Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia

NCT ID: NCT01960387

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-03-31

Brief Summary

The combination of clofarabine and cytarabine is an effective and reasonably well-tolerated treatment regimen in patients with either relapsed/refractory or newly diagnosed AML. For this prospective study, we propose the use of clofarabine and cytarabine for second course induction therapy for patients with persistent AML after treatment with an anthracycline and cytarabine.

Detailed Description

The primary objective of this prospective study is to evaluate the efficacy (i.e., complete response rate) of clofarabine and cytarabine as second course therapy for the treatment of AML. The secondary objectives are to assess the treatment-related toxicities, to determine the overall and relapse-free survival for patients with AML who are treated with this regimen, and to evaluate potential factors that are predictive of response.

The investigational nature and objective of this study, the procedures involved and their associated risks, potential benefits, and potential alternative therapies will be explained to the patient, and a signed informed consent document will be obtained. Once consented, eligible patients will be treated by the acute leukemia service on the University of Pittsburgh Cancer Institute inpatient unit.

Prior to the start of chemotherapy, patients will receive dexamethasone and ondansetron as pre-medication. Clofarabine will then be administered as intravenous infusion on days 1 through 5. Patients will be monitored closely with vital signs. Cytarabine will then be given as intravenous infusion, starting 3 (maximum of 4) hours after the completion of clofarabine administration on days 1 through 5.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clofarabine and Cytarabine

Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5. Cytarabine at a dose of 1g/m2 daily will then be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.

Group Type: EXPERIMENTAL

Clofarabine

Intervention Type: DRUG

Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5.

Cytarabine

Intervention Type: DRUG

Cytarabine at a dose of 1g/m2 daily will be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.

Interventions

Clofarabine

Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5.

Intervention Type: DRUG

Cytarabine

Cytarabine at a dose of 1g/m2 daily will be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.

Intervention Type: DRUG

Other Intervention Names

Clolar; antimetabolite; Purine nucleoside analog; Cytosine arabinoside; antimetabolite; Pyrimidine analog

Eligibility Criteria

Inclusion Criteria

1. Patients with newly diagnosed AML based on the World Health Organization classification who have persistent disease after their first course treatment with an anthracycline and cytarabine

2. Able to understand and have the ability to provide written informed consent

3. Patients over 18 years of age

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

5. Left ventricular ejection fraction (LVEF) ≥ 50%

6. Negative urine pregnancy test for all females

7. All subjects must agree to use an effective method of contraception while receiving the study drugs

Exclusion Criteria

1. Diagnosis of acute promyelocytic leukemia

2. Relapsed AML

3. Prior use of clofarabine

4. Previous allogeneic or autologous hematopoietic cell transplantation

5. Impaired liver function (serum total bilirubin > 2.0 mg/dL, alanine aminotransferase and aspartate aminotransferase ≥ 4 x the upper limit of normal)

6. Impaired renal function (serum creatinine ≥ 2.0 mg/dL)

7. Uncontrolled or life-threatening infection that is not responding to antimicrobial therapy

8. History of a psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent

9. Concurrent active malignancy; exceptions include patients who have been disease free for 5 years, patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, or patients with another malignancy that is indolent or definitively treated

10. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory or cardiac disease)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Michael Boyiadzis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Boyiadzis, M.D., M.H.Sc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCI 13-066

Identifier Type: -

Identifier Source: org_study_id