A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic L… (NCT02537613) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
United States54 participantsStarted 2015-12
Plain-language summary
This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma as per IW-CLL 2008 criteria and require therapy based on meeting at least one of the following criteria:
* Evidence of progressive marrow failure with anemia (hemoglobin \<11.0 g/L) and/or thrombocytopenia (platelets \<100 x 10\^9/L)
* Massive (≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly
* Massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy
* Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of \<6 months.
* Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids
* Constitutional symptoms, defined as 1 or more of the following:
* unintentional weight loss \>10% within 6 months prior to screening
* significant fatigue (inability to work or perform usual activities) fevers \>100.5° F or 38.0° C for 2 or more weeks prior to screening without evidence of infection
* night sweats for more than 1 month prior to screening without evidence of infection
* Relapsed after or refractory to at least one prior Chronic Lymphocytic Leukemia-directed therapy
* Age greater than or equal to 18 years
* ECOG Performance Status \<2
* Heme criteria at screening, unless significant bone marrow involvement of Chronic Lymphocytic Leukemia confirmed on biopsy:
* Absolute Neutrophil Count (ANC) ≥500 cells/mm3 (0.5 x 1…
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0