Clinical trial • Phase III • Oncology|Haematology
Obinutuzumab for Follicular lymphoma (early stage)
Phase III trial of Obinutuzumab for Follicular lymphoma (early stage).
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Follicular lymphoma (early stage)
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 18-12-2023
- First CTIS Authorization Date
- 25-01-2024
Trial design
Standard dose (24 Gy) involved site (IS) radiotherapy (RT) plus Rituximab versus low-dose (4 Gy) IS RT in combination with Obinutuzumab (no specific trial drug dosing schedule stated in the available CTIS data)-controlled Phase III trial across 21 sites in Germany.
- Comparator
- Standard dose (24 Gy) involved site (IS) radiotherapy (RT) plus Rituximab versus low-dose (4 Gy) IS RT in combination with Obinutuzumab (no specific trial drug dosing schedule stated in the available CTIS data)
- Target Sample Size
- 130
- Trial Duration For Participant
- 730
Eligibility
Recruits 130 Vulnerable population flag is selected (isVulnerablePopulationSelected: true). Inclusion requires written informed consent and capability to understand the trial ('Written informed consent and willingness to cooperate during the course of the trial'; 'Capability to understand the intention and the consequences of the clinical trial'). Subject information and informed consent forms are listed among documents (L1_FORTPlus_Patienteninformation _Einwilligungserklarung; L1_FORTplus_IC_adults_TC). No provisions for assent or minor consent are provided; age eligibility is ≥18 years..
- Pregnancy Exclusion
- Pregnancy / lactation
- Vulnerable Population
- Vulnerable population flag is selected (isVulnerablePopulationSelected: true). Inclusion requires written informed consent and capability to understand the trial ('Written informed consent and willingness to cooperate during the course of the trial'; 'Capability to understand the intention and the consequences of the clinical trial'). Subject information and informed consent forms are listed among documents (L1_FORTPlus_Patienteninformation _Einwilligungserklarung; L1_FORTplus_IC_adults_TC). No provisions for assent or minor consent are provided; age eligibility is ≥18 years.
Inclusion criteria
- {"criterion_text":"-Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2016)"}
- {"criterion_text":"-Adequate contraception for men and women of childbearing age during therapy and 18 months thereafter"}
- {"criterion_text":"-Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)"}
- {"criterion_text":"-Age: ≥18 years"}
- {"criterion_text":"-ECOG: 0-2"}
- {"criterion_text":"-Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging"}
- {"criterion_text":"-Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)"}
- {"criterion_text":"-Written informed consent and willingness to cooperate during the course of the trial"}
- {"criterion_text":"-Adequate bone marrow capacity: ANC ≥ 1.5 x 103/ml, thrombocytes ≥ 100000 x 10 3/ml, hemoglobin ≥ 10 g/dL"}
- {"criterion_text":"-Capability to understand the intention and the consequences of the clinical trial"}
Exclusion criteria
- {"criterion_text":"-Extra nodal manifestation of follicular lymphoma"}
- {"criterion_text":"-Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed >3 years ago)"}
- {"criterion_text":"-Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease"}
- {"criterion_text":"-Severe psychiatric disease"}
- {"criterion_text":"-Pregnancy / lactation"}
- {"criterion_text":"-Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug"}
- {"criterion_text":"-Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)"}
- {"criterion_text":"-Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial"}
- {"criterion_text":"-Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 L/min"}
- {"criterion_text":"-AST or ALT > 2.5 × ULN"}
- {"criterion_text":"-Total bilirubin ≥ 1.5 × ULN"}
- {"criterion_text":"-INR > 1.5 × ULN"}
- {"criterion_text":"-PTT or aPTT > 1.5 × the ULN"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)","definition_or_measurement_approach":"Assessed by CT, centrally reviewed"}
Secondary endpoints
- {"endpoint_text":"-Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI","definition_or_measurement_approach":"Assessed by CT/MRI"}
- {"endpoint_text":"-Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDGPET/ CT (centrally reviewed)","definition_or_measurement_approach":"Assessed by FDG-PET/CT, centrally reviewed"}
- {"endpoint_text":"-Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start)","definition_or_measurement_approach":"Time-to-event PFS measured up to 2 years after individual treatment start"}
- {"endpoint_text":"-PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start)","definition_or_measurement_approach":"Time-to-event PFS for this subgroup measured up to 2 years after individual treatment start"}
- {"endpoint_text":"-Toxicity (NCI-CTC criteria, version 5) of all patients","definition_or_measurement_approach":"Adverse events graded per NCI-CTC v5"}
- {"endpoint_text":"-Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits.","definition_or_measurement_approach":"Relapse incidence and recurrence pattern assessed at follow-up visits"}
- {"endpoint_text":"-Overall survival (OS) of each treatment arm (2 years)","definition_or_measurement_approach":"Overall survival measured up to 2 years"}
- {"endpoint_text":"-Quality of life according EORTC QLQ C30 and FACT-Lym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)","definition_or_measurement_approach":"Patient-reported QoL using EORTC QLQ-C30 and FACT-Lym at specified timepoints"}
Recruitment
- Planned Sample Size
- 130
- Recruitment Window Months
- 89
- Consent Approach
- Written informed consent required from participants ('Written informed consent and willingness to cooperate during the course of the trial'). Age eligibility is ≥18 years and adult-specific informed consent documents are listed (L1_FORTPlus_Patienteninformation _Einwilligungserklarung; L1_FORTplus_IC_adults_TC). No assent procedures or minor consent described. Languages of consent not specified in the available data.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 130
Germany
- Earliest CTIS Part Ii Submission Date
- 17-01-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 842
- Number Of Sites
- 21
- Number Of Participants
- 130
Sites
- Site Name
- Vivantes MVZ GmbH
- Department Name
- Haematologie und Onkologie
- Contact Person Name
- Christian Scholz
- Contact Person Email
- christianw.scholz@vivantes.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Strahlentherapie und Radioonkologie
- Contact Person Name
- Alev Altay-Langguth
- Contact Person Email
- Alev.Altaylangguth@med.uni-muenchen.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik III
- Contact Person Name
- Martin Dreyling
- Contact Person Email
- martin.dreyling@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Radioonkologie
- Contact Person Name
- Cihan Gani
- Contact Person Email
- cihan.gani@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Innere Medizin II
- Contact Person Name
- Stefan Wirths
- Contact Person Email
- Stefan.Wirths@med.uni-tuebingen.de
- Site Name
- Vivantes MVZ GmbH
- Department Name
- RadioOnkologie
- Contact Person Name
- Axel Madlung
- Contact Person Email
- axel.madlung@mvz-charite-vivantes.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Strahlentherapie
- Contact Person Name
- Thomas Gauler
- Contact Person Email
- Thomas.Gauler@uk-essen.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Strahlentherapie und Radioonkologie
- Contact Person Name
- Stefan Rieken
- Contact Person Email
- stefan.rieken@med.uni-goettingen.de
- Site Name
- Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
- Department Name
- Klinik für Onkologie und Hämatologie
- Contact Person Name
- Bernhard Heilmeier
- Contact Person Email
- Bernhard.Heilmeier@barmherzige-regensburg.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Strahlentherapie und Radioonkologie
- Contact Person Name
- Marc Münter
- Contact Person Email
- m.muenter@klinikum-stuttgart.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Radioonkologie und Strahlentherapie
- Contact Person Name
- Stephanie Combs
- Contact Person Email
- Stephanie.Combs@tum.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- RadioOnkologie
- Contact Person Name
- Klaus Herfarth
- Contact Person Email
- Klaus.Herfarth@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Hämatologie
- Contact Person Name
- Isabelle Krämer
- Contact Person Email
- isabelle.kraemer@med.uni-heidelberg.de
- Site Name
- Rostock University Medical Center
- Department Name
- Strahlentherapie
- Contact Person Name
- Guido Hildebrandt
- Contact Person Email
- guido.hildebrandt@med.uni-rostock.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Innere Medizin II
- Contact Person Name
- Christian Buske
- Contact Person Email
- christian.buske@uni-ulm.de
- Site Name
- Kliniken Maria Hilf GmbH Moenchengladbach
- Department Name
- Klinik für Strahlentherapie
- Contact Person Name
- Ursula Nestle
- Contact Person Email
- ursula.nestle@mariahilf.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Innere Medizin III
- Contact Person Name
- Maike Hefter
- Contact Person Email
- Maike.Hefter@mri.tum.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Hämatologie
- Contact Person Name
- Stephanie Sasse
- Contact Person Email
- stephanierosemarie.sasse@uk-essen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Strahlentherapie
- Contact Person Name
- Christian Schulz
- Contact Person Email
- Christian.Schulz@uksh.de
- Site Name
- Klinikum Oldenburg AöR
- Department Name
- Innere Medizin, Onkologie, Hämatologie
- Contact Person Name
- Christoph Kimmich
- Contact Person Email
- kimmich.christoph@klinikum-oldenburg
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Strahlentherapie und Onkologie
- Contact Person Name
- Cordula Petersen
- Contact Person Email
- cor.petersen@uke.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Heidelberg AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Gazyvaro 1,000 mg concentrate for solution for infusion.
- Active Substance
- Obinutuzumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation EU/1/14/937/001 (licensed)
- Maximum Dose
- max daily dose 1000 mg; max total dose 7000 mg
- Investigational Product Name
- MabThera 500 mg concentrate for solution for infusion
- Active Substance
- Rituximab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation EU/1/98/067/002 (licensed)
- Maximum Dose
- max daily dose 375 mg/m2; max total dose 3000 mg/m2
- Combination Treatment
- Yes
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