Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia

NCT01960387 | Terminated Phase 2 Results DMC

• 1 other identifier: UPCI 13-066
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML; clofarabine; cytarabine; persistent AML; induction therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Between 14 and 28 days from start of study treatment

Secondary Outcomes (3)

• Overall Survival

  Up to 24 months

• Relapse Free Survival

  Up to 24 months

• Predictive Factors for Response to Treatment.

  Up to 1 year

Study Arms (1)

Clofarabine and Cytarabine

EXPERIMENTAL

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.

Drug: Clofarabine; Drug: Cytarabine

Interventions

Clofarabine 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.

Also known as: Clolar, antimetabolite, Purine nucleoside analog

Clofarabine and Cytarabine

Cytarabine 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.

Also known as: Cytosine arabinoside, antimetabolite, Pyrimidine analog

Clofarabine and Cytarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Clofarabine; Antimetabolites; Purine Nucleosides; Cytarabine; pyrimidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Results data is not available for Overall Survival, Relapse-free Survival, or assessment of potential predictive factors for response to treatment, due to early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Michael Boyiadzis, MD
• Organization: University of Pittsburgh Cancer Institute

boyiadzism@upmc.edu

412-623-0040

Study Officials

• Michael Boyiadzis, M.D., M.H.Sc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 2, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-06

Locations

US (1)