosfamideDrug: MitoxantroneDrug: Prednisone

Interventions

rituximabDRUG

6 courses every 28 days

Also known as: (Mabthera ® )Rituximab IV 375 mg/m²day
R NIMP
vinorelbineDRUG

6 courses every 28 days

Also known as: (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5
R NIMP
ifosfamideDRUG

6 courses every 28 days

Also known as: (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5
R NIMP
MitoxantroneDRUG

6 courses every 28 days

Also known as: (Novantrone®) Mitoxantrone 10mg/m² day1
R NIMP
PrednisoneDRUG

6 courses every 28 days

Also known as: (Cortancyl®)Prednisone 1m/kg day 1 to day 5
R NIMP

Eligibility Criteria

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

You may qualify if:

  • Both genders, between 18 and 75 years old
  • CD 20+ large cell lymphoma
  • In first relapse
  • No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
  • Ann Arbor stage I, II, III ou IV
  • ECOG 0,1 or 2
  • Signed informed consent

You may not qualify if:

  • age: before 18 and more than 75 years old
  • other type of lymphoma
  • Informed consent not signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital COCHIN

Paris, 75014, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

RituximabVinorelbineIfosfamideMitoxantronePrednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicQuinonesPolycyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Emmanuel GYAN

    French Innovative Leukemia Organisation

    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 11, 2009

First Posted

February 12, 2009

Study Start

December 1, 2003

Primary Completion

November 1, 2009

Study Completion

May 1, 2010

Last Updated

July 24, 2013

Record last verified: 2010-07

Locations

FR(1)