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NCT06401356

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 2 years 6 months later.

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Dec 31, 2029 Show 4 more changesShow less
    • Eligibility criteria expanded, about 207 words
    • Interventions modified
    • Study description expanded, about 44 words
    • Site contacts updated at 5 of 15 sites
  2. Study sites revised (15)v6
  3. Lead sponsor: Constellation Pharmaceuticals to Novartis Pharmaceuticalsv5 Show 6 more changesShow less
    • Primary completion date: Jun 30, 2029 to Jun 2, 2027
    • Eligibility criteria expanded, about 173 words
    • Primary endpoints: 3 to 5
    • Study completion date: Jun 30, 2029 to Jun 30, 2027
    • Study description expanded, about 253 words
    • Site contacts updated at 6 of 15 sites
  4. Site contacts updated at 6 of 15 sitesv4
  5. Study sites: 1 to 15
    • Study description expanded, about 172 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 30, 2024 to Jun 30, 2029
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2024 to Aug 13, 2024
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Treatment-emergent adverse events (TEAEs) and serious TEAEs
Timeframe: 5 years
Survival Follow-up
Timeframe: 5 years
Duration of Response (DoR)
Timeframe: 5 years
Progression-free survival (PFS)
Timeframe: 5 years
Leukemia-free survival (LFS)
Timeframe: 5 years

Arms and interventions

Pelabresib and/or ruxolitinibExperimental

Participants who have previously received pelabresib alone or pelabresib in combination with ruxolitinib or ruxolitinib alone will continue to receive the same regimen as administered in the parent study. Additionally, the MANIFEST-2 (NCT04603495) control group (i.e., treated with placebo + ruxolitinib) patients, will be offered pelabresib combination treatment at the time of enrollment if the investigator sees any potential benefit of adding pelabresib to ruxolitinib.

Drugs: Pelabresib, Ruxolitinib

Sites

15 sites in 5 countries

United States 6, Italy 3, United Kingdom 3, Belgium 2, Netherlands 1