Clinical trial · Interventional
AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia
A Phase I/II Study of AMD3100 With Mitoxantrone, Etoposide and Cytarabine (AMD3100+MEC) in Relapsed or Refractory AML
NCT00512252CI-TRIAL-00025110AMD3100+MECcompletedPhase 1 / Phase 2Results postedClinicalTrials.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)
This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML. We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.
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 |
|---|---|---|---|
| AMD3100 | Drug | Plerixafor | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I Dose Escalation
- description
- * AMD3100 SQ on days 0-5 * Mitoxantrone on days 1-5 * Etoposide on days 1-5 * Cytarabine on days 1-5 Dose Level 1 AMD3100 dose = 80 mcg/kg/d Dose Level 2 AMD3100 dose = 160 mcg/kg/d
- interventionNames
- Drug: AMD3100
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- Phase II Dose Treatment
- description
- * AMD 3100 SQ on days 0-5 * Mitoxantrone on days 1-5 * Etoposide on days 1-5 * Cytarabine on days 1-5 Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)
- interventionNames
- Drug: AMD3100
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Acute myeloid leukemia diagnosed by WHO criteria with one of the following: 1. Primary refractory disease following \>= 1 rounds of induction chemotherapy 2. First relapse or higher 2. Age between 18 and 70 years of age 3. Adequate organ function defined as Creatinine \<= 1.5 x institutional ULN; AST, ALT, total bilirubin \<= 2 x ULN; Left ventricular ejection fraction of \>= 40% by MUGA scan 4. Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study 5. Able to provide signed informed consent prior to registration on study Exclusion Criteria: 1. Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants) 2. Peripheral blood blast count \> 20 x 103 /mm3 3. Active CNS involvement with leukemia 4. Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide 5. Pregnant or nursing 6. Receiving any other investigational agent 7. Colony stimulating factors filgrastim, pegfilgrastim or sargramostim within 2 weeks of study 8. Less than 2 weeks from the completion of any previous cytotoxic chemotherapy 9. Severe concurrent illness that would limit compliance with study requirements
References
Publications (1)
- DERIVEDUy GL, Rettig MP, Motabi IH, McFarland K, Trinkaus KM, Hladnik LM, Kulkarni S, Abboud CN, Cashen AF, Stockerl-Goldstein KE, Vij R, Westervelt P, DiPersio JF. A phase 1/2 study of chemosensitization with the CXCR4 antagonist plerixafor in relapsed or refractory acute myeloid leukemia. Blood. 2012 Apr 26;119(17):3917-24. doi: 10.1182/blood-2011-10-383406. Epub 2012 Feb 2. PMID 22308295