jaebl.blogg.se - Irc 125

#Irc 125 trial

Ī secured external environment with username, password, and RSA code. For more information, please visit our website at. Qualified external researchers may request IPD for this study after study completion. Individual Participant Data (IPD) Sharing Statement: No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Orsola Malpighiįondazione Centro San Raffaele del Monte Taborīarrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. Klinikum der Universität München-GroßhadernĪzienda Ospedaliera di Bologna - Policlinico S. Madison, Wisconsin, United States, 53792-5156 Seattle, Washington, United States, 98109

Nashville, Tennessee, United States, 37203Ĭharlottesville, Virginia, United States, 22908 Philadelphia, Pennsylvania, United States, 19104Ĭolumbia, South Carolina, United States, 29210Ĭhattanooga, Tennessee, United States, 37404 The Ohio State University Comprehensive Cancer Center Weill Cornell -New York Presbyterian Hospital

New Brunswick, New Jersey, United States, 08901-1914 University of Medicine and Dentistry of NJ Hackensack, New Jersey, United States, 07601 John Theurer Cancer Center Hackensack University Medical Center Saint Louis, Missouri, United States, 63110 Stanford, California, United States, 94035-5796īoynton Beach, Florida, United States, 33435Ītlanta, Georgia, United States, 30322-1013 Santa Maria, California, United States, 93454 Los Angeles, California, United States, 90095 Long Beach, California, United States, 90813-3244 Note: Other protocol defined Inclusion/Exclusion criteria may apply.įullerton, California, United States, 92835

Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results.

#Irc 125 trial

Concurrent participation in another therapeutic treatment trial.

Exposure to another investigational drug within 3 weeks prior to start of study treatment.

Participant may be using topical or inhaled corticosteroids.

Ongoing immunosuppressive therapy, including systemic corticosteroids.

History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension.Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment.History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years.Known histological transformation from iNHL to diffuse large B-cell lymphoma.

Central nervous system or leptomeningeal lymphoma.

Willingness and ability to provide written informed consent and to comply with the protocol requirements.

For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods.

Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2.

Lymphoma that is refractory to rituximab and to an alkylating agent.

Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL.

Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.

Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL.

Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal).

Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM).

Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration.

Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:

Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group performance score of 0, 1, or 2).

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