Ruxolitinib + Allogeneic Stem Cell Transplantation in AML
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|ClinicalTrials.gov Identifier: NCT03286530|
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : September 7, 2020
This research study is studying a drug that may help decrease the chances of relapse after Allogeneic Stem Cell transplantation for Acute Myeloid Leukemia. The name of the study drug involved in this study is:
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Acute Myeloid Leukemia in Remission Allogeneic Stem Cell Transplantation||Drug: Ruxolitinib||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved ruxolitinib for this specific disease but it has been approved for other blood diseases.
In this research study, investigators are trying to discover if ruxolitinib will decrease chances of relapse after having an allogeneic stem cell transplantation.
Ruxolitinib is a medication that blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. Many cancers have over active "cell signaling." What this means is that certain functions in the cancer cells never turn off and this makes them grow in an uncontrolled way. Ruxolitinib, shuts down the pathway that depends on the JAK2 tyrosine kinases. The JAK2 pathway is over active with acute myeloid leukemia. Ruxolitinib has also been shown to lower the rates of graft versus host disease, a complication of transplant. The exact way ruxolitinib does this is not yet clear but it may have to do with its ability to block the JAK2 pathway since this pathway can also lead to inflammation in the body.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Maintenance Ruxolitinib After Allogeneic Stem Cell Transplantation for Older Patients With Acute Myeloid Leukemia (AML) in First Complete Remission (CR1)|
|Actual Study Start Date :||November 3, 2017|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||September 1, 2024|
Following a standard of care allogeneic stem cell transplantation, participants will be started on Ruxolitinib. Ruxolitinib is administered orally 2 times per day at a fixed dose. Each study treatment cycle lasts 28 days. Up to 24 cycles.
Patients who fulfill eligibility criteria will be entered into the trial to receive Ruxolitinib.
After the screening procedures confirm participation in the research study. The participant will be given a drug diary. The participant will be asked to document information in the drug diary about the study treatment.
Other Name: Jakafi
- 1-year GVHD/relapse free survival rate (GRFS rate) [ Time Frame: 1 Year ]The number of participants surviving after one year that have not experienced graft-versus-host disease (GVHD) or graft relapse (GRFS rate).
- Progression Free Survival [ Time Frame: Until disease progression or death from any cause, approximately 5 years ]Kaplan-Meier estimates of progression free survival (PFS) will be calculated, with patients without an event being censored at last date of contact
- Overall Survival [ Time Frame: Until death, approximately 5 years ]Overall survival is measured as the time from the hematopoietic stem cell transplantation (HSCT) until death. Participants without an event will be censored at the date of last contact.
- Cumulative incidence of drug related toxicities [ Time Frame: 2 Years ]Cumulative incidence of treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4). Early deaths from all other causes are considered a competing risk.
- Time to Relapse [ Time Frame: 2 Years ]The amount of time from the hematopoietic stem cell transplantation (HSCT) until disease relapse. Relapse is the recurrence of cancer after having a bone marrow biopsy without evidence of cancer. Time to treatment-related mortality is considered a competing risk.
- Time to treatment-related mortality (TRM) [ Time Frame: 2 Years ]The amount of time between receiving the HSCT and death due to a treatment related cause. Time to relapse is considered a competing risk.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286530
|Contact: Gabriella Hobbs, MD||617-726-8747||Ghobbs@mgh.harvard.edu|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Myrna Nahas, MD 617-667-9920|
|Principal Investigator: Myrna Nahas, MD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Gabriella Hobbs, MD 617-726-8748|
|Principal Investigator: Gabriella Hobbs, MD|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|Contact: Mark Schroeder, MD firstname.lastname@example.org|
|Principal Investigator: Mark Schroeder, MD|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Sumithira Vasu, MBBS Sumithira.Vasu@osumc.edu|
|Principal Investigator: Sumithira Vasu, MBBS|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37235|
|Contact: Michael Byrne, MD Michael.Byrne@vanderbilt.edu|
|Principal Investigator: Michael Byrne, MD|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Wauwatosa, Wisconsin, United States, 53226|
|Contact: Sameem Abedin, MD email@example.com|
|Principal Investigator: Sameem Abedin, MD|
|Principal Investigator:||Gabriell Hobbs, MD||Massachusetts General Hospital|