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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

Must not have

Chronic or active infection requiring systemic treatment

History of congestive heart failure or documented cardiac dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until death, approximately 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication for a long-term or active infection.

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I have a history of heart failure or known heart problems.

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I am planning to undergo a treatment that reduces T-cells.

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I have had serious heart rhythm problems.

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I am HIV-positive.

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I currently have an infection that isn't under control.

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I have had a stem cell transplant from a donor.

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I am currently on IV antibiotics for an infection.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until death, approximately 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

1-year GVHD/relapse free survival rate (GRFS rate)

Secondary study objectives

Cumulative incidence of drug related toxicities

Overall Survival

Progression Free Survival

+2 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

Anaemia

19%

Hypertension

17%

Nasopharyngitis

16%

Weight increased

14%

Herpes zoster

14%

Constipation

14%

Abdominal pain

14%

Headache

12%

Pruritus

12%

Back pain

12%

Epistaxis

12%

Pyrexia

12%

Dizziness

10%

Asthenia

10%

Fatigue

10%

Cough

10%

Oedema peripheral

10%

Arthralgia

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Peripheral artery thrombosis

Vertigo

Acute pulmonary oedema

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

0 / 14Eligibility criteria met