AERN study: Abscopal Effect of Radiotherapy and Nivolumab in anti-PD1 Pretreated Relapsed or Refractory classical Hodgkin Lymphoma - An international multicenter Phase II trial

Phase 2

Recruiting

Conditions: Hodgkin Lymphoma
Hodgkin's disease
mallignant lymphoma
10025319

Registration Number: NL-OMON54697

Lead Sponsor: niversity of Cologne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

- Relapsed/refractory cHL with progression while treated with an anti-PD1
antibody or
Relapsed/refractory cHL with stable disease for > 6 months as best response to
ongoing anti-PD1 antibody therapy
- At least two distinct FDG-avid HL-lesions with at least 5 cm distance between
them, and one of them considered eligible for irradiation with 20Gy
- One but the irradiated lesion has to be outside the 10% isodose in RT
planning confirmed by the Central Response Evaluation Panel (CREP)
- Age 18 years and older, all sexes

Exclusion Criteria

- Nodular lymphocyte-predominant HL or grey-zone lymphoma
- Evidence of active, non-infectious lung disorder with DLCOc < 50%
- History of long-term or ongoing ingestion of immunosuppressive agents >10mg
prednisone/d
- Any other serious disease or organ dysfunction which might impair protocol
treatment
Note: Patients on antiretroviral therapy (ART) with controlled HIV infection
(defined as sufficient ART compliance, non-measurable HIV and CD4+ T helper
cells > 200/µL) may be enrolled, if considered eligible for study treatment by
the investigator.
- Prior allogeneic stem-cell transplantation (alloSCT), if one or more of the
following conditions are met:
a. AlloSCT conducted <12 months prior to registration for the screening phase
b. Requiring continued immunosuppression beyond 7d) at registration for the
screening phase
c. History of acute graft-versus-host disease >= grade3
d. History of chronic graft-versus-host disease >= grade3

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Abscopal response rate (ARR-6) with abscopal response centrally confirmed as<br /><br>restaging result after RT to a single lesion and at least four but not more<br /><br>than six nivolumab infusions (RE-6 result)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall abscopal response rate (OARR)<br /><br><br /><br>Overall response rate (ORR)<br /><br><br /><br>Duration of response (DOR)<br /><br><br /><br>Progression-free survival (PFS)<br /><br><br /><br>Overall survival (OS)<br /><br><br /><br>Adverse events (AE)<br /><br><br /><br>Feasibility aspects<br /><br><br /><br>Quality of life (QoL) and life situation (LS) aspects<br /><br><br /><br>Correlative studies</p><br>