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Ruxolitinib + Stem Cell Transplant for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Gabriell Hobbs, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have pathologically confirmed AML in CR1 with specific criteria
Participants must have pathologically confirmed MDS with specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death, approximately 5 years
Awards & highlights

Study Summary

This trial is studying ruxolitinib to see how well it works in preventing relapse in people with acute myeloid leukemia who have undergone allogeneic stem cell transplantation.

Who is the study for?
This trial is for adults aged 60-80 with Acute Myeloid Leukemia (AML) in remission, or Myelodysplastic Syndromes (MDS), who are about to receive a stem cell transplant from a fully matched donor. Participants must be healthy enough for the procedure and not have other cancers (except certain skin cancers or cervical cancer in situ), severe infections, significant heart disease, HIV, or previous allogeneic HSCT.Check my eligibility
What is being tested?
The study tests Ruxolitinib's effectiveness in reducing relapse risk after Allogeneic Stem Cell transplantation for AML. Patients will undergo reduced intensity conditioning therapy before receiving stem cells from an HLA-matched donor and will take Ruxolitinib alongside standard graft-versus-host disease prevention.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as blood count changes leading to increased infection risk, bleeding problems, liver function abnormalities, kidney issues and could potentially worsen any current infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML is in the first complete remission.
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My MDS diagnosis is confirmed through lab tests.
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I am set to receive a specific type of stem cell transplant from a donor.
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I am between 60 and 80 years old.
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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death, approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death, approximately 5 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
1-year GVHD/relapse free survival rate (GRFS rate)
Secondary outcome measures
Cumulative incidence of drug related toxicities
Overall Survival
Progression Free Survival
+2 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036
23%
Pruritus
12%
Headache
9%
Diarrhoea
9%
Upper respiratory tract infection
8%
Fatigue
8%
Asthenia
8%
Thrombocytopenia
7%
Nausea
7%
Dizziness
7%
Night sweats
7%
Haematocrit increased
5%
Influenza
5%
Weight decreased
5%
Erythema
5%
Decreased appetite
5%
Leukocytosis
5%
Constipation
4%
Thrombocytosis
4%
Abdominal pain upper
4%
Arthralgia
4%
Hypertension
3%
Pain in extremity
3%
Oedema peripheral
3%
Dyspnoea
3%
Epistaxis
3%
Bronchitis
3%
Abdominal discomfort
3%
Tinnitus
3%
Nasopharyngitis
3%
Myalgia
3%
Dyspepsia
3%
Cough
1%
Anaemia
1%
Vertigo
1%
Depression
1%
Weight increased
1%
Haematoma
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Abdominal pain
1%
Neutropenia
1%
Muscle spasms
1%
Rectal haemorrhage
1%
Cellulitis
1%
Meningitis
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Acute myeloid leukaemia
1%
Bladder transitional cell carcinoma
1%
Breast cancer
1%
Myelofibrosis
1%
Extremity necrosis
1%
Abdominal distension
1%
Flatulence
1%
Vomiting
1%
Pyrexia
1%
Blood lactate dehydrogenase increased
1%
Gamma-glutamyltransferase increased
1%
Hyperuricaemia
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Cardiac failure
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
All Crossover Patients
Ruxolitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityOTHER
703 Previous Clinical Trials
6,142,905 Total Patients Enrolled
Ohio State UniversityOTHER
823 Previous Clinical Trials
501,179 Total Patients Enrolled
Medical College of WisconsinOTHER
608 Previous Clinical Trials
1,162,433 Total Patients Enrolled

Media Library

Ruxolitinib Clinical Trial Eligibility Overview. Trial Name: NCT03286530 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Ruxolitinib
Acute Myeloid Leukemia Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT03286530 — Phase 2
Ruxolitinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03286530 — Phase 2

Frequently Asked Questions

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

Does this experiment have an age limit?

"The target recruitment pool for this trial are patients that fall in the age range of 60 to 80 years old."

Answered by AI

How many people can join this experiment at most?

"That is correct. The information available on clinicaltrials.gov confirms that the study is still recruiting participants. This particular trial was posted on November 3rd, 2017 and was last updated October 21st, 2020. They are looking for a total of 64 individuals who will be spread out among 6 different locations."

Answered by AI

Does Ruxolitinib have any potentially harmful side effects?

"While there is some clinical data supporting the safety of Ruxolitinib, as this is a Phase 2 trial, there is currently no evidence to suggest that it is an effective medication."

Answered by AI

Is this study currently looking for participants?

"This clinical trial is actively recruiting participants, as indicated on the clinicaltrials.gov website. The trial was first posted on November 3, 2017 and was last updated on October 21, 2020."

Answered by AI

Can you tell me some of the most common reasons why patients are prescribed Ruxolitinib?

"Ruxolitinib is frequently prescribed to patients with polycythemia vera. However, it can also be an effective treatment for hydroxyurea-resistant or intolerant polycythemia and primary myelofibrosis."

Answered by AI

Is this study taking place across a broad geographical area in the US?

"Beth Israel Deaconess Medical Center in Boston, Washington University in Saint Louis, and the Medical College of Wisconsin are a few notable locations conducting this clinical trial. 6 other research sites are also participating."

Answered by AI

What do we already know about Ruxolitinib from other research?

"Ruxolitinib was first studied in the year 2002 at National Institutes of Health Clinical Center, 9000 Rockville Pike. 92 clinical trials have been completed since then. Right now, there are 99 ongoing studies with a large number taking place in Boston, Massachusetts."

Answered by AI

How can I sign up to be a part of this clinical trial?

"This trial is for patients aged 60 to 80 with leukemia or myeloid. To be eligible, the following must apply: No extramedullary leukemia, GVHD prophylaxis is comprised of tacrolimus / short course methotrexate as defined by tacrolimus started prior to day 0 of HCT and methotrexate given after HCT on days +1, +3 and +6 ± +11 at a dose of 5-10 mg/m2 IV. Exact logistics are at the discretion of the treating institution., Donors must be 8/8 HLA-matched ("

Answered by AI
~6 spots leftby Dec 2024