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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: Prospective, Sequential Multiple Assignment, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia

Study ID: NCT01976182

Study Description

Brief Summary: LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : 1. to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T/NK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease 2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious 3. to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy 4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.

Detailed Description: Large Granular Lymphocyte (LGL) leukemia is a clonal disorder involving tissue invasion of marrow, spleen and liver. Clinical presentation is dominated by recurrent infections associated with neutropenia, anemia, splenomegaly, and auto-immune diseases, particularly rheumatoid arthritis. Both T cell and NK cell subtypes of LGL leukemia are indolent disease and considered as a chronic illness and lead to a treatment in more than 60% of patients. LGL leukemia displays a chronic clinical course. Recommendations regarding therapy are similar for both subtypes. Indications for treatment include 1) severe neutropenia (ANC \<500 mm3); 2) neutropenia (ANC \<1500mm3) with symptomatic recurrent infections; 3) symptomatic or transfusion-dependent anemia and 4) associated autoimmune conditions requiring therapy, most often rheumatoid arthritis. There is no standard treatment for patients with LGL leukemia. The numerous case reports published do not provide a consensus for a particular treatment. All the six largest series published in the literature so far (collecting data on more than 40 patients) are retrospective. Immunosuppressive therapy remains the foundation of treatment including single three agents i.e. methotrexate, oral cyclophosphamide and ciclosporin A. However prospective trials involving large numbers of patients have not been performed and no molecule has proven superiority over others. Invetigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. Combining the results of our series with those of the literature, invetigators estimate that overall response rate and complete response rate are 55% and 30% with methotrexate, 60% and 50% with cyclophosphamide, and 55% and less than 20% with ciclosporine A, respectively. Thus, there are four objective in this study : 1. to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T/NK LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease 2. to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious 3. to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy 4. to evaluate the response rate according to the phenotypic subtype of LGL leukemia.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU Sud, Amiens, , France

CHU Angers, Angers, , France

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

Hematology Service - CH Avignon, Avignon, , France

Hematology Service - CH de la cote basque, Bayonne, , France

hematology service - CH Beauvais, Beauvais, , France

Hematology Service - CH Jean Minjoz, Besançon, , France

Hematology Service - CH Beziers, Beziers, , France

Hematology Unit - HOpital Avicienne, Bobigny, , France

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

Hematology Service - CH de Brest, Brest, , France

Hematology Service - CH François Baclesse, Caen, , France

hematology Service - CH Louis Pasteur, Chartres, , France

Centre Hospitalier de Cholet, Cholet, , France

Hopital Inter-Armées Percy, Clamart, , France

hematology Service - CHU Estaing, Clermont-Ferrand, , France

Hematology Service - Civils hospital, Colmar, , France

Hematology Service CHSF, Corbeil Essonnes, , France

CHU Henri Mondor Lymphoid Hemopathy Unit, Creteil, , France

Hematology Unit CH Michalon, Grenoble, , France

Hematology Unit CHD Vendée, La Roche sur Yon, , France

Hematology Unit CH LE MANS, Le Mans, , France

CH Robert Boulin, Libourne, , France

Hematology Unit CHRU Lille, Lille, , France

Hematology Unit CHU Dupuytren, Limoges, , France

CH de Bretagne Sud, Lorient, , France

Hematology Unit CHU La Conception, Marseille, , France

Hematology Unit - Institut Paoli-Calmettes, Marseille, , France

Hematology Unit CH Meaux, Meaux, , France

Hematology Unit CH Notre Dame Bon Secours, Metz, , France

Hematogy Unit CHU ST ELOI, Montpellier, , France

Hematology Unit CH E.MULLER, Mulhouse, , France

Internal Medicine - CHU Hotel Dieu, Nantes, , France

Oncology Unit CH Antoine Lacassagne, Nice, , France

hematology Unit CHU Caremeau, Nimes, , France

Hematology Unit - CHR Orleans, Orleans, , France

Hematology Service - Hopital La Pitié Salpetrière, Paris, , France

Hematology Unit - Hopital Hotel Dieu, Paris, , France

Hematology Unit - Hopital Saint Antoine, Paris, , France

AP-HP Hôpital Necker - Enfants Malades, Paris, , France

Hematology Unit - Hopital Saint Louis, Paris, , France

Hematology Unit Hopital Saint Jean, Perpignan, , France

Hematology Service- CH Haut Leveque, Pessac, , France

Hematology Unit CH LYON SUD, Pierre Benite, , France

Hematology Unit CHU La Miletrie, Poitiers, , France

Hematology Unit CH René DUBOS, Pontoise, , France

CH Annecy - Hematology Service, Pringy, , France

Hematology Unit- Hopital Robert Debré, Reims, , France

Hematology Service - CHU of Rennes, Rennes, , France

Hematology Unit - CH Becquerel, Rouen, , France

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

CH Saint Quentin Oncohematology, Saint Quentin, , France

CH Yves Lefoll, Saint-Brieuc, , France

Hematology Unit CHU Toulouse, Toulouse, , France

Hematology Unit CHU Bretonneau, Tours, , France

Hematology Unit Hopitaux de Brabois, Vandoeuvre les Nancy, , France

Intern Medecine Unit CHBA, Vannes, , France

Hôpital André Mignot Centre Hospitalier de Versailles, Versailles, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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