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IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia, Myeloid, Acute

Intervention: Plerixafor (Drug); Mitoxantrone (Drug); Etoposide (Drug); Cytarabine (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Geoffrey Uy, M.D., Principal Investigator, Affiliation: Washington University School of Medicine

Summary

In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

Clinical Details

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

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

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

Secondary outcome:

To determine the complete response rate (CR) for plerixafor when combined with MEC in patients with relapsed or refractory AML.

To determine the safety and tolerability of plerixafor in combination with MEC

To determine the PK and explore potential PK drug-drug interactions between plerixafor and MEC.

To determine the time to hematologic recovery

To characterize the mobilization of leukemic cells with plerixafor plus G-CSF.

To characterize the effects of plerixafor plus G-CSF on SDF-1/CXCR4 signaling on leukemic blasts.

To determine the time to overall survival

To determine the time to event-free survival

To determine the time to duration of remission

To determine the time to relapse-free survival

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information

Starting date: May 2010
Last updated: January 21, 2015

Page last updated: August 23, 2015

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