Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

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NCT-Nummer:
NCT04837859

Studienbeginn:
Dezember 2023

Letztes Update:
14.09.2023

Wirkstoff:
Tislelizumab

Indikation (Clinical Trials):
Lymphoma, Hodgkin Disease

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University of Cologne

Collaborator:
-

Studienleiter

Paul Broeckelmann, Dr.
Principal Investigator
1st Department of Medicine, Cologne Universit Hospital

Kontakt

Michael Fuchs
Kontakt:
Phone: +49221478
Phone (ext.): 88160
E-Mail: ghsg@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

1st Department of Medicine, Cologne University Hospital
Cologne
(Nordrhein-Westfalen)
Germany» Google-Maps

Studien-Informationen

Detailed Description:

Programmed cell death protein-1 (PD-1) blockade is highly effective and well tolerated in

relapsed or refractory cHL and has also demonstrated efficacy in the first-line treatment of

cHL in combination with doxorubicin, vinblastine, and dacarbazine (AVD) in the phase II GHSG

NIVAHL trial. A relevant proportion of patients achieved an early metabolic complete

remission (CR) with anti-PD-1 monotherapy and might not require standard chemo- or

radiotherapy. Limiting therapy-associated short- and long-term side effects of these

conventional treatments including impaired quality of life, second primary malignancies or

organ damage is of utmost importance in the predominantly young cHL patients. This trial will

hence further reduce treatment intensity and provide a chemo- and radiotherapy-free therapy

to optimally responding patients.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age 18-60 for the main trial cohort

- Age ≥ 61 years and eligible for AVD as determined by CIRS-G score and investigator for

the exploratory cohort

- First diagnosis of treatment-naïve cHL

- Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d,

stage IIB with risk factors c-d):

1. large mediastinal mass

2. extranodal lesion(s)

3. elevated erythrocyte sedimentation rate

4. ≥ 3 nodal areas

Exclusion Criteria:

- Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or

central nervous system involvement of lymphoma

Studien-Rationale

Primary outcome:

1. Progression Free Survival (Time Frame - 1 year)

Studien-Arme

Experimental: Arm A age 18-60
Patients at the age of 18-60 years at enrollment will receive 2 initial doses of 200 mg tislelizumab in 21-day intervals followed by an interim positron emission tomography (PET-2). Following a PET-guided approach, patients with a negative PET-2 (i.e. Deauville score 1-3) according to central review will continue receiving tislelizumab for another 4 doses of 300 mg in 28-day intervals. Patients with a positive PET-2 (i.e. Deauville score >3) will receive 4 cycles of combined 300 mg tislelizumab on day 1 and AVD chemotherapy on day 1 and 15 in 28-day cycles (4x T-AVD). For all patients, 30 Gy involved-site radiotherapy (IS-RT) will only be applied in case of PET positivity after completion of (chemo-) immunotherapy.
Experimental: Arm B Age 60+
Patients above the age of 60 years will be enrolled in a separate, exploratory cohort and receive PET-guided treatment with tislelizumab or T-AVD as described above. However, all patients in the exploratory cohort for older patients will receive consolidating 30 Gy IS-RT.

Geprüfte Regime

Tislelizumab:
age 18-60: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT if PET positive resudues after the end of Tis or Tis-AVD age 60+: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT for all patients

Quelle: ClinicalTrials.gov

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