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CCTL019H2301 - BELINDA

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CCTL019H23012016-002966-29

Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)

Status: Active

Purpose / Objectives

Primary Outcome

The primary objective of this study is to compare tisagenlecleucel therapy to SOC therapy with respect to event free survival (EFS) as assessed by a blinded independent review committee (BIRC). EFS is defined as:

  1. progression (as per Lugano criteria) at or after the 11-week assessment;

  2. stable disease at or after 11 weeks; or

  3. death at any time.

Secondary Outcomes

  • To compare tisagenlecleucel therapy to SOC with respect to PFS by local investigator.

  • To compare tisagenlecleucel therapy to SOC with respect to overall survival (OS).

  • To compare tisagenlecleucel therapy to SOC with respect to overall response rate (ORR) and duration of response (DOR) by BIRC and local investigator.

  • To evaluate safety and tolerability of tisagenlecleucel versus SOC.

  • To describe the Patient Reported Outcome (PRO) in the two treatment arms according to SF-36 v2, FACT-Lym, and EQ-5D-5L.

  • Evaluate efficacy and safety of both treatment arms in histological subgroups (DLBCL, NOS, FL3B, other) and molecular subgroups (e.g., GCB, ABC, other)

  • To assess the patients treated with tisagenlecleucel with respect to the following objectives:

Characterize the in vivo cellular kinetics (levels, expansion, persistence) of tisagenlecleucel transduced cells into target tissues (blood, bone marrow, cerebral spinal fluid and other tissues if available), as measured by qPCR summarized by clinical response

Characterize immunogenicity including pre-existing (pre-dose) and post- tisagenlecleucel infusion in patients treated with tisagenlecleucel for each treatment arm

Assess presence of RCL in patients receiving tisagenlecleucel.

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

  • Histologically confirmed, aggressive B-cell NHL at relapse/progression after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes defined in the protocol
  • Relapse or progression within 12 months from last dose of rituximab and anthracycline containing frontline therapy or refractory (have not achieved a CR or PR).

  • Measurable disease:

    • Nodal lesions >15 mm in the long axis, regardless of the length of the short axis, and/or
    • Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) >10 mm in long AND short axis
  • ECOG performance status 0 or 1

  • Adequate organ function

[...]

Exclusion criteria

  • Prior treatment with anti-CD19 therapy or any prior gene therapy product
  • Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was >4 weeks before randomization
  • Prior allogeneic HSCT
  • Uncontrolled acute life threatening infection
  • Any cardiovascular conditions defined in the protocol
  • Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré Syndrome (GBS), Amyotrophic Lateral Sclerosis (ALS))

[...]

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Double-blind

Intervention

  • Arm A: A single dose of 0.6 to 6.0 × 108 of autologous tisagenlecleucel transduced T-cells administered via intravenous infusion.

  • Arm B: SOC immunochemotherapy including, in suitable patients, autologous stem cell transplant, as per local Guidelines.
  • Cross-over to the other treatment arm, is allowed at any time after 11 weeks from randomization after confirmed SD/PD by BIRC.

Documents (password protected)

Responsibilities in overall trial

Novartis Pharma GmbH

  • Tel. 0911 2730
  • Fax 0911 27312683

National Coordinating Investigator

Prof. Dr. med. Peter Borchmann

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Prof. Dr. med. Peter Borchmann

Deputy of Principal Investigator

  • PD Dr. Dr. med. Udo Holtick
  • Priv.-Doz. Dr. med. Bastian von Tresckow

Subinvestigator

  • PD Dr. med. Boris Böll
  • Dr. med. Anja Jühling
  • Hyatt Balke-Want
  • Dr. Philipp Gödel
  • Dr. med. Ron Jachimowicz
  • Dr. med. Katharina Leuchte
  • Johanna Prinz
  • Dr. med. Nadine Kutsch
  • Dr. med. Carmen Diana Herling

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