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NCT03895112 · ClinicalTrials.gov registry record · Phase 1

MPN-RC 118 AVID200 in Myelofibrosis

A Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by John Mascarenhas.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
1
Study location

NCT03895112: Completed Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, sponsored by John Mascarenhas.

NCT03895112 is a Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis that has completed, run by John Mascarenhas. The registered enrollment target is 21 participants, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03895112, a Phase 1 study of Primary Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis, has completed, sponsored by John Mascarenhas.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
1
Study location

Study Summary

Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. AVID200 is a drug that targets TGF-β1 and TGF-β3. The study team hypothesizes that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation and restore normal hematopoiesis. This is a first in human, open-label, multicenter, Phase I/Ib trial of AVID200. Patients must have intermediate-2 or higher primary myelofibrosis (PMF), post-essential thrombocythemia or polycythemia-vera related MF (Post ET/PV MF). This study will enroll up to 24 patients. AVID200 is delivered by IV infusion on day 1 of each 3 week cycle.

Primary Outcome

Cohorts of 3 patients with a maximum evaluable sample size of 12 patients and a target toxicity rate of 30% to estimate the MTD. Each cycle is 21 days.

Interventions

  • DRUG AVID200

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2019-02-15
Est. Completion 2022-05-16
Phase Phase 1
John Mascarenhas

11 total trials

What the finished NCT03895112 record still lists

NCT03895112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 120-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (82% lower).

The record links to 5 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 1 intervention - of which AVID200 is the first listed.

NCT03895112 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03895112 about?

NCT03895112 is a clinical study titled "MPN-RC 118 AVID200 in Myelofibrosis". Increased levels of TGF-β1 were detected in serum, plasma and BM and positively correlated with both grade of BMF and extent of leukemic cell infiltration in the marrow. TGF-β likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic ha...

What is the current status of trial NCT03895112?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-02-15. Estimated completion is 2022-05-16.

What conditions does trial NCT03895112 study?

This clinical trial studies the following conditions: Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-PV MF, Post ET MF.

What interventions are being tested in trial NCT03895112?

The interventions under investigation include: AVID200 (DRUG).

Who is sponsoring clinical trial NCT03895112?

This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03895112 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Primary Myelofibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03895112's enrollment target sits among peer trials

21 24th of 30 higher than 5 of 30 other Primary Myelofibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Primary Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03895112, the US trial registry maintained by the National Library of Medicine. NCT03895112 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.