EUCTR2017-003334-82-NOActive, not recruitingPhase 1
Abscopal Effect of Radiotherapy and Nivolumab in anti-PD1 Pretreated Relapsed or Refractory classical Hodgkin Lymphoma - An international multicenter Phase II trial - AER
niversity of Cologne0 sites29 target enrollmentStarted: November 5, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 29
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 5cm 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, all sexes
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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
Investigators
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