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

NCT04837859 | Recruiting Phase 2 DMC

• 1 other identifier: Uni-Koeln-4470
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the trial is to establish an individualized first-line treatment incorporating checkpoint inhibition for early-stage unfavorable cHL, which is effective and well tolerated.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  1 year

Study Arms (2)

Arm A age 18-60

EXPERIMENTAL

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.

Drug: Tislelizumab

Arm B Age 60+

EXPERIMENTAL

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.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

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

Arm A age 18-60; Arm B Age 60+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• large mediastinal mass
• extranodal lesion(s)
• elevated erythrocyte sedimentation rate
• ≥ 3 nodal areas

You may not qualify if:

• Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

1st Department of Medicine, Cologne University Hospital

Cologne, Germany

RECRUITING

MeSH Terms

Interventions

tislelizumab

Study Officials

• Paul Broeckelmann, Dr.

  1st Department of Medicine, Cologne Universit Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Fuchs

CONTACT

+49221478; ghsg@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv. Doz.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 24, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

DE (1)