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Study of Ruxolitinib Plus Decitabine in Patients With Acute Myeloid Leukemia (AML)

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Myeloproliferative Diseases

Intervention: Ruxolitinib (Drug); Decitabine (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Farhad Ravandi-Kashani, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Farhad Ravandi-Kashani, MD, Phone: 713-745-0394

Summary

This clinical research study is made up of 2 parts: Phase 1 and Phase 2. The goal of Phase 1 of this study is to find the highest tolerable dose of the combination of decitabine and ruxolitinib that can be given to patients with AML. The goal of Phase 2 of this study is to learn if decitabine and ruxolitinib can help to control a certain kind of AML called post myeloproliferative neoplasm AML (post MPN-AML). The safety of the drug combination will be studied in both phases.

Clinical Details

Official title: Phase I/II Study of Ruxolitinib Plus Decitabine in Patients With Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia (AML)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of Ruxolitinib Plus Decitabine

Secondary outcome: Overall Response

Detailed description: Study Phases and Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of up to 6 participants will be enrolled in Phase 1 of the study, and up to 24 participants will be enrolled in Phase 2. If you are enrolled in Phase 1, the dose of ruxolitinib you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of ruxolitinib. If no intolerable side effects are seen, a second group of participants will receive a higher dose of ruxolitinib. If intolerable side effects are seen in the first group, up to 2 more groups will be enrolled and will receive lower doses than the first group. If you are enrolled in Phase 2, you will receive ruxolitinib at the highest dose that was tolerated in Phase 1. All participants in both phases will receive the same dose level of decitabine. Study Drug Administration: Each study cycle is 28 days. They may be longer, if needed for you to recover from receiving the drugs. You will take ruxolitinib by mouth 2 times every day (about 12 hours between each dose). You can take the drug with or without food, but you need to take it with about 1 cup (8 ounces) of water. If you forget to take a scheduled dose, you should take the study drug within 3 hours after the missed dose. If more than 3 hours have passed since your missed dose, then you should wait to take the study drug until your next scheduled dose. On Days 1-5 of each cycle, you will receive decitabine by vein over about 1-2 hours. Study Visits: At least 1 time every week during Cycle 1, then at least 1 time every 2 weeks during all cycles after that:

- You will have a physical exam.

- Blood (about 6 teaspoons) will be drawn for routine tests.

If the doctor thinks is it needed, at the end of each cycle:

- You will have a bone marrow aspirate/biopsy to check the status of the disease, for

cytogenetic testing, and genetic testing. If the doctor thinks it is needed, extra blood (about 3 tablespoons) will be drawn for these tests.

- You will have a CT or MRI of the abdomen/pelvis to check the status of the disease.

Research Blood Tests: Blood (about 2 tablespoons) will be drawn to check for substances in the blood that may be affected by the study drug and which may also predict response to the study drug. This blood sample will be drawn before you receive the study drugs, after Cycles 1 and 3, and then every 3 cycles after that. This will also be drawn after you stop taking the study drugs. Length of Study: You may continue taking the study drugs for up to 24 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. End of Study Visit: When your active treatment on this study has ended (for any reason), you will asked to return to the clinic for an End of Study visit. The following tests and assessments will be performed:

- You will have a physical exam.

- Blood (about 6 teaspoons) will be collected for routine tests.

- You will have an EKG.

- You will have a bone marrow aspirate/biopsy to check the status of the disease, for

cytogenetic testing, and genetic testing. If the doctor thinks it is needed, extra blood will be drawn for these tests.

- Blood (about 3 tablespoons) will be drawn to check the status of the disease.

This is an investigational study. Ruxolitinib is FDA approved and commercially available for the treatment of patients with intermediate or high-risk myelofibrosis. Decitabine is FDA approved and commercially available for the treatment of patients with several different types of myeloid diseases such as myelodysplastic syndromes (MDS). It is investigational to give these drugs in combination with each other to patients with AML. Up to 42 participants will be enrolled in this multicenter study. All will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Diagnosis of AML (WHO classification definition of > or = to 20% blasts) 2. In the phase I portion of the study all patients with relapsed or refractory AML are eligible. For the Phase II portion of the study, patients must have AML progressing from prior MPN (MPN-BP) or have MDS/MPN with more than 20% blasts. Temporary prior measures to control blood counts, such as apheresis or hydrea are allowed. Patients with newly diagnosed or previously treated disease are eligible as long as prior therapy does not include hypomethylating agents. Prior therapy for RUXOLITINIB for MPN is allowed. 3. Serum biochemical values with the following limits unless considered due to leukemia:

- -- Creatinine < or= to 1. 5mg/dl ---- total bilirubin < or = to 1. 5 mg/dL, unless

increase is due to hemolysis or congenital disorder - --- transaminases (SG PT) < or =

to 2. 5x ULN 4. Ability to take oral medication. 5. Ability to understand and provide signed informed consent. 6. Performance status < or = to 3, unless directly related to disease process as determined by the Principal Investigator. 7. Age > or = 18 years Exclusion Criteria: 1. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results including uncontrolled severe infections, as well as uncontrolled cardiac disease, or other organ dysfunction. Patients with history of tuberculosis, HIV or hepatitis B and C are excluded. 2. Nursing women, women of childbearing potential with positive blood pregnancy test within 30 days of study start, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study. 3. Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access. 4. Active clinically serious and uncontrolled infection.

Locations and Contacts

Farhad Ravandi-Kashani, MD, Phone: 713-745-0394

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: February 2015
Last updated: July 20, 2015

Page last updated: August 23, 2015

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