Pacritinib Combined With Decitabine or Cytarabine in Older Patients With AML

• Status: Terminated
• Trial end date: 2017-10-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if a medicine called pacritinib is both safe and effective as a study intervention for patients with AML in combination with either decitabine or cytarabine. Pacritinib is an experimental drug that is being studied to treat acute myeloid leukemia (AML). Decitabine and cytarabine are both FDA approved drugs that are used in treatment of AML. Pacritinib is being tested in clinical trials and has not been submitted to the U.S. Food and Drug Administration (FDA) for approval for any indications. Pacritinib is a drug that is designed to slow down the growth of leukemic cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Azacitidine; Cytarabine; Decitabine

Criteria

Inclusion Criteria:

1. Patient has unequivocal pathologic diagnosis of AML (≥ 20% blasts in the bone marrow based on World Health Organization (WHO) criteria), excluding acute promyelocytic leukemia t(15;17)(q22;q12); Promyelocytic leukemia gene (PML)- retinoic acid receptor alpha (RARA)

2. Age ≥ 65 years old

3. No prior treatment for AML except:

• Emergency leukapheresis

• Emergency treatment for hyperleukocytosis with hydroxyurea

• Cranial radiotherapy (RT) for Central Nervous System (CNS) leukostasis (one dose only)

• Growth factor/cytokine support

4. AML patients with therapy-related myeloid neoplasms are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for ≥ 6 months. Hydroxyurea may be used at the investigator's discretion up to the first 28 days on Cycle 1 to maintain WBC <30,000/µl.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

6. Subjects must have adequate hepatic and renal function

7. Female subject of child-bearing potential and male subjects with female partners of reproductive potential must use acceptable contraceptive methods

8. Able to understand and to provide written informed consent

9. Able to comply with all study procedures during the study including all visits and tests

10. Willing to adhere to the prohibitions and restrictions specified in this protocol

11. Patient must sign an informed consent form (ICF)

Exclusion Criteria:

1. Prior treatment with decitabine

2. Prior treatment with cytarabine

3. Prior treatment with pacritinib

4. Presence of serious illness, medical condition, or other medical history, involving the heart, kidney, liver, or other organ system, including abnormal laboratory parameters, which, in the opinion of the Investigator, would be likely to interfere with a subject's participation in the study or with the interpretation of the results.

5. Active, uncontrolled, clinically significant infection(s)

6. Have other active malignancies (excluding other myeloid hematologic malignancies) or other malignancies within 12 months before enrollment, except curatively treated non-melanoma skin cancer, cervical intraepithelial neoplasia, organ-confined or treated non-metastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma

7. Are receiving any other investigational therapy or protocol-prohibited therapy

8. Any prior or co-existing medical condition that in the Investigator's judgment will substantially increase the risk associated with the subject's participation in the study

9. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures

10. Any gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication

11. Inflammatory or chronic functional bowel disorder, such as Crohn's disease, inflammatory bowel disease, chronic diarrhea

12. Clinically symptomatic and uncontrolled cardiovascular disease

13. History of any of the following within 6 months: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure

14. New York Heart Association Class III or IV congestive heart failure

15. Patients with National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) grade 2 cardiac arrhythmias may be considered for inclusion with the approval of the investigator if the arrhythmias are stable, asymptomatic and unlikely to affect patient safety. Patients will be excluded if they have ongoing cardiac dysrhythmias of CTCAE grade 3, corrected QT interval (QTc) prolongation >450 ms by Fridericia method, or other factors that increase the risk for QT prolongation (eg, heart failure, hypokalemia [defined as serum potassium < 3.0 milliequivalent (mEq/L) that is persistent and refractory to correction], or family history of long QT interval syndrome).