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Alkylating Agent

Ruxolitinib + Chemotherapy + Stem Cell Transplant for Myelofibrosis

Phase 1
Waitlist Available
Led By Haris Ali
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior therapy with hydroxyurea, interferon, anagrelide, ruxolitinib, hypomethylating agents, revlimid, thalidomide, steroids, other JAK inhibitors is allowed; for acute myeloid leukemia (AML) patients who are back in chronic phase myeloproliferative neoplasm (MPN), prior induction therapy is allowed
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a drug when given with chemotherapy before and after a stem cell transplant to treat patients with cancer of the bone marrow.

Eligible Conditions
  • Primary Myelofibrosis
  • Myelofibrosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been treated with certain medications like hydroxyurea, interferon, anagrelide, ruxolitinib, hypomethylating agents, revlimid, thalidomide, steroids, or other JAK inhibitors before. If you have acute myeloid leukemia (AML) and have returned to the chronic phase of myeloproliferative neoplasm (MPN), prior induction therapy is also allowed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Maximum tolerated dose of ruxolitinib phosphate, defined as less than or equal to 1 of 6 dose limiting toxicities, graded according to the Bearman criteria and the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Secondary outcome measures
Cumulative incidence of acute graft-versus-host disease (aGVHD), graded and staged according to the Consensus Grading
Graft-vs-Host Disease
Cumulative incidence of relapse/progression
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ruxolitinib phosphate, chemotherapy,allogeneic HCT)Experimental Treatment10 Interventions
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV on days -9 to -5, melphalan IV over 20 minutes on day -4, and ruxolitinib phosphate PO BID on days -3 to 30 with a taper for 2-3 weeks in the absence of disease progression or unacceptable toxicity. Patients being treated with ruxolitinib phosphate prior to allogeneic HCT as standard therapy may continue receiving ruxolitinib phosphate. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously beginning on day -3 and convert to PO daily when the patient is able to tolerate and absorb oral medications. Patients also receive sirolimus PO daily beginning on day -3. Treatment continues in the absence of GVHD. STEM CELL TRANSPLANT: Patients undergo allogeneic HCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Fludarabine
2012
Completed Phase 3
~1090
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Melphalan
2008
Completed Phase 3
~1500
Ruxolitinib
2018
Completed Phase 3
~1140
Ruxolitinib Phosphate
2011
Completed Phase 2
~390
Sirolimus
2013
Completed Phase 4
~2750
Tacrolimus
2011
Completed Phase 4
~4740

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,433 Total Patients Enrolled
8 Trials studying Primary Myelofibrosis
347 Patients Enrolled for Primary Myelofibrosis
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,257 Total Patients Enrolled
69 Trials studying Primary Myelofibrosis
6,823 Patients Enrolled for Primary Myelofibrosis
Haris AliPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
59 Patients Enrolled for Primary Myelofibrosis

Media Library

Fludarabine Phosphate (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02917096 — Phase 1
Primary Myelofibrosis Research Study Groups: Treatment (ruxolitinib phosphate, chemotherapy,allogeneic HCT)
Primary Myelofibrosis Clinical Trial 2023: Fludarabine Phosphate Highlights & Side Effects. Trial Name: NCT02917096 — Phase 1
Fludarabine Phosphate (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02917096 — Phase 1

Frequently Asked Questions

~2 spots leftby Mar 2025