Clinical trial · Interventional
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies
NCT00077181CI-TRIAL-00009114completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug. This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.85 |
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Recurrent Adult Acute Lymphoblastic Leukemia |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| triapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cytarabine and triapine)
- description
- 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.
- interventionNames
- Drug: cytarabine
- Drug: triapine
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- MTD defined as the dose preceding that at which greater than or equal to 2 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.