Ruxolitinib + Allogeneic Stem Cell Transplantation in AML

Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:60 - 80
Start Date:November 3, 2017
End Date:September 1, 2024
Contact:Gabriella Hobbs, MD

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Phase II Study of Maintenance Ruxolitinib After Allogeneic Stem Cell Transplantation for Older Patients With Acute Myeloid Leukemia (AML) in First Complete Remission (CR1)

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:

• Ruxolitinib

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.

Inclusion Criteria:

- Participants must have pathologically confirmed AML in CR1 as defined by:

- Bone marrow biopsy with < 5% blasts

- No clusters or collections of blast cells

- No extramedullary leukemia

- Absolute neutrophil count ≥ 1000/µL (achieved post-induction at some point)

- Please note that full platelet recovery is not necessary, and thus, patients
achieving CRp are eligible.

- Participants must be designated to undergo reduced intensity allogeneic peripheral
blood hematopoietic stem cell transplantation (HCT). Consent will be obtained prior to
admission for HCT. The following HCT conditions must be planned:

- Donors must be 8/8 HLA-matched (at the allele level) as defined by matching at
HLA-A, -B, -DR and -C who pass institutional standard to serve as a peripheral
blood stem cell donor

- Donor grafts must be G-CSF mobilized peripheral blood stem cells with dose and
apheresis logistics at the discretion of institutional standard

- Conditioning therapy will be one of the following 3 options:

- Fludarabine / Melphalan where fludarabine is ≥ 90 mg/m2 IV total dose and
melphalan is 100-140 mg/m2 IV total dose. Exact logistics of administration
are at the discretion of institutional standard.

- Fludarabine / Busulfan where fludarabine is ≥ 90 mg/m2 IV total dose and
busulfan = 6.4 mg/kg IV total dose. Exact logistics of administration are at
the discretion of institutional standard.

- Fludarabine / Busulfan where fludarabine is ≥ 90 mg/m2 IV total dose and
busulfan is dosed to achieve AUC of 4000 µmol/min based on a
pharmacokinetics determined from a test dose. Exact logistics are at the
discretion of institutional standard.

- 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.

- Age ≥ 60 and ≤ 80 years old

- ECOG performance status 0-2

- Male participants must agree to use an acceptable method for contraception during the
entire study treatment period and through 6 months after the last dose of treatment.

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Have had a prior allogeneic HSCT.

- Patients without normal organ function defined as follows:

- Platelet count of ≤50,000/ μL, hemoglobin of ≤8g/dL, or ANC of ≤1000 AST (SGOT),
ALT (SGPT) and Alkaline Phosphatase ≥5 × institutional Upper Limit of Normal

- Direct bilirubin >2.0 mg/dL

- Adequate renal function as defined by calculated creatinine clearance ≤ 40 mL/min
(Cockcroft-Gault formula)

- Have a history of other malignancy(ies) unless:

- They have been disease-free for at least 5 years and are deemed by the treating
investigator to be at low risk for recurrence of that malignancy,

--- or

- The only cancer they have had is cervical cancer in situ, or basal cell or
squamous cell carcinoma of the skin

- Have a chronic or active infection that requires systemic antibiotics, antifungal or
antiviral treatment.

- Have current or a history of congestive heart failure New York Heart Association
(NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction
(LVEF < 40%, as measured by MUGA scan or echocardiogram)

- Have an uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

- Be HIV-positive and on combination antiretroviral therapy because of the potential for
pharmacokinetic interactions with ruxolitinib. In addition, these participants are at
increased risk of lethal infections when treated with marrow-suppressive therapy.

- Have a systemic infection requiring IV antibiotic therapy, nor any other severe

- Planned use of ex vivo or in vivo T-cell depletion

- Have current or a history of ventricular or life-threatening arrhythmias or diagnosis
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185 Cambridge Street
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