Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

November 26, 2013

Primary Completion Date

February 5, 2024

Study Completion Date

October 7, 2024

Conditions
Large Granular Lymphocytes Leukemia
Interventions
DRUG

Methotrexate

methotrexate 10mg / m² orally once a week, (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take, during 4 months.

DRUG

Cyclophosphamide

cyclophosphamide 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take, during 4 months.

Trial Locations (59)

13005

Hematology Unit CHU La Conception, Marseille

13009

Hematology Unit - Institut Paoli-Calmettes, Marseille

14000

Institut d'Hématologie de Basse Normandie, Caen

14076

Hematology Service - CH François Baclesse, Caen

21000

CH Saint Quentin Oncohematology, Saint-Quentin

22027

CH Yves Lefoll, Saint-Brieuc

25030

Hematology Service - CH Jean Minjoz, Besançon

28018

hematology Service - CH Louis Pasteur, Chartres

29609

Hematology Service - CH de Brest, Brest

30029

hematology Unit CHU Caremeau, Nîmes

31000

Hematology Unit CHU Toulouse, Toulouse

33500

CH Robert Boulin, Libourne

33604

Hematology Service- CH Haut Leveque, Pessac

34295

Hematogy Unit CHU ST ELOI, Montpellier

34500

Hematology Service - CH Beziers, Béziers

35000

Hematology Service - CHU of Rennes, Rennes

37044

Hematology Unit CHU Bretonneau, Tours

38043

Hematology Unit CH Michalon, Grenoble

45067

Hematology Unit - CHR Orleans, Orléans

49033

CHU Angers, Angers

49300

Centre Hospitalier de Cholet, Cholet

51092

Hematology Unit- Hopital Robert Debré, Reims

54511

Hematology Unit Hopitaux de Brabois, Vandœuvre-lès-Nancy

56017

Intern Medecine Unit CHBA, Vannes

56322

CH de Bretagne Sud, Lorient

57000

Hematology Unit CH Notre Dame Bon Secours, Metz

59037

Hematology Unit CHRU Lille, Lille

60008

Oncology Unit - Institut de cancérologie de la Loire, Saint-Priest-en-Jarez

60021

hematology service - CH Beauvais, Beauvais

62321

Hematology Service - CH Docteur Duchenne, Boulogne-sur-Mer

63003

hematology Service - CHU Estaing, Clermont-Ferrand

66000

Hematology Unit Hopital Saint Jean, Perpignan

68024

Hematology Service - Civils hospital, Colmar

68070

Hematology Unit CH E.MULLER, Mulhouse

69310

Hematology Unit CH LYON SUD, Pierre-Bénite

72000

Hematology Unit CH LE MANS, Le Mans

74374

CH Annecy - Hematology Service, Pringy

75013

Hematology Service - Hopital La Pitié Salpetrière, Paris

75181

Hematology Unit - Hopital Hotel Dieu, Paris

75571

Hematology Unit - Hopital Saint Antoine, Paris

75743

AP-HP Hôpital Necker - Enfants Malades, Paris

76038

Hematology Unit - CH Becquerel, Rouen

77100

Hematology Unit CH Meaux, Meaux

78157

Hôpital André Mignot Centre Hospitalier de Versailles, Versailles

80054

CHU Sud, Amiens

84902

Hematology Service - CH Avignon, Avignon

85925

Hematology Unit CHD Vendée, La Roche-sur-Yon

86000

Hematology Unit CHU La Miletrie, Poitiers

87042

Hematology Unit CHU Dupuytren, Limoges

91110

Hematology Service CHSF, Corbeil-Essonnes

92141

Hopital Inter-Armées Percy, Clamart

93009

Hematology Unit - HOpital Avicienne, Bobigny

94000

CHU Henri Mondor Lymphoid Hemopathy Unit, Créteil

95000

Hematology Unit CH René DUBOS, Pontoise

Unknown

Intern medecine Service - CH Antibes-Juan-les-Pins, Antibes

Hematology Service - CH de la cote basque, Bayonne

Internal Medicine - CHU Hotel Dieu, Nantes

Oncology Unit CH Antoine Lacassagne, Nice

Hematology Unit - Hopital Saint Louis, Paris

All Listed Sponsors
lead

Rennes University Hospital

OTHER

NCT01976182 - Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia | Biotech Hunter | Biotech Hunter