Clinical trial · Interventional
Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia
Phase 1 Study Evaluating the Tolerance and Biologic Activity of Intravenous Infusions of Tigecycline in Patients With Relapsed or Refractory AML
NCT01332786CI-TRIAL-00017529completedPhase 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)
The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with 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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tigecycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tigecycline
- interventionNames
- Drug: Tigecycline
Primary outcomes (1)
- measure
- Toxicity evaluated according to CTCAE version 4.03
- timeFrame
- Reviewed at each visit and assessed at the end of each 3-week cycle
Secondary outcomes (1)
- measure
- Response rate assessment of tigecycline through laboratory assessments
- timeFrame
- Assessed at the end of each 3-week cycle for the study duration
- description
- Bone marrow assessment, absolute neutrophil count, platelet counts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Diagnosis of relapsed or refractory AML for which all potentially curative or standard salvage therapy options have been exhausted; OR AML without prior treatment who are not eligible for induction chemotherapy as defined as age \> or equal to 80 or age \> 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as LVEF less than 40% and/or DlCO less than 60% expected * ECOG 0-2 performance status * Biochemical values within the following range * Serum creatinine \<2x upper limit of normal * Total bilirubin \<1.5x upper limit of normal * AST and ALT \<2x upper limit of normal * Recovery from non-hematologic toxicity from prior chemotherapy * Able and willing to provide informed consent Exclusion Criteria: * Allergy to tetracycline or minocycline * Uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection * Active systemic bacterial, fungal, or viral infection * Concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis * Pregnant or breast feeding * Known active CNS involvement with AML * Neurologic symptoms related to uncontrolled illnesses or unexplained causes * Psychiatric illness that would limit compliance with study * Receiving systemic chemotherapy other than hydroxyurea to control circulating blast counts. Concomitant hydroxyurea is permitted, but only in the first cycle of therapy * Prior therapy with tigecycline as an anti-cancer therapy or any use of the drug in the last month * Use of other investigational anti-leukemic therapy within 14 days of registration
References
Publications (0)
Data not yet available
No reference posted for this study.