Poly ICLC for Myeloproliferative Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Myeloproliferative Disorders+6 More
Poly ICLC - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be safely administered to patients with myeloproliferative neoplasms.

See full description

Eligible Conditions

  • Myeloproliferative Disorders
  • Essential Thrombocythemia (ET)
  • MPN
  • Agnogenic Myeloid Metaplasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myeloproliferative Disorders

Study Objectives

This trial is evaluating whether Poly ICLC will improve 1 primary outcome and 7 secondary outcomes in patients with Myeloproliferative Disorders. Measurement will happen over the course of Baseline through Week 32.

32 weeks
Number of Participants with Dose Limiting Toxicity (DLT)
Baseline and Week 32
Proportion of participants achieving response
Baseline through Week 32
Number of laboratory abnormalities
Week 55
Change in CALR VAF
Change in Immune Milieu Composite
Week 32
Number of Adverse Events
Week 55
Myelofibrosis Symptom Assessment Form (MF-SAFv4.0)
Proportion of participants who normalize their platelet number

Trial Safety

Safety Progress

1 of 3

Other trials for Myeloproliferative Disorders

Trial Design

1 Treatment Group

CALR mutated
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Poly ICLC is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

CALR mutatedpeptide-based vaccine in patients with myeloproliferative neoplasm (myelofibrosis and essential thrombocythemia) with CALR mutations
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly ICLC
2014
Completed Phase 2
~330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 32 and weeks 55 or 80
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 32 and weeks 55 or 80 for reporting.

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects must be ≥18 years of age at the time of signing the informed consent form.
Confirmed diagnosis of chronic phase MPN: high risk ET (HU failure/intolerance), low-intermediate 1 (DIPSS 0-1) PMF
Verified mutation in CALR exon 9
PS ≤ 2
Absolute neutrophil count ≥ 1000/mm3
Platelet count ≥ 50,000/mm3
Creatinine ≤ 2.5 mg/dL
Total bilirubin ≤ 2 mg/dL, (except in patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL)
Transaminases 3 times above the upper limits of the institutional normal.
INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator if have not had any episodes of severe hemorrhage.

Patient Q&A Section

Can myeloproliferative disorders be cured?

"For patients with myeloproliferative diseases, the probability of obtaining a complete remission is high enough with currently available treatments to exclude a cure according to traditional definitions of cure in these disorders." - Anonymous Online Contributor

Unverified Answer

What causes myeloproliferative disorders?

"Though a large number of factors are known to cause the disorder, none of them explains all disease cases. Also, it is clear that a large number of myeloproliferative disease cases with genetic aetiology arise from a common background of environmental exposures to other diseases. As a result, a causal interaction exists between the two diseases in the environment-disease interaction model, which suggests that myeloproliferative disorders are caused by factors in the environment. The factors most frequently implicated in the incidence of MPD include exposure to infectious and noninfectious agents through inhalation, ingestion and exposure to drugs or toxins that are associated with MPD as well as genetic and environmental factors." - Anonymous Online Contributor

Unverified Answer

What are common treatments for myeloproliferative disorders?

"The common treatments for myeloproliferative disorders are mainly dependent on the underlying disorders. Drugs such as thalidomide and phlebotomy may be useful in the treatment of primary and secondary myeloproliferative disorders." - Anonymous Online Contributor

Unverified Answer

What are the signs of myeloproliferative disorders?

"Abnormalities in the blood count, bone marrow biopsy and a family history of cancer are the most clinically relevant signs amongst those evaluated in a primary care outpatient setting. These signs correlate with an increase in life expectancy of the patient." - Anonymous Online Contributor

Unverified Answer

What is myeloproliferative disorders?

"Myeloproliferative disorders are conditions like chronic myelogenous leukemia and acute myelogenous leukemia caused by abnormal growth of myeloid stem cells. Chronic myelogenous leukemia and acute myelogenous leukemia are the most common forms of leukemia. The most common form of myeloproliferative disorder is essential thrombocytosis.\n" - Anonymous Online Contributor

Unverified Answer

What is the latest research for myeloproliferative disorders?

"The most recent studies that have been published so far have the potential to give us some very important information regarding the role of the JAK2 V617F mutation in different types of myelodysplasia, which could lead us to consider a "test and treat" strategy, although this issue needs to be investigated further." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of poly iclc?

"[Drugs like poly il clc that are intended to treat specific diseases (such as leprosy and psoriasis) often have adverse side effects ] Drugs may produce any number of side effects when used for a long or irregular period of time or when used at high doses. The side effects of poly il clc may include gastrointestinal disturbances (nausea) or neurological disturbances (mild anxiety, dizziness, headaches, and tiredness), fatigue, itching during use, and the development of skin tags (folliculitis)." - Anonymous Online Contributor

Unverified Answer

Is poly iclc safe for people?

"Despite this study being a retrospective review of the literature, we are limited by the small number of patients we are able to review, with a single center study on a limited number of participants in an international population. Results from a recent clinical trial may be generalizable to other patients. Results from a recent clinical trial should be validated in a prospective multicenter study." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for myeloproliferative disorders?

"All patients with any disorder with a current need for therapy or who are contemplating future therapy should be informed of trial options and the potential risks and benefits of treatment. In addition, patients with multiple myeloma need a comprehensive assessment for therapy options and treatment options during disease progression. Patients with CLL may have multiple treatment options, which should not be ignored." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating myeloproliferative disorders?

"Myeloproliferative disorders, including myeloproliferative neoplasms (MPNs), myeloid malignancies, and myeloproliferative disorders of ambiguous cell lineage (MPDOs), have had a tumultuous and contentious history, characterized at various points by a number of monoclonal antibody-based or small molecule-based target-incorporation approaches to treating and studying the disorder. Recently, however, we have seen an increasing number of new drugs, and more recently novel approaches. In summary, we have had a number of new drugs incorporating new insights in treating the disorder, as well new techniques and new perspectives in looking to study the disease." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of myeloproliferative disorders?

"Many of our patients present with a diagnosis of myelodysplastic syndromes, [polycythemia vera](https://www.withpower.com/clinical-trials/polycythemia-vera), and essential thrombocythemia. These 3 hematological malignancies are classified as myeloproliferative disorders. It is known that these disorders arise from the neoplastic proliferation of myeloid progenitor cells. It remains unclear if these neoplastic cells are self-sustaining or arise in the myeloid compartment via random mutations in the hematopoietic progenitor cells or whether they arise in an activated precursor cell of myeloid origin by a process of transformation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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