Low Dose Cytarabine and Lintuzumab-Ac225 in Older AML Patients
The study is a multicenter, open label Phase I/II trial.
The goal of the Phase I part of this study is to find the highest tolerable dose of Lintuzumab-Ac225 that can be given with cytarabine to patients with AML.
The goal of the Phase II part of this study is to learn if Lintuzumab-Ac225 and cytarabine can control AML. The safety of this drug combination will also be studied.
Lintuzumab-Ac225 is designed to deliver radiation therapy directly inside leukemia cells without giving any radiation to the surrounding normal cells
Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop the DNA from repairing itself.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Low Dose Cytarabine and Lintuzumab-Ac225 in Older Patients With Untreated Acute Myeloid Leukemia|
- Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225 [ Time Frame: Cycle 1, up to 52 days ] [ Designated as safety issue: Yes ]If two or more patients in a cohort experience dose limiting toxicity (DLT), then maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. If only three patients were treated at a dose level under consideration as the MTD, then up to three additional patients will be accrued. If no more than one of the six patients at that dose level experiences DLT, then that dose level will be confirmed as the MTD.
- Phase II: CR+CRp [ Time Frame: Up to 22 weeks from enrollment ] [ Designated as safety issue: No ]The primary objective is to determine the antileukemic effects, including its ability to produce complete remissions, of Lintuzumab-Ac225.
- Phase II: PFS [ Time Frame: 1 year ] [ Designated as safety issue: No ]Progression Free Survival
- Phase II: LFS [ Time Frame: 1 year ] [ Designated as safety issue: No ]Leukemia Free Survival
- Phase II: OS [ Time Frame: 1 year ] [ Designated as safety issue: No ]Overall Survival
- Phase II: Toxicity Spectrum [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Study Drug
Experimental: Cytarabine + Lintuzumab-Ac225 Cytarabine 20 mg subq every 12h, days 1 to 10 of each cycle. Starting dose 1.0 μCi/Kg Lintuzumab-Ac225 and 15 μg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given approx. 4-7 days after 1 cycle of low dose cytarabine and the second fraction given 4-7 days after the first fraction, followed by up to 11 more cycles. Lasix 40 mg po daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose. Spironolactone, 25 mg po daily, given 11 days after second dose of 225Ac-HuM195 (the day after furosemide completion) and continued for 12 months.
Low dose cytarabine administered at 20 mg subcutaneously every 12 hours for the first 10 days (Days 1 to 10) of every cycle. Cycle 1 can last up to 52 days (depending on the schedule of study drug dosing) in order to allow for recovery from Lintuzumab-Ac225. Cycles 2-12 will last 28 days each.
Other Names:Biological: Lintuzumab-Ac225
Starting dose level 1.0 μCi/Kg of Lintuzumab-Ac225 and 15 μg/Kg unlabeled HuM195 divided into 2 equal fractionated doses (0.5 μCi/Kg and 7.5 μg /Kg + 0.5 μCi/Kg and 7.5 μg /Kg) with the first fraction administered approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction administered 4-7 days after the first fraction, followed by up to 11 more cycles.
Other Names:Drug: Furosemide
40 mg by mouth daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose.
Other Name: LasixDrug: Spironolactone
25 mg by mouth daily, administered 11 days after second dose of 225Ac-HuM195 (the day after completion of furosemide) and continued for 12 months.
Other Name: Aldactone
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02575963
|Contact: Dragan Cicic, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Medicine||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: B. Douglas Smith, MD 410-955-8964 email@example.com|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jae Park, MD 646-497-9154 firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Alexander Perl, MD 215-573-8478 email@example.com|
|United States, Texas|
|Baylor Sammons Cancer Center||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: M. Yair Levy, MD 214-370-1000 Moshe.Levy@baylorhealth.edu|
|United States, Washington|
|Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Johnnie Orozco, MD PhD 206-667-4886 firstname.lastname@example.org|
|Principal Investigator:||Jae Park, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||M. Yair Levy, MD||Baylor College of Medicine|
|Study Chair:||Joseph Jurcic, MD||Columbia University|
|Principal Investigator:||B. Douglas Smith, MD||Kimmel Cancer Center at Johns Hopkins|
|Principal Investigator:||Johnnie Orozco, MD PhD||Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Alexander Perl||University of Pennsylvania|