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NCT04373083WithdrawnPhase 2

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial

Source: ClinicalTrials.gov · Last updated 15 Jan 2021

Reason given: Business Decision

Brief summary (registry, in English)

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL). Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.

Status (registry)
Withdrawn
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
0 (actual)
First submitted
15 Apr 2020
Start date
15 Nov 2020
Primary completion date
20 Dec 2022
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT04373083
EudraCT number
2017-004265-28

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior chemotherapy or radiation therapy
  • Concurrent disease precluding protocol treatment as defined in the protocol

Other illness

  • Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)

Lab values

  • Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)

Other

  • Pregnancy or breast-feeding
  • Non-compliance as defined in the protocol
    • Note: Other protocol-defined Inclusion/Exclusion criteria apply

Who the study is looking for

  • Histologically proven classical HL
  • First diagnosis, no previous treatment
  • Stage I-II without risk factors as defined in the protocol

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.