Know Cancer

or
forgot password

A Phase I Study of Intravenous Plerixafor in Combination With Mitoxantrone Etoposide and Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia


Phase 1
18 Years
70 Years
Not Enrolling
Both
Leukemia, Myeloid, Acute

Thank you

Trial Information

A Phase I Study of Intravenous Plerixafor in Combination With Mitoxantrone Etoposide and Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia


In this study, we are seeking to target the leukemia microenvironment to overcome disease
resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the
bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic
chemotherapy. In current formulations, the volume of plerixafor required to administer
doses higher than 240 mcg/kg may result in significant discomfort with repeated daily
injections. In this phase I extension study, we seek to test the safety of both higher
doses of plerixafor as well as intravenous dosing to maximize inhibition of the target,
CXCR4.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose and dose limiting toxicities of intravenous plerixafor when combined with MEC in patients with relapsed or refractory AML.

Outcome Time Frame:

Days 1-42

Safety Issue:

Yes

Principal Investigator

Geoffrey Uy, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

09-1825 / 201101703

NCT ID:

NCT01027923

Start Date:

May 2010

Completion Date:

September 2011

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110