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CLL13

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CLL132015-004936-36

A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinutuzumab (GA101) plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • The primary objective of the study is to evaluate the efficacy of obinutuzumab (GA101) plus veneto-clax (GVe) versus standard chemoimmunotherapy (BR/FCR) concerning MRD negativity measured by flow cytometry in peripheral blood (PB) approximately 15 month after start of therapy [MRD-Staging 3; MO15] and obinutuzumab plus ibrutinib plus venetoclax (GIVe) versus standard chemoimmunothera-py (BR/FCR) concerning progression free survival (PFS) in previously untreated, fit CLL patients with-out del(17p) or TP53 Mutation.

Secondary Outcomes

  • Efficacy parameters, particularly MRD negativity and PFS comparisons between all four treatment arms.
  • Overall response rate (ORR) [MO 3, 9, 13, 15] and CR / CRi rate [MO 3, 9, 13, 15] with regard to best response achieved will be measured and duration of response as well as the time to next CLL treatment will be quantified. Moreover, exploratory evaluations of potential associations between biomarkers and subject characteristics or outcome measures will be considered for the secondary endpoint analyses.
  • The incidence of safety parameters is another important endpoint with regards to type, frequency, and severity of adverse events (AEs) and adverse events of special interest (AESI) and their relationship to study treatment.
  • Patient related outcomes in terms of health-related quality will be measured by MARS and EORTC QLQ-C30 and QLQ-CLL16 questionnaires.
  • The evaluation of relationship between various baseline markers and clinical outcome parameters but also on the correlation between MRD in BM and PB, as well as MRD in BM and PFS/EFS/OS and MRD in PB and PFS/EFS/OS. Moreover, comparisons of the outcome between FCR and BR will be considered.

Diagnosis

Previously untreated, fit CLL patients without del(17p) or TP53 mutation.

Patient attributes

Age

65-

Inclusion criteria

  • Documented CLL requiring treatment according to iwCLL criteria.
  • Patients older than 65
  • Life expectancy ≥ 6 months.
  • Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements.
  • Adequate bone marrow function indicated by a platelet count >30.000/mm³ (unless direct-ly attributable to CLL infiltration of the bone marrow provenmarrowproven by bone marrow biopsy)
  • [...]

Exclusion criteria

  • Any prior CLL- specific- therapies (except for corticoid treatment administered due to neces-sary immediate intervention; within the last 10 days before start of study treatment only dose equivalents of 20 mg prednisolone are permitted).
  • Transformation of CLL (Richter’s transformation).
  • Detected del(17p) or TP53 mutation.
  • Patients with a history of confirmed PML.
  • Any comorbidity or organ system impairment rated with a single CIRS (cumulative illness rat-ing scale) score of 4, (excluding the eyes/ ears /nose/throat/larynx organ system), a total CIRS score of more than 6 or any other life-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion could comprise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tablets or im-paired resorption in the gastrointestinal tract).
  • [...]

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Four-arm
  • Open Label

Intervention

  • The study aims to investigate the efficacy of standard chemoimmuno-therapy (BR/FCR) versus rituximab plus venetoclax (RVe) versus obinutuzumab plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in previously untreated, fit CLL patients without del(17p) or TP53 Mutation.

Documents (password protected)

Responsibilities in overall trial

Universität zu Köln

  • Tel. +49 (0)221 478 0

National Coordinating Investigator

Prof. Dr. med. Barbara Eichhorst

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active (Recruitment Closed)

Principal Investigator

Prof. Dr. med. Barbara Eichhorst

Deputy of Principal Investigator

  • Dr. med. Julia von Tresckow, geb. Kilp
  • Univ.-Prof. Dr. med. Michael Hallek

Subinvestigator

  • Dr. med. Othman Al-Sawaf
  • Hyatt Balke-Want
  • Dr. med. Birgit Cremer
  • Dr. med. Petra Langerbeins, geb. Jenke
  • Dr. med. Armin Tuchscherer
  • Univ.-Prof. Dr. med. Dr. rer.-nat. Roland Ullrich
  • Priv.-Doz. Dr. med. Bastian von Tresckow
  • PD Dr. med. Thomas Zander
  • Prof. Dr. med. Christian Pallasch
  • PD Dr. med. Stephanie Sasse
  • Dr. med. Paula Cramer
  • Dr. med. Janine Böll, geb. Schwamb
  • Dr. med. Moritz Fürstenau
  • Dr. med. Nadine Kutsch
  • Dr. med. Anja Jühling
  • Dr. med. Sibylle Christiane Mellinghoff
  • Florian Simon
  • Johanna Prinz
  • Dr. Stefanie Kreissl
  • Dr. med. Carmen Diana Herling
  • Dr. med. Ron Jachimowicz

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