Back to resultsPhase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia (UPCI 13-066)
Primary Purpose
Acute Myeloid Leukemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clofarabine
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, clofarabine, cytarabine, persistent AML, induction therapy
Eligibility Criteria
Inclusion Criteria:
- 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
- Able to understand and have the ability to provide written informed consent
- Patients over 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Negative urine pregnancy test for all females
- All subjects must agree to use an effective method of contraception while receiving the study drugs
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia
- Relapsed AML
- Prior use of clofarabine
- Previous allogeneic or autologous hematopoietic cell transplantation
- Impaired liver function (serum total bilirubin > 2.0 mg/dL, alanine aminotransferase and aspartate aminotransferase ≥ 4 x the upper limit of normal)
- Impaired renal function (serum creatinine ≥ 2.0 mg/dL)
- Uncontrolled or life-threatening infection that is not responding to antimicrobial therapy
- History of a psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
- 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
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory or cardiac disease)
Sites / Locations
- UPMC Hillman Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clofarabine and Cytarabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Complete Clinical Response
Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10^9/l, a platelet count greater than or equal to 100 x 10^9/l, and no evidence of extramedullary disease.
Secondary Outcome Measures
Overall Survival
Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).
Relapse Free Survival
Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).
Predictive Factors for Response to Treatment.
Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).
Full Information
NCT ID
NCT01960387
First Posted
October 7, 2013
Last Updated
June 21, 2016
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01960387
Brief Title
Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
Acronym
UPCI 13-066
Official Title
A Phase II Study of Clofarabine and Cytarabine for Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Persistent Disease After Treatment With an Anthracycline and Cytarabine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of accrual
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, clofarabine, cytarabine, persistent AML, induction therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clofarabine and Cytarabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clofarabine
Other Intervention Name(s)
Clolar, antimetabolite, Purine nucleoside analog
Intervention Description
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
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Cytosine arabinoside, antimetabolite, Pyrimidine analog
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Clinical Response
Description
Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10^9/l, a platelet count greater than or equal to 100 x 10^9/l, and no evidence of extramedullary disease.
Time Frame
Between 14 and 28 days from start of study treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).
Time Frame
Up to 24 months
Title
Relapse Free Survival
Description
Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).
Time Frame
Up to 24 months
Title
Predictive Factors for Response to Treatment.
Description
Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Able to understand and have the ability to provide written informed consent
Patients over 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Left ventricular ejection fraction (LVEF) ≥ 50%
Negative urine pregnancy test for all females
All subjects must agree to use an effective method of contraception while receiving the study drugs
Exclusion Criteria:
Diagnosis of acute promyelocytic leukemia
Relapsed AML
Prior use of clofarabine
Previous allogeneic or autologous hematopoietic cell transplantation
Impaired liver function (serum total bilirubin > 2.0 mg/dL, alanine aminotransferase and aspartate aminotransferase ≥ 4 x the upper limit of normal)
Impaired renal function (serum creatinine ≥ 2.0 mg/dL)
Uncontrolled or life-threatening infection that is not responding to antimicrobial therapy
History of a psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
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
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory or cardiac disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Boyiadzis, M.D., M.H.Sc
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia
We'll reach out to this number within 24 hrs