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The FILO CLINICAL TRIALS

FILO investigating centers are involved in numerous clinical trials.
Sponsor of such clinical trials can be pharmaceutical companies, hospital facilities, or cooperative groups or FILO itself.
These clinical trials can be early phase I (where new molecules are tested), trials testing the safety and / or efficacy of a single or combination therapy (Phase I to III) or observational cohorts.

ON GOING CLINICAL TRIALS IN CLL WITH FILO AS A SPONSOR:

  • Frontline:

The only clinical trial open for inclusion promoted by FILO and carried out in collaboration with the Australian ALSG group is:

CLL6-RESIDUUM :

An Australasian and French, Phase III, Multicenter, Randomized Trial Comparing Lenalidomide Consolidation Versus No Consolidation in Patients With Chronic Lymphocytic Leukemia and Residual Disease Following Induction Chemotherapy

Investigators:

Dr. Thérèse Aurran
IPC MARSEILLE, PARIS
e-mail: aurrant@ipc.unicancer.fr

Pr. Florence Cymbalista
Hôpital Avicenne, BobignyFRANCE
e-mail: florence.cymbalista@avc.aphp.fr

  • Relapse:

No clinical trial for patients in relapse for CLL for the moment.

ONGOING CLINICAL TRIALS IN WALDENSTROM DISEASE WITH FILO AS A SPONSOR:

  • Frontline

ECWM1 :

Efficacy of first line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for patients with Waldenström's Macroglobulinemia

Investigators:

Pr. Véronique Leblond
Groupe Hospitalier Pitié Salpêtrière, PARIS, FRANCE
e-mail: veronique.leblond@aphp.fr

Dr. Pierre Morel
CH LENS / CHU AMIENS, FRANCE
e-mail: morel.pierre@chu-amiens.fr

  • Relapse

REMODEL WM3:

An Open Label Non-Randomized Phase II Study Exploring "chemo-free" treatment association with Idelalisib + Obinutuzumab in Patient with relapsed / refractory Waldenstrom's Macroglobulinemia (MW)

Investigators:

Dr. Cécile Tomowiak
CHU POITIERS, FRANCE
e-mail: cecile.tomowiak@chu-poitiers.fr

Pr. Véronique Leblond
Groupe Hospitalier Pitié Salpêtrière, Paris, FRANCE
e-mail: veronique.leblond@aphp.fr

COMPLETED CLINICAL TRIALS IN CLL AND IN WM:

Here are the closed trials designed by the CLL/WMCLL-MW Intergroup (GCFLLC / MW alone or in association with GOELAMS: Groupe Ouest-Est des Leucémies et Maladies du Sang) (prior to merge of these cooperative groups as FILO).
The first three randomized controlled trials completed included more than 3 500 patients. These trials have resulted in numerous publications in particular in Blood, Lancet and the New England Journal of Medicine.

The "LLC 80" trial included 612 stage A patients, 289 stage B and 72 stage C.
The "LLC 85" trial enrolled 1 400 patients including 926 stage A patients.
The "LLC 90" trial involved 938 stage B and C patients.

More recently the following trials have been carried out and have led for some of them to publication in international journals.

In CLL:

The "CLL01-65 / 70" trial for elderly subjects (65 to 70 years old) tested the interest of a consolidation by Campath.
2002 PHRC
Principal Investigator: Pr Alain Delmer, FRANCE
Sponsor : GCFLLC / MW


The "AUTO LLC" trial for young subjects (<65 years old) tested the hypothesis of an early intensification by autograft in stages B and C CLL patients.
2001 PHRC
Principal Investigator: Dr. Laurent Sutton, FRANCE
Sponsor: SFGM


The "CLL2007 FMP" trial tested FCR versus FCMabCampath with 178 stages B and C patients included.
Principal Investigators: Dr. Stéphane Lepretre, FRANCE/ Pr. Pierre Feugier, FRANCE
Sponsor: GCFLLC / MW / GOELAMS


The "CLL7" trial of the stage A CLL patients, together with the German group tested the interest of an early treatment in 75 poor prognosis stage A patients.

Principal Investigators: Pr. Florence Cymbalista, FRANCE / Dr. Vincent Lévy, FRANCE
Sponsor: GCFLLC / MW


The "CLL2007 SA" trial compared the efficacy of Rituximab maintenance in 409 first line CLL randomized patients over 65 years of age.
2005 PHRC
Principal Investigators: Dr. Caroline Dartigeas FRANCE / Dr. Eric Van Den Neste BELGIUM
Sponsor: GCFLLC / MW / GOELAMS


The "ICLL-03 RICAC PMM" trial evaluating residual disease by preemptive immunointervention after allogeneic haematopoietic stem cells transplantation in CLL patients with graft indication has just completed its recruitment.
Investigators: Pr. Olivier Tournilhac FRANCE / Dr. Nathalie Dhedin FRANCE
Sponsor: GCFLLC / MW / GOELAMS


The "CLL2010 FMP" trial tested a Rituximab prephase followed by 6 FCR cures versus 6 FCR cures without prephase and included 140 evolutive stages A, B or C patients.
Principal Investigators: Pr. Guillaume Cartron FRANCE / Dr. Stéphane Lepretre FRANCE
Sponsor : FILO


The "ICLL-07 GAI" trial tested a "chemo-free" treatment in order to spare chemotherapy.
It included a first part combining a monoclonal antibody, GA101, with Ibrutinib therefore without chemotherapy, then treatment sequence guided by response to this first part integrating the results of blood and marrow minimal residual disease (MRD). It has included 135 evolutive stages A, B or C patients.
Principal Investigators: Dr. Anne-Sophie Michallet FRANCE / Pr. Pierre Feugier FRANCE
Sponsor : FILO


The "ICLL01-BOMP" trial tested a rescue treatment with Bendamustine, Ofatumumab and Methylprednisolone for relapsed patients and has included XXX patients.
Principal Investigators: Pr. Olivier Tournilhac FRANCE / Dr. Sophie De Guibert FRANCE
Sponsor: FILO

In Waldenström’s macroglobulinemia:

"WM1" trial : "Randomized trial comparing chlorambucil and fludarabine in Waldenstrom disease and lympho-plasmocytic / immunocytoma lymphomas".
Principal Investigator: Pr. Véronique Leblond
Sponsor: Intergroup LLC-MW
"WM2" trial : "Phase IIA therapeutic trial evaluating the efficacy of Bortezomib (Velcade) in patients with advanced Waldenstrom disease".
Principal Investigator: Pr. Véronique Leblond​

 

CLINICAL TRIALS UNDERWAY IN AML WITH FILO AS A SPONSOR :

BIG-1 study :

Sponsor in collaboration with the ALFA Group and the French Society of Graft end Cellular Therapy (SFGMTC).

Title: Phase 3 trial to improve the overall survival of AML in adults aged 18 to 60 by comparing high-dose idarubicin with daunorubicin at induction, high-dose and intermediate-dose cytarabine in consolidation and mycophenolic acid to standard prophylaxis in the prevention of graft-versus-host disease in allografted patients in first complete remission: Inter-Group-1 Backbone Trial (BIG-1)
 

Investigators :

Pr. Mathilde HUNAULT

MaHunault@chu-angers.fr

CHU ANGERS

 

Pr. Hervé DOMBRET

herve.dombret@aphp.fr

Hôpital Saint Louis

Sponsor : University Hospital of Angers

Opened since 2015

 

LAM-SA 2013 Observatory :

Title: Epidemiological study of a prospective cohort of patients aged 60 years and older treated for AML and receiving intensive induction therapy.

Investigators :

Pr. Arnaud PIGNEUX

arnaud.pigneux@chu-bordeaux.fr

CHU BORDEAUX

The register is open since January 2015.

 

EPAG :

Title : A phase II Study, randomized, placebo-controlled, study to assess the efficacity of Eltrombopag (thrombopoietin receptor agonist) administered to elderly patients with AML receiving induction chemotherapy.

Investigators :

Pr. Arnaud PIGNEUX

arnaud.pigneux@chu-bordeaux.fr

CHU BORDEAUX

 

Dr. Pierre-Yves DUMAS

pierre-yves.dumas@chu-bordeaux.fr

CHU BORDEAUX

 

CLINICAL TRIALS COMPLETED IN AML WITH FILO AS A SPONSOR :

LAM-SA 2007 (sponsor ex GOELAMS):

Title : An open randomized multicenter trial evaluating the contribution of CCNU (Lomustine) at induction and consolidation in the treatment of acute myeloid leukemia (AML) in patients over 60 years old.
 

Investigator :

Pr. Arnaud PIGNEUX

arnaud.pigneux@chu-bordeaux.fr

CHU BORDEAUX

 

This study has been presented as a poster at ASH 2015 (Orlando) and its infectious complications will appear in a poster at ASH 2017 (Atlanta). It is currently submitted for publication.

 

EFFIKIR-IPH21 02 (sponsor : INNATE PHARMA):

A study in collaboration with ALFA Group. Sponsor drug industry.

Title : Randomized, double-blind phase II study with IPH2102 (KIR inhibitor) versus placebo during maintenance in elderly patients with AML in complete remission.

Investigator :

Pr. Norbert VEY

veyn@ipc.unicancer.fr

IPC Marseille

 

UPCOMING CLINICAL TRIALS IN AML:

LAM-SA 2018 (DEX-AML 02):

Title : A phase II study of dexamethasone added to induction and post-remission therapy in elderly patients with newly diagnosed AML. A French Innovative Leukemia Organization (FILO) study.

 

Investigators :

Pr. Christian RECHER

christian.recher@iuct-oncopole.fr

IUCT Oncopole TOULOUSE

 

Dr. Sarah BERTOLI

bertoli.sarah@iuct-oncopole.fr

IUCT Oncopole TOULOUSE

 

Phase III Study with CPX-351 :  

A study in collaboration with ALFA Group. Sponsor : FILO and ALFA Groups.

Title : A Phase III multicenter randomized study of CPX-351 (cytarabine:daunorubicin liposomal formulation) versus conventional care regimen (CCRs) for the treatment of patients aged 60 to 80 years with high-risk acute myeloid leukemia (AML) considered as fit to receive intensive therapy.

 

Investigators :

Pr. Hervé DOMBRET

herve.dombret@aphp.fr

Hôpital Saint Louis, Paris

 

Pr. Christian RECHER

IUCT Oncopole TOULOUSE

christian.recher@iuct-oncopole.fr