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About
We hypothesize that GA101 - Obinutuzumab in combination with HDMP is well tolerated and will induce similar if not higher response rates than the ones observed in Rituximab plus HDMP studies (Castro et al., 2009, Castro et al., 2008).
Full description
This is an open label phase Ib/II clinical trial to determine the safety and clinical activity of the GA101 - Obinutuzumab in combination with high-dose methylprednisone (HDMP). We will evaluate dose-limiting toxicities (DLTs) during the first month of therapy as part of the phase Ib of this study. In the phase II we will determine response rate in an intention to treat analysis. In this study we will include CLL patients that have never received treatment as well as patients that have failed previous treatments.
Enrollment
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Inclusion criteria
Diagnosis of CLL
Indication for treatment as defined by the IWCLL Guidelines (Hallek et al., 2008b).
Males and females 18 years of age and older.
Laboratory parameters as specified below:
ECOG Performance Status < 2, unless the decline of the performance status is considered to be related to CLL symptoms.
Anticipated survival of at least 6 months.
Subjects can be enrolled and treated under this protocol regardless of their CLL treatment history or number of previous treatments. In addition, subjects with history of allogeneic stem cell transplant can be enrolled and treated unless they have active manifestations of graft vs. host disease (GVHD) or chronic illness or infections that will prevent them from completing the study.
Previously untreated subjects that meet ANY of the following criteria: A. Documented refusal to be treated with chemotherapy agents. B. Subjects that are not candidates for treatment with chemotherapy based on poor performance status (ECOG ≥ 2), advance age (> 65 years), Cumulative Illness Rating Scale (CIRS score) ≥ 6 or cytopenias.
Effective contraception is required while receiving GA101 - Obinutuzumab. For women of childbearing potential and men, effective contraception is required while receiving GA101 - Obinutuzumab and for 365 days (12 months) after the last dose of the study drug.
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
Subjects must give written informed consent to participate in this trial.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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