Peripheral Blood Stem Cell Transplantation for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Primary Myelofibrosis+1 MorePeripheral Blood Stem Cell Transplantation - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical transplantation for the treatment of primary or secondary myelofibrosis.

Eligible Conditions
  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 3 years

1 year
NRM
3 years
Overall survival
At 1 year
Incidence of relapse
Day 100
Non-relapse mortality (NRM)
Up to 3 years
Incidence and severity of acute and chronic graft versus host disease (GVHD)
Incidence of severe (grade 3 or 4) cytokine release syndrome
Probability of primary and secondary graft failure

Trial Safety

Safety Progress

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

Side Effects for

Arm II (TBI, Transplant, GVHD Prophylaxis)
23%Blood/Bone marrow
11%Cardiovascular
9%Pulmonary
7%Hepatic
7%Gastrointestinal
5%Graft versus host disease with infection and organ failure
2%respiratory failure
2%Hemorrhage
2%subdural hematoma
2%thrombosis
2%Dermatology/Skin
2%Renal/Genitourinary
2%Metabolic/Laboratory
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT00075478) in the Arm II (TBI, Transplant, GVHD Prophylaxis) ARM group. Side effects include: Blood/Bone marrow with 23%, Cardiovascular with 11%, Pulmonary with 9%, Hepatic with 7%, Gastrointestinal with 7%.

Trial Design

1 Treatment Group

Treatment (JAK inhibitor, conditioning, GVHD prophylaxis)
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

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

Treatment (JAK inhibitor, conditioning, GVHD prophylaxis)Experimental Group · 9 Interventions: Cyclophosphamide, Recombinant Granulocyte Colony-Stimulating Factor, Mycophenolate Mofetil, Peripheral Blood Stem Cell Transplantation, Tacrolimus, JAK Inhibitor, Melphalan, Fludarabine, Total-Body Irradiation · Intervention Types: Drug, Biological, Drug, Procedure, Drug, Drug, Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Mycophenolate mofetil
FDA approved
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1360
Tacrolimus
FDA approved
Mechlorethamine
FDA approved
Fludarabine
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
530 Previous Clinical Trials
1,303,717 Total Patients Enrolled
12 Trials studying Primary Myelofibrosis
671 Patients Enrolled for Primary Myelofibrosis
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,041 Total Patients Enrolled
11 Trials studying Primary Myelofibrosis
641 Patients Enrolled for Primary Myelofibrosis
Rachel B. SalitPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
190 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
144 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.
You are able to understand the nature and significance of the study and the risks and benefits of participating in the study.
Creatinine clearance must be > 60 ml/min.