NCT00169208

Brief Summary

This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin's lymphoma (NHL).

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 Apr 2001

Longer than P75 for phase_2

Geographic Reach
1 country

16 active sites

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

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

5.7 years

First QC Date

September 9, 2005

Last Update Submit

August 22, 2019

Conditions

Follicular Lymphoma

Keywords

relapsed/refractory.lymphoma, follicularrituximabchemotherapy

Outcome Measures

Primary Outcomes (1)

  • to evaluate progression free survival after a combination of rituximab, fludarabine and mitoxantrone (RFM) in patients with relapsed or primary failing advanced follicular non-Hodgkin's lymphoma.

    2 years

Secondary Outcomes (6)

  • overall response rate (ORR)

    5 years

  • complete response (CR)

    5 years

  • to evaluate overall survival (OS)

    5 years

  • duration of response

    5 years

  • number of Serious Adverse Event (SAE)

    5 years

  • +1 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

4 cycles of rituximab + fludarabine + mitoxantrone

Drug: rituximabDrug: fludarabineDrug: mitoxantrone

Interventions

rituximabDRUG

375 mg/m² IV, D1 each cycle during 4 cycles

Experimental
fludarabineDRUG

40 mg/m²/day IV , D1 each cycle during 4 cycles

Experimental
mitoxantroneDRUG

10 mg/m² IV, D2-3-4 each cycle during 4 cycles

Experimental

Eligibility Criteria

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

You may qualify if:

  • years \< age \< 75 years
  • Pathologically confirmed low grade, follicular, B cell lymphoma (WHO Classification Follicular grades 1 and 2
  • Failed at least first line chemotherapy with any standard anthracycline containing regimen (see appendix C for definition of treatment failure)
  • Frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
  • The lymphoma must be CD20 positive (on the biopsy material obtained at relapse or disease progression)
  • At least one measurable lesion one nodal or extranodal lesion
  • WHO performance status grade 0 or 1
  • Bulky disease at study entry according to the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria: Nodal or extranodal single mass \> 7cm in its greatest diameter; systemic B-symptoms; increased lactate dehydrogenase (LDH) and beta 2 macroglobulinemia (\> 3mg/L); involvement of at least 3 nodal sites, each with a diameter of greater than 3 cm; splenic enlargement with margin below the umbilical line or cranio caudal diameter of greater than 20 cm; compression syndrome (ureteral, orbital, gastrointestinal), or pleural or peritoneal serous effusion.
  • Patient information and written informed consent

You may not qualify if:

  • Evidence of histological transformation to diffuse large B-cell lymphoma
  • \> 2 prior treatment regimen
  • Prior treatment including fludarabine and / or mitoxantrone and / or rituximab or contra-indication to one of these products
  • Unless exempted by the Responsible Investigator, as lymphoma related: serum creatinine \>2 x Institutional Upper Limit of Normal (IULN), total bilirubin \>2 x IULN or aspartate aminotransferase (AST) \>2 x IULN, alkaline phosphatase \>2 x IULN
  • Low bone marrow function: absolute neutrophil count \< 1500/mm3 and platelet \< 100 x 109/L at study entry (unless bone marrow infiltration)
  • Clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
  • Evidence of symptomatic central nervous system disease
  • Known positivity for HIV, hepatitis Bs antigen or hepatitis C
  • Pregnant or lactating women. Women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 6 months after cessation of therapy
  • Patients considered for an autologous or allogenic stem transplant at time of primary treatment failure or relapse according to the rules of the respective centers
  • Any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
  • Previous evolutive malignancy within 5 years of study entry, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
  • Major surgery within 4 weeks prior to enrollment, unless patient has recovered from all treatment related toxicity
  • Patient under tutelage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Service de médecine D - Maladies du Sang CHU Angers

Angers, 49033, France

Location

Service d'Hématologie Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital A. Michallon BP 217X

Grenoble, 38043, France

Location

Service Oncologie - Centre Victor Hugo

Le Mans, 72015, France

Location

Service d'hématologie clinique - Centre Hospitalier du Dr Schaffner

Lens, 62307, France

Location

Hôpital Claude Huriez - Sce des Maladies du Sang - Place Verdun

Lille, 59037, France

Location

Centre Hospitalier Lyon-sud

Lyon, 69310, France

Location

Centre régional de lutte contre le cancer Léon Bérard

Lyon, 69373, France

Location

Service d'hématologie Institut Paoli Calmette

Marseille, 13273, France

Location

Service d'hématologie - Hôpital Necker

Paris, 75015, France

Location

Service d'Hématologie Hôpital St Louis

Paris, 75475, France

Location

Service d'hématologie clinique - Hôpital de Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Service Oncologie CHU Bretonneau

Tours, 37044, France

Location

Service d'hématologie Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (4)

  • Horning SJ. Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol. 1993 Oct;20(5 Suppl 5):75-88. No abstract available.

    PMID: 8211209BACKGROUND

  • McLaughlin P, Hagemeister FB, Romaguera JE, Sarris AH, Pate O, Younes A, Swan F, Keating M, Cabanillas F. Fludarabine, mitoxantrone, and dexamethasone: an effective new regimen for indolent lymphoma. J Clin Oncol. 1996 Apr;14(4):1262-8. doi: 10.1200/JCO.1996.14.4.1262.

    PMID: 8648382BACKGROUND

  • Maloney DG, Grillo-Lopez AJ, White CA, Bodkin D, Schilder RJ, Neidhart JA, Janakiraman N, Foon KA, Liles TM, Dallaire BK, Wey K, Royston I, Davis T, Levy R. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood. 1997 Sep 15;90(6):2188-95.

    PMID: 9310469BACKGROUND

  • McLaughlin P, Grillo-Lopez AJ, Maloney DG, Link BK, Levy R, Czuczman MS, Cabanillas F, Dallaire BK, White CA: Efficacy controls and long-term follow-up of patients treated with rituximab for relapsed or refractory, low-grade or follicular NHL. Blood 92:414a, 1998

    RESULT

Related Links

MeSH Terms

Conditions

Lymphoma, FollicularRecurrence

Interventions

RituximabfludarabineMitoxantrone

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Franck Morschhauser, MD

    Lymphoma Study Association

    PRINCIPAL INVESTIGATOR

  • Charles FOUSSARD, MD

    French Innovative Leukemia Organisation

    STUDY CHAIR

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

September 9, 2005

First Posted

September 15, 2005

Study Start

April 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

FR(16)