Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
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|ClinicalTrials.gov Identifier: NCT00943943|
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : March 29, 2017
The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AML. The safety of this combination will also be studied.
Funding Source - FDA OOPD
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Leukemia||Drug: G-CSF Drug: Plerixafor Drug: Sorafenib||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||G-CSF and Plerixafor With Sorafenib for Acute Myelogenous Leukemia With FLT3 Mutations|
|Actual Study Start Date :||October 29, 2010|
|Actual Primary Completion Date :||March 23, 2017|
|Actual Study Completion Date :||March 23, 2017|
Experimental: G-CSF and Plerixafor with Sorafenib
G-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections.
10 microgram/kg subcutaneous injection based on adjusted ideal body weight and administered in the evening (prior to the Plerixafor). The 1st dose on day -1 and every other day for 7 total doses. G-CSF administration of 7 every-other-day doses will be repeated every 28 days.
A fixed dose of 240 mcg/kg subcutaneous injection in the abdomen, calculated on ideal body weight. The 1st dose on day -1 and every other day for 7 total doses. Plerixafor administration of 7 every-other-day doses will be repeated every 28 days.
Other Name: Mobozil
First dose will be given right after G-CSF and plerixafor injections. Drug doses will be separated by intervals of approximately 12 hours (+/-2 hours).
Dose Level 0 = 400 mg orally twice daily.
- Maximum Tolerated Dose (MTD) of Sorafenib [ Time Frame: Participant toxicity rates evaluated at 8 weeks of treatment (2 cycles) ]MTD dose level of Sorafenib where less than two participants (2/3) experience Dose limiting toxicity (DLT), based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, is defined as ± Grade 3 nonhematological toxicity or nausea/vomiting (in the absence of appropriate antiemetics) that cannot be explained by intercurrent conditions such as infections and at least possibly related to the combination of agents in study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943943
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Andreeff, MD, PhD||M.D. Anderson Cancer Center|