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Reduced Intensity Conditioning

Stem Cell Transplant for Myelofibrosis

Phase 2

Recruiting

Led By Rachel B. Salit

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meeting criteria for intermediate-1, intermediate-2, or high-risk disease by DIPSS-plus scoring system

Patient must be a potential hematopoietic stem cell transplant candidate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

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.

Who is the study for?

This trial is for adults over 18 with primary or secondary myelofibrosis who may benefit from a stem cell transplant. They should have been on a JAK inhibitor for at least 8 weeks, have good organ function, and not be pregnant or HIV positive. Ideal candidates don't have severe liver disease, uncontrolled infections, or previous allogeneic transplants.Check my eligibility

What is being tested?

The study tests if taking a JAK inhibitor before undergoing reduced intensity haploidentical transplantation can lower graft failure in myelofibrosis patients. It includes pre-treatment with drugs like Cyclophosphamide and Fludarabine followed by stem cell transplantation.See study design

What are the potential side effects?

Potential side effects include reactions to medications such as Cyclophosphamide (nausea, hair loss), Tacrolimus (kidney problems, high blood pressure), and risks associated with stem cell transplantation like infection risk increase and graft-versus-host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is classified as intermediate-1, intermediate-2, or high-risk.

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I am considered a candidate for a stem cell transplant.

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I have been diagnosed with primary or secondary myelofibrosis.

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I am older than 18 years.

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I am able to care for myself but may not be able to do active work.

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My kidneys are functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Probability of primary and secondary graft failure

Secondary outcome measures

Incidence and severity of acute and chronic graft versus host disease (GVHD)

Incidence of relapse

Incidence of severe (grade 3 or 4) cytokine release syndrome

+3 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (JAK inhibitor, conditioning, GVHD prophylaxis)Experimental Treatment16 Interventions

JAK INHIBITOR THERAPY: Patients receive a JAK inhibitor at least 8 weeks prior to the start of HCT conditioning through day -4 before transplantation. CONDITIONING: Patients receive melphalan IV over 1 hour on day -5, fludarabine IV over 30-60 minutes on days -5 to -2, and undergo TBI on day -1 or day -1 and day 0. TRANSPLANT: Patients receive peripheral blood stem cell infusion on day 0. GVHD PROPHYLAXIS: Patients then receive cyclophosphamide IV over 3 hours on days 3-4, tacrolimus IV beginning day 5 then PO for 6 months, mycophenolate mofetil PO BID or TID beginning day 5 for 6 weeks, and G-CSF SC beginning day 7 until neutrophil recovery is > 1,500/mm^3. All patients undergo MRI, CT, bone marrow biopsy and aspiration and blood sample collection throughout the trial. Patients also undergo ECHO or MUGA on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Biospecimen Collection

2004

Completed Phase 2

~1730

Echocardiography

2013

Completed Phase 4

~11670

Cyclophosphamide

1995

Completed Phase 3

~3770

Recombinant Granulocyte Colony-Stimulating Factor

2018

Completed Phase 2

~70

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Tacrolimus

2011

Completed Phase 4

~4740

Melphalan

2008

Completed Phase 3

~1500

Fludarabine

2012

Completed Phase 3

~1100

Total-Body Irradiation

1997

Completed Phase 3

~1180

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,235 Total Patients Enrolled

11 Trials studying Primary Myelofibrosis

603 Patients Enrolled for Primary Myelofibrosis

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,258 Total Patients Enrolled

12 Trials studying Primary Myelofibrosis

633 Patients Enrolled for Primary Myelofibrosis

Rachel B. SalitPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

3 Previous Clinical Trials

152 Total Patients Enrolled

2 Trials studying Primary Myelofibrosis

106 Patients Enrolled for Primary Myelofibrosis

Media Library

Cyclophosphamide (Reduced Intensity Conditioning) Clinical Trial Eligibility Overview. Trial Name: NCT04370301 — Phase 2

Primary Myelofibrosis Research Study Groups: Treatment (JAK inhibitor, conditioning, GVHD prophylaxis)

Primary Myelofibrosis Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04370301 — Phase 2

Cyclophosphamide (Reduced Intensity Conditioning) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04370301 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities for individuals to enroll in this experiment?

"Affirmative. According to clinicaltrials.gov, this research project is accepting participants and was first posted on February 9th 2021 with the latest update occurring November 22nd 2022. The trial intends to enroll 10 patients from 1 site."

Answered by AI

To what diseases or conditions is Peripheral Blood Stem Cell Transplantation typically administered?

"Peripheral Blood Stem Cell Transplantation is typically used to treat dermatitis and atopic conditions, but it also has potential efficacy for multiple sclerosis, leukemia, acute myelocytic lymphoma."

Answered by AI

Has Peripheral Blood Stem Cell Transplantation been evaluated through other research endeavors?

"Currently, 1173 research studies related to Peripheral Blood Stem Cell Transplantation are being conducted worldwide. Of those trials, 212 have reached the Phase 3 stage. Philadelphia, Pennsylvania serves as the epicentre of these investigations; however, 34667 sites around the globe are offering this particular treatment."

Answered by AI

How many participants have signed up for this research undertaking?

"Affirmative, the information accessible on clinicaltrials.gov reveals that this study is presently enrolling individuals. The project was initially posted on February 9th 2021 and updated most recently November 22nd 2022. There are openings for 10 people at a single site."

Answered by AI

Is the FDA providing regulatory approval for Peripheral Blood Stem Cell Transplantation?

"We rated the safety of Peripheral Blood Stem Cell Transplantation at a 2, as it has undergone Phase 2 testing with some evidence for its security but none to verify its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

2021. "Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04370301.

All > Fibrosis > Myelofibrosis