MDACC Study Summary 2011-0036

Study Summary
No. 2011-0036:.......Leukemia......Marina Konopleva......Leukemia

Study Summary Title



Study Summary Number:	2011-0036

Study Title:	Chemosensitization with Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia

Physician

New Patient Referral



Name:	Marina Konopleva	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1628 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Genzyme Washington University Schoold of Medicine

Phase of Study:	Phase I/Phase II	Return Visit:

Treatment Agents:	Cytarabine Etoposide G-CSF Mitoxantrone Plerixafor	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:

Description/
Intervention:

The goal of the first phase of this clinical research study is to learn the
highest tolerable dose of plerixafor that can be given with G-CSF and the
standard of care chemotherapy drugs mitoxantrone, etoposide, and cytarabine
(MEC).

Plerixafor is designed to cause blood cells (blasts) to move out of the bone
marrow and into the blood stream where MEC may attack and kill the cancer cells.

MEC is commonly used in the treatment of AML. In this study, G-CSF is given to
help plerixafor to drive leukemic cells from the bone marrow.

Once the first phase of the study is completed, the second phase of the study
will determine whether the combination of plerixafor with G-CSF and MEC can be
more effective in treating leukemia than MEC alone.

Study Objectives / Outcomes

Primary objectives

Phase I: To determine the maximum tolerated dose of plerixafor plus G-CSF when combined with mitoxantrone, etoposide and cytarabine (MEC) in patients with relapsed or refractory AML.

Phase II: To determine the complete response rate (CR+CRi) for plerixafor plus G-CSF when combined with MEC in patients with relapsed or refractory AML.

Secondary objectives
1. To determine the safety and tolerability.
2. To determine the time to hematologic recovery, time to progression, time to treatment failure, and overall survival.
3. To characterize the mobilization of leukemic cells with plerixafor plus G-CSF.
4. To characterize the effects of plerixafor plus G-CSF on SDF-1/CXCR4 signaling on leukemic blasts.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/29/2011

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	70

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Acute myeloid leukemia diagnosed by WHO criteria^60 with one of the following: a. Primary refractory disease following >/= 1 round of induction chemotherapy b. First relapse or higher

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: (i)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. (ii) Males must agree to abstain from sexual activity or agree to utilize a medally approve 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 10^3 /mm^3

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

Links

Registration Number: NCT00906945
Study Information on Clinical Trials Registry (clinicaltrials.gov)