Peripheral Blood Stem Cell Transplantation for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CA
Primary Myelofibrosis+13 More
Peripheral Blood Stem Cell Transplantation - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This clinical trial evaluates the safety and effectiveness of adding itacitinib to cyclophosphamide and tacrolimus for the prevention of graft versus host disease (GVHD) in patients undergoing hematopoietic stem cell transplant. Itacitinib is an enzyme inhibitor that may regulate the development, proliferation, and activation of immune cells important for GVHD development. Cyclophosphamide and tacrolimus are immunosuppressive agents that may prevent GVHD in patients who receive stem cell transplants. Giving itacitinib in addition to cyclophosphamide and tacrolimus may be more effective at preventing GVHD in patients receiving hematopoietic stem cell transplants.

Eligible Conditions

  • Primary Myelofibrosis
  • Muscular Dystrophy
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelocytic, Acute
  • Myeloproliferative Neoplasms (MPNs)
  • Acute Lymphoblastic Leukemia (ALL)
  • Secondary Myelofibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Primary Myelofibrosis

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Up to 2 years

By day 100
Grade III-IV acute graft versus host disease (GVHD)
Number of participants with Grade III-IV acute graft versus host disease (GVHD)
Day 120
Rate of infection
Year 1
Relapse/progression
Year 1
Non-relapse mortality
Year 1
Overall survival
Year 1
Rate of chronic GVHD
Year 1
GVHD-free relapse-free survival rate
Year 1
Progression free survival
On day 100
Rate of acute GVHD
Up to 2 years
Gut microbiome assessment
Incidence of adverse events
Incidence of cytokine release syndrome
Rate of hematologic recovery

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Primary Myelofibrosis

Trial Design

1 Treatment Group

Prevention (PBSCs, cyclophosphamide, itacitinib, tacrolimus)
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Peripheral Blood Stem Cell Transplantation · No Placebo Group · Phase 2

Prevention (PBSCs, cyclophosphamide, itacitinib, tacrolimus)Experimental Group · 5 Interventions: Tacrolimus, Itacitinib, Quality-of-Life Assessment, Cyclophosphamide, Peripheral Blood Stem Cell Transplantation · Intervention Types: Drug, Drug, Other, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2011
Completed Phase 4
~4510
Itacitinib
2018
Completed Phase 3
~790
Cyclophosphamide
1995
Completed Phase 3
~4020
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1970

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: City of Hope Medical Center · Duarte, CA
Photo of Duarte 1Photo of Duarte 2Photo of Duarte 3
2002First Recorded Clinical Trial
6 TrialsResearching Primary Myelofibrosis
142 CompletedClinical Trials

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
501 Previous Clinical Trials
2,246,345 Total Patients Enrolled
8 Trials studying Primary Myelofibrosis
315 Patients Enrolled for Primary Myelofibrosis
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,410 Total Patients Enrolled
68 Trials studying Primary Myelofibrosis
6,686 Patients Enrolled for Primary Myelofibrosis
Monzr M Al MalkiPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
130 Total Patients Enrolled
1 Trials studying Primary Myelofibrosis
16 Patients Enrolled for Primary Myelofibrosis

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a Karnofsky performance status of 70% or higher.
You have provided informed consent of the participant and/or legally authorized representative.
If available, exceptions may be granted with study principal investigator (PI) approval.
You are 80 years of age or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.