Clinical trial · Interventional
Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia
Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia
NCT00906945CI-TRIAL-00026762completedPhase 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 designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- * G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 240 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
- interventionNames
- Drug: G-CSF
- Drug: Plerixafor
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- * G-CSF 10 mcg/kg SQ on Days 1-8 * Plerixafor 320 mcg/kg/d IV qd * Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8 * Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8 * Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8
- interventionNames
- Drug: G-CSF
- Drug: Plerixafor
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: * Primary refractory disease following no more than 2 cycles of induction chemotherapy * First relapse with no prior unsuccessful salvage chemotherapy 2. Age between 18 and 70 years old 3. ECOG performance status ≤ 3 4. Adequate organ function defined as: * Calculated creatinine clearance ≥ 50 ml/min * AST, ALT, total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia) * Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram 5. Are surgically or biologically sterile or willing to practice acceptable birth control, as follows: * Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence. * Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period 6. 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. Received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks 7. Received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study 8. Severe concurrent illness that would limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.