Total-Body Irradiation for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Primary Myelofibrosis+1 MoreTotal-Body Irradiation - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a drug can help prevent a condition where the transplanted cells from a donor can attack the body's normal cells and improve transplant outcomes in patients with primary and secondary myelofibrosis.

Eligible Conditions
  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: At 1 and 2 years

6 months
Incidence of primary and secondary graft failure
Year 2
Overall survival rate (OS)
At 1 year
Incidence of relapse
Day 100
Time to neutrophil (ANC > 500) engraftment
Time to platelet (> 20,000) engraftment
Year 1
Non-relapse mortality (NRM)
Up 2 years
Incidence of chronic GVHD
Up to day 100
Incidence of grade II-IV graft versus host disease (GVHD) in myelofibrosis patients
Incidence of grade III-IV GVHD

Trial Safety

Safety Progress

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

Trial Design

1 Treatment Group

Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Total-Body Irradiation · No Placebo Group · Phase 2

Treatment (ruxolitinib, conditioning, HSCT, GVHD prophylaxis)Experimental Group · 10 Interventions: Ruxolitinib, Tacrolimus, Cyclophosphamide, Total-Body Irradiation, Allogeneic Hematopoietic Stem Cell Transplantation, Fludarabine, Busulfan, Melphalan, Methotrexate, Mycophenolate Mofetil · Intervention Types: Drug, Drug, Drug, Radiation, Procedure, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved
Tacrolimus
FDA approved
Cyclophosphamide
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1220
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1280
Fludarabine
FDA approved
Busulfan
FDA approved
Mechlorethamine
FDA approved
Methotrexate
FDA approved
Mycophenolate mofetil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 and 2 years

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,096 Total Patients Enrolled
11 Trials studying Primary Myelofibrosis
606 Patients Enrolled for Primary Myelofibrosis
Fred Hutchinson Cancer CenterLead Sponsor
531 Previous Clinical Trials
1,313,772 Total Patients Enrolled
12 Trials studying Primary Myelofibrosis
636 Patients Enrolled for Primary Myelofibrosis
Rachel B. SalitPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
155 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
109 Patients Enrolled for Primary Myelofibrosis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a potential hematopoietic stem cell transplant candidate as assessed by the consenting physician.
You are able to understand the nature and purpose of the study and the potential risks and benefits of participating in the study.
Allogeneic stem cell transplantation is a form of immunosuppression.