Clinical trial · Interventional
IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)
A Phase I Study of Intravenous Plerixafor in Combination With Mitoxantrone Etoposide and Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia
NCT01027923CI-TRIAL-00016700AMLterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawal of support from sponsor
Summary
Brief summary (as posted)
In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.
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, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 320 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
- interventionNames
- Drug: Plerixafor
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 420 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5
- interventionNames
- Drug: Plerixafor
- Drug: Mitoxantrone
- Drug: Etoposide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Acute myeloid leukemia diagnosed according to WHO criteria with one of the following: * Primary refractory disease following ≥ 1 round of induction chemotherapy * First relapse or higher * Age between 18 and 70 years * ECOG performance status ≤ 2 * Adequate organ function defined as: * Creatinine ≤ 1.5 x institutional ULN * AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia) * ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia) * Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia) * Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram * Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study * Able to provide signed informed consent prior to registration on study Exclusion Criteria: * Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants) * Peripheral blood blast count ≥ 50 x 103 /mm3 * Active CNS involvement with leukemia * Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide * Pregnant or nursing * Concurrently receiving any other investigational agent * Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study * Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea) * Severe concurrent illness that would limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.