Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macro… (NCT02962401) | Clinical Trial Compass
CompletedPhase 2
Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia
France50 participantsStarted 2017-03-07
Plain-language summary
Prospective national multicenter open label phase II Remodel WM3 trial
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older
* Confirmed CD20 positive WM, according to the recommendations of the 2nd Workshop on WM.
* Presence of at least one criterion for initiation of therapy, according to the 2nd Workshop on WM.
* Recurrent fever, night sweats, weight loss, fatigue
* Hyperviscosity
* Lympadenopathy which is either symptomatic or bulky more or equal to 5cm in maximum diameter
* Symptomatic hepatomegaly and/or splenomegaly
* Symptomatic organomegaly and/or organ or tissue infiltration
* Peripheral neuropathy due to WM
* Symptomatic cryoglobulinemia
* Cold agglutinin anemia
* Immune hemolytic anemia and/or thrombocytopenia
* Nephropathy related to WM
* Amyloidosis related to WM
* Hemoglobin less or equal than 10g dL
* Platelet count less than 100 109 L
* Prior treatment for WM comprising at least one regimen containing a therapeutic anti CD20 monoclonal antibody rituximab administered for more or equal than 2 doses of antibody treatment and or a therapeutic chemotherapy, alkylating agent, purine analogue, bendamustine administered for more or equal than 2 cycles of treatment
* Patients may be either relapsing progressing at least 6 months after the last administration of first line or subsequent treatment or refractory progressing on or within 6 months of first line or subsequent treatment
* Number of prior regimens per lines 1 to 3
* Life expectancy more than 3 months.
* ECOG less or equal than 2.
* Meet the following pretreatment laboratory criteria at …