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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another active cancer, except for certain types like myelofibrosis, AML, skin cancer that has been removed, and early stage cervical and prostate cancer.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.You have received a type of stem cell transplant called allogeneic hematopoietic stem cell transplantation in the past.You have had allergic reactions to drugs that are similar to ruxolitinib.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ruxolitinib phosphate, chemotherapy,allogeneic HCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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