Early Stage Follicular LymphOma and RadioTherapy PLUS anti-CD20 Antibody

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Heidelberg AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

4 Jul 2022 → ongoing

Decision date (initial)

2024-01-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-509278-41-00

EudraCT number

2021-000362-15

ClinicalTrials.gov

NCT05045664

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

Evaluation of the rate of morphologic CR in week 18 after standard dose (24 Gy) involved site (IS) radiotherapy (RT) plus Rituximab or low-dose (4 Gy) IS RT in combination with Obinutuzumab in early stage nodal follicular lymphoma (centrally reviewed)

Secondary objectives 8

1. Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI
2. Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDG-PET/CT (centrally reviewed)
3. Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start)
4. PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start)
5. Toxicity (NCI-CTC criteria, version 5) of all patients
6. Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits.
7. Overall survival (OS) of each treatment arm (2 years)
8. Quality of life according EORTC QLQ C30 and FACTLym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)

Conditions and MedDRA coding

Early Stage Follicular LymphOma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2016)
2. Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)
3. Age: ≥18 years
4. ECOG: 0-2
5. Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging
6. Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)
7. Written informed consent and willingness to cooperate during the course of the trial
8. Adequate bone marrow capacity: ANC ≥ 1.5 x 103/ml, thrombocytes ≥ 100000 x 10 3/ml, hemoglobin ≥ 10 g/dL
9. Capability to understand the intention and the consequences of the clinical trial
10. Adequate contraception for men and women of childbearing age during therapy and 18 months thereafter

Exclusion criteria 13

1. Extra nodal manifestation of follicular lymphoma
2. 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)
3. 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
4. Severe psychiatric disease
5. Pregnancy / lactation
6. Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug
7. Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)
8. Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial
9. Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min
10. AST or ALT > 2.5 × ULN
11. Total bilirubin ≥ 1.5 × ULN
12. INR > 1.5 × ULN
13. PTT or aPTT > 1.5 × the ULN

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)

Secondary endpoints 8

1. Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI
2. Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDGPET/ CT (centrally reviewed)
3. Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start)
4. PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start)
5. Toxicity (NCI-CTC criteria, version 5) of all patients
6. Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits.
7. Overall survival (OS) of each treatment arm (2 years)
8. Quality of life according EORTC QLQ C30 and FACT-Lym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Heidelberg AöR

Sponsor organisation

Universitaetsklinikum Heidelberg AöR

Address

Im Neuenheimer Feld 672, Neuenheim Neuenheim

City

Heidelberg

Postcode

69120

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Heidelberg AöR

Contact name

Prof. Dr. Klaus Herfarth

Public contact point

Organisation

Universitaetsklinikum Heidelberg AöR

Contact name

Prof. Dr. Klaus Herfarth

Locations

1 EU/EEA country · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications