Completed

A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies

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What is being tested

cytarabine

+ triapine

+ laboratory biomarker analysis

DrugOther
Who is being recruted

Blast Crisis+23

+ Bone Marrow Diseases

+ Cell Transformation, Neoplastic

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of 3-AP (Triapine) administered with high-dose cytarabine in patients with advanced hematologic malignancies. SECONDARY OBJECTIVES: I. Determine the clinical activity of this regimen in these patients. II. Determine the effect of treatment with 3-AP (Triapine) on intracellular levels of cytarabine in these patients. OUTLINE: This is a dose-escalation study of 3-AP (Triapine). Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP (Triapine) IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP (Triapine) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per stratum) will be accrued for this study within 15-24 months.

Official TitleA Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies 
NCT00077181
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blast CrisisBone Marrow DiseasesCell Transformation, NeoplasticChronic DiseaseHematologic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesRecurrenceLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, AcuteHematologic NeoplasmsDisease AttributesPrecursor Cell Lymphoblastic Leukemia-LymphomaCarcinogenesis

Criteria

Inclusion Criteria: * Histologically confirmed diagnosis of 1 of the following hematologic malignancies: * Relapsed or refractory acute myeloid leukemia (AML) * Relapsed or refractory acute lymphoblastic leukemia * Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML * Chronic myeloid leukemia in accelerated or blast phase * Refractory to standard therapy or no standard therapy exists * No known brain metastases * Performance status - CALGB 0-2 * Performance status - Karnofsky 60-100% * No G6PD deficiency * Bilirubin \< 2.0 mg/dL (unless due to Gilbert's syndrome) * AST and ALT \< 2.5 times upper limit of normal (ULN) * Creatinine \< 1.5 times ULN * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No pulmonary disease requiring oxygen * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs * No neuropathy * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness * No concurrent biologic agents * At least 72 hours since prior hydroxyurea * At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * No other concurrent chemotherapy * At least 2 weeks since prior radiotherapy * No concurrent radiotherapy * Recovered from all prior therapy * At least 4 weeks since prior investigational agents * No other concurrent investigational therapy * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and triapine IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Chicago Comprehensive Cancer Center

Chicago, United StatesSee the location
CompletedOne Study Center