Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia
The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).
This is a multicenter open-label phase II study.
Primary objective:
To evaluate the efficacy of vismodegib in patients with relapsed/refractory B-cell lymphoma
and CLL as measured by the best overall response rate (ORR) during the treatment period.
Secondary objectives:
- To evaluate the tolerability and the safety of vismodegib in patients with
relapsed/refractory B-cell lymphoma and CLL
- To evaluate the efficacy of vismodegib in patients with relapsed/refractory B-cell
lymphoma and CLL by measuring the overall (OR) and complete response (CR) rate during
the study period, the maximum tumor shrinkage, the duration of response, the
progression-free survival (PFS) and the overall survival (OS).
- To examine the expression of GLI-1 and other Hedgehog (Hh) signalling components in the
tumor specimens before and during treatment with vismodegib and corresponding efficacy
in patients.
44 patients will be included in the study equally distributed into 4 cohorts according
to their histological subtype:
- Cohort 1: 11 patients with Diffuse large B-cell lymphomas (DLBCL)
- Cohort 2: 11 patients with "indolent" lymphomas (iNHL): Follicular (FL), mantle cell
(MCL) and marginal zone lymphoma (MZL) lymphoplasmacytic lymphoma (LPL)/ Waldenstrom
macroglobulinemia (WM), small lymphocytic lymphoma (SLL)
- Cohort 3: 11 patients with Primary central nervous system lymphomas (PCNSL)
- Cohort 4: 11 patients with Chronic lymphocytic leukemia (CLL).
After 28 days screening period (Baseline), each patient will be treated by Vismodegib 150 mg
per os during for a maximum of 12 months until disease progression, unacceptable toxicities,
patient consent withdrawal, death, reasons deemed by the treating physician or study
termination by the Sponsor.
Tumour assessment (clinical examination, laboratory tests, abdominal and chest CT scan (for
PCNSL only at baseline), +/- PET scan for DLBCL, +/- brain MRI and CSF examination and
ophthalmic examination for PCNSL, +/- bone marrow examination (except for PCNSL) will be
performed at baseline, and then every 2 months during the first 6 months of treatment, and
every 3 months thereafter until disease progression or up to 6 months after study treatment
stop.
Response to treatment will be assessed also by Pharmacodynamic study in tumor samples by
immunohistochimic and qPCR analysis at baseline and after one month of treatment with
vismodegib.
Pharmacokinetic studies (before and after 1 month of treatment) will also be performed.
After study treatment discontinuation, the patients will be followed up every 3 months until
disease progression or up to 6 months (after 1 year treatement).
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