Last updated on September 2018

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Large Granular Lymphocytes Leukemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Common criteria of LGL leukemia: the diagnosis is based on a chronic LGL peripheral blood expansion (>0.5x109/L), usually lasting more than 6 months
  • Specific criteria for T-LGL leukemia or NK-LGL lymphocytosis or chronic NK-LGL
    leukemia
  • Specific criteria for T-LGL leukemia:
  • Expression of LGL surface markers compatible with an activated T-cell (commonly alpha-beta+/CD3+/CD8+/CD57+ and/or CD16+) phenotype or gamma-delta+ T cells;
  • Clonal rearrangement of TCR gene using PCR or specific and clonal V expression using FCM.
  • Specific criteria for NK-LGL lymphocytosis or chronic NK LGL leukemia:
  • Expression of LGL surface markers compatible with a NK cell (commonly CD3-/CD8+/CD16+ and/or CD16+/CD56+) phenotype;
  • CD56+ or CD16+ NK cells greater than 0.75x109/L;
  • The term of chronic NK-LGL lymphocytosis is used for patients with chronic illness (NB: patients with massive tissue LGL infiltration of the spleen, liver and bone marrow and presenting aggressive clinical behavior are considered as having aggressive NK-LGL leukemia and should not be included).
  • Age above 18 years
  • ECOG performance status of 0-2
  • Life expectancy of at least 1 year
  • Lack of previous treatment (except with G-CSF or transfusions)
  • At least one indication of treatment:
  • Isolated severe neutropenia (ANC <0.5x109/L) or neutropenia (ANC <1.5x109/L) with two or more infections requiring antibiotics;
  • Anemia (whatever the underlying mechanism: pure red cell aplasia or marrow infiltration) requiring transfusions greater than 2 units for two months prior to inclusion, or symptomatic anemia (hemoglobin <10g/dl) with impairment of the quality of life;
  • Associated complications such as systemic diseases or auto-immune diseases (i.e. recurrent uveitis, cutaneous vasculitis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, rheumatoid arthritis resistant to steroids and/or immunomodulator agents (colchicin, disulone, hydrochloroquine)) and justifying a treatment with methotrexate or cyclophosphamide
  • Written informed consent

Exclusion Criteria:

  • Inability to understand or to follow study procedures
  • Prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Other serious medical illnesses, such as hepatic, renal, cardiac, pulmonary, neurologic, or metabolic disease that would preclude the patient's ability to tolerate methotrexate, cyclophosphamide, or ciclosporine A
  • Reactive LGL lymphocytosis (i.e. after viral infection)
  • ALAT/ASAT or alkalin phosphatases >3 times normal values
  • Creatinine clairance <50 ml/min
  • Serologic evidence of HIV, hepatitis C or hepatitis B infection
  • Non effective contraception
  • Positive pregnancy test
  • Nursing woman

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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