Phase 2
N=52
AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia
Leukemia, Myeloid, Acute
Bottom Line
View on ClinicalTrials.gov: NCT00512252 ↗Enrolled (actual)
52
Serious AEs
5.8%
Results posted
Sep 2014
Primary outcome: Primary: Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML — 240 mcg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AMD3100 (Drug); Mitoxantrone (Drug); Etoposide (Drug); Cytarabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML |
240 | — |
| PRIMARY Phase II Only: Complete Response Rate of AMD3100 + MEC |
56; 20; 25; 46; 47; 20 | — |
| PRIMARY Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions |
— | — |
| SECONDARY Safety and Tolerability of AMD3100 + MEC. |
2; 1 | — |
| SECONDARY Time to Neutrophil Recovery |
28 | — |
| SECONDARY Time to Platelet Recovery |
28.5 | — |
| SECONDARY Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I) |
2.5; 4.7; 3.5; 4.3; 7.0; 6.4 | — |
| SECONDARY Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I) |
46.0; 4.0; 43.5; 26.0; 9.0; 30.5 | — |
| SECONDARY Pharmacokinetics of AMD3100 on MEC |
— | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Treatment Failure |
12; 6; 3; 21; 1; 2 | — |
| SECONDARY Overall Survival |
37 | — |
| SECONDARY Relapse-free Survival |
42.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
- Primary refractory disease following >= 1 rounds of induction chemotherapy
- First relapse or higher
- Age between 18 and 70 years of age
- Adequate organ function defined as Creatinine = 40% by MUGA scan
- 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 > 20 x 103 /mm3
- Active CNS involvement with leukemia
- Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
- Pregnant or nursing
- Receiving any other investigational agent
- Colony stimulating factors filgrastim, pegfilgrastim or sargramostim within 2 weeks of study
- Less than 2 weeks from the completion of any previous cytotoxic chemotherapy
- Severe concurrent illness that would limit compliance with study requirements
Data sourced from ClinicalTrials.gov (NCT00512252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.