Active — Not RecruitingPhase 3

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment

United States327 participantsStarted 2021-04-12

Plain-language summary

The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibitor treatment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. no decrease in spleen volume (\< 10% by MRI or CT) from the start of treatment with JAK-inhibitor
✓. no decrease in spleen size (\< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor
✓. no decrease in symptoms (\< 20% by Myelofibrosis Symptom Assessment Form \[MFSAF\] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor
✓. a score of at least 15 on TSS assessed using the MFSAF v4.0 during screening.
✓. Increase in spleen volume from time of best response by 25% measured by MRI or CT, or
✓. Increase in spleen size by palpation, CT, or ultrasound

What they're measuring

Overall survival (OS)

Timeframe: Baseline (Day 1) until End of Study (EOS) (approximately 3 years )]

Trial details

NCT IDNCT04576156

SponsorGeron Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06-30

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