AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; JM 3100; Mitoxantrone; Plerixafor

Criteria

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