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Clinical Trials/EUCTR2014-000582-47-DE
EUCTR2014-000582-47-DE
Active, not recruiting
Phase 1

A prospective, open-label, multicenter phase-II-trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101 maintenance in CLL patients (CLL2-BCG-trial of the GCLLSG) - CLL2-BCG

niversity of Cologne0 sites62 target enrollmentFebruary 9, 2015
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DrugsBendamustineZydeligGazyvaro

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Cologne
Enrollment
62
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 9, 2015
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Cologne

Eligibility Criteria

Inclusion Criteria

  • •1\. relapsed/refractory CLL requiring treatment according to iwCLL criteria with at least one of the following features:
  • •\-del(17p)/TP53 mutation
  • •\-ineligibility for ibrutinib due to refractoriness, intolerance or contraindications to receive ibrutinib (e.g. intake of vitamin k antagonists)
  • •Patients must have recovered from acute toxicities of the previous treatment and pre\-treatment must be stopped within the following time periods before start of the study treatment in the CLL2\-BCG trial:
  • •\- chemotherapy within \= 28 days
  • •\- antibody treatment within \= 14 days
  • •\- kinase inhibitors, Bcl\-2\-antagonists or immunmodulatory agents within \= 3 days
  • •\- corticosteroids may be applied until the start of the BCG\-regimen, these have to be reduced to an equivalent of \= 20 mg prednisolone during treatment
  • •2\. Adequate hematologic function as indicated by a platelet count \= 25 x 10 9/L, a neutrophil count \= 1,0 x 10 9/L and a hemoglobin value \= 8\.0 g/dL, unless directly attributable to the patient´s CLL (e.g. bone marrow infiltration)
  • •3\. Adequate renal function as indicated by a creatinine clearance \= 30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24 hrs urine collection

Exclusion Criteria

  • •1\. Transformation of CLL (i.e. Richter’s transformation, pro\-lymphocytic leukemia)
  • •2\. Known central nervous system (CNS) involvement
  • •3\. Patients with confirmed PML
  • •4\. Malignancies other than CLL currently requiring systemic therapy
  • •5\. Active infection requiring systemic treatment
  • •6\.Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system or any other life\-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion \- could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tablets or impaired resorption in the gastrointestinal tract)
  • •7\. Ongoing inflammatory bowel disease
  • •8\. Ongoing drug induced pneumonitis
  • •9\. Use of investigational agents which would interfere with the study drug within 28 days prior to registration
  • •10\. Known hypersensitivity to GA101 (obinutuzumab), CAL\-101 (idelalisib) or any of the excipients

Outcomes

Primary Outcomes

Not specified

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