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PD-1 Inhibition in Advanced Myeloproliferative Neoplasms

NCT03065400 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-06-21

Study results available
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Summary

The purpose of this study is to test the effectiveness of a drug called pembrolizumab in patients with Myeloproliferative Neoplasm (MPN); chronic phase (MF-CP), accelerated phase (MPN-AP), or blast phase (MF-BP). Myelofibrosis neoplasm (MPN) is a group of diseases of the bone marrow in which excessive cells are produced.

Pembrolizumab also known as Keytruda is a drug that has recently been approved in the United Stated by the Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic melanoma and disease progression. Pembrolizumab is experimental in the treatment of MPN. The researchers want to find out what effects, good and /or bad it has on participants and the disease.

Participants qualify to take part in this research study if have been diagnosed with a MPN blood disorder called myelofibrosis (MF). Accelerated (10-19% blasts in the blood or bone marrow) and blast phase (\>20% blasts in the blood or bone marrow) MPN has been a difficult disease to treat. The term "blasts" refers to immature cells found in the bone marrow. They are not fully developed, and therefore, do not yet carry out any particular function within the body.

Funds for conducting this research are provided by Merck and Company, the manufacturer of the study drug pembrolizumab.

Conditions

  • Chronic Phase Myelofibrosis
  • Primary Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Polycythemia Vera

Interventions

DRUG

Pembrolizumab

200 mg of Pembolizumab administered via intravenous infusion over 30 mins given every 3 weeks

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Montefiore Medical Center

    collaborator OTHER

  • John Mascarenhas

    lead OTHER

Principal Investigators

  • John Mascarenhas, MD · Icahn School of Medicine at Mount Sinai

  • Gabriela Hobbs, MD · Harvard Medical School Massachussets General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2020-05-28
Completion
2020-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03065400 on ClinicalTrials.gov