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NCT03681561

Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 32 days later.

See at-risk trials from Veronika Bachanova

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Record History

All 22 versions: 20 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 29 words
    • Primary completion pushed from Sep 2026 to Nov 2026
    • Secondary endpoints: details revised at 5 of 5 entries
  2. Site contacts updated at 1 of 6 sitesv21
  3. Primary completion pushed from Mar 2026 to Sep 2026v20
  4. Eligibility criteria shortened, about 36 wordsv19
  5. Study sites: 5 to 6
    • Primary completion date: Dec 2025 to Mar 2026
    v18
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Jul 2025 to Dec 2025v17
  2. Primary completion date: Sep 2024 to Jul 2025
    • Study completion date: Dec 2026 to Jul 2027
    v16
  3. Primary completion date: Aug 2024 to Sep 2024v15
  4. Primary completion date: Jan 2024 to Aug 2024
    • Site details revised at 1 of 5 sites
    v14
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 4 to 5
    v13
  6. Phase: Phase 1 to Phase 1/2v12 Show 5 more changesShow less
    • Enrollment target: 20 to 54
    • Eligibility criteria expanded, about 24 words
    • Primary endpoints: 1 to 2
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study arms: 1 to 2
  7. Phase: Phase 1/2 to Phase 1
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 5 to 4
    v11
  8. Study sites: 4 to 5v10
  9. Primary completion date: Sep 2021 to Jan 2024
    • Study completion date: Mar 2024 to Dec 2026
    v9
  10. Eligibility criteria expanded, about 25 wordsv6
  11. Eligibility criteria expanded, about 38 wordsv5
  12. Primary completion date: Sep 2020 to Sep 2021v4
  13. Site contacts updated at 1 of 4 sitesv3
  14. Study sites: 1 to 4v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Maximum Tolerated Dose
Timeframe: 24 months
Overall Disease Control
Timeframe: 24 months

Secondary (5)

Overall Response Rate
Progression Free Survival
Duration of Response
Overall Survival
Frequency and Severity of Adverse Events as assessed by CTCAE v4.0

Arms and interventions

Phase I:Ruxolitinib and NivolumabExperimental

Participants will receive ruxolitinib at their assigned dose taken orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.

Phase II: Ruxolitinib and NivolumabExperimental

Participants will receive ruxolitinib at 20mg orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.

Drugs: Ruxolitinib, Nivolumab

Sites

6 sites in 1 country