Clinical trial · Interventional
Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse
NCT00112554CI-TRIAL-00012587completedPhase 3ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| laromustine | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction therapy arm I
- description
- Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
- interventionNames
- Drug: cytarabine
- Drug: laromustine
- type
- ACTIVE_COMPARATOR
- label
- Induction therapy arm II
- description
- Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
- interventionNames
- Drug: cytarabine
- Other: placebo
Primary outcomes (1)
- measure
- Overall response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (AML) * Any WHO classification, excluding acute promyelocytic leukemia * At least 10% blasts by bone marrow aspirate and/or biopsy * In first relapse after achieving a first complete response (CR) OR CR (with platelet count \< 100,000/mm³ but ≥ 20,000/mm³ \[transfusion independent for ≥ 7 consecutive days\]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen * Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 3 times ULN * Chronic hepatitis allowed Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No myocardial infarction within the past 3 months * No uncontrolled arrhythmias * No uncontrolled congestive heart failure Pulmonary * No severe chronic obstructive pulmonary disease * No requirement for supplemental oxygen at rest Immunologic * No uncontrolled active infection * Infections that are controlled and under active treatment with antibiotics allowed * No evidence of invasive fungal infection by blood or tissue cultures Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies * No other severe medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 12 hours since prior hydroxyurea Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior treatment while in first relapse except hydroxyurea * No other concurrent standard or investigational treatment for AML * No concurrent disulfiram (Antabuse®)
References
Publications (2)
- RESULTGiles F, Vey N, DeAngelo D, Seiter K, Stock W, Stuart R, Boskovic D, Pigneux A, Tallman M, Brandwein J, Kell J, Robak T, Staib P, Thomas X, Cahill A, Albitar M, O'Brien S. Phase 3 randomized, placebo-controlled, double-blind study of high-dose continuous infusion cytarabine alone or with laromustine (VNP40101M) in patients with acute myeloid leukemia in first relapse. Blood. 2009 Nov 5;114(19):4027-33. doi: 10.1182/blood-2009-06-229351. Epub 2009 Aug 26. PMID 19710500
- RESULTGiles FJ, Stock W, Vey N, et al.: A double blind placebo-controlled randomized phase III study of high dose continuous infusion cytosine arabinoside (araC) with or without cloretazine in patients with first relapse of acute myeloid leukemia (AML). [Abstract] Blood 108 (11): A-1970, 2006.