Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03388749|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Drug: Liposomal Annamycin||Phase 1 Phase 2|
Enrollment will occur in cohorts of 3 subjects in a conventional 3+3 escalating dose design, starting at a dose level of 120 mg/m2/day administered for 3 days. Dose escalation will take place on the basis of safety assessments in sequential cohorts of 3 subjects each. The initial cohort will receive 120 mg/m2/day for 3 days. For Cohorts 1, 2, 3, 4, and 5, dose escalation will occur in 30-mg/m2/day increments until subjects are enrolled at a 240-mg/m2/day dose. For Cohorts 6, 7, and 8, dose escalation will occur in 60-mg/m2/day increments until subjects are enrolled at a maximum dose of 420 mg/m2/day. Thus subsequent cohorts will receive 150, 180, 210, 240, 300, 360, and up to a maximum of 420 mg/m2/day for 3 days in the absence of safety concerns.
In each cohort during the dose escalation phase, if 1 of the 3 subjects experiences a DLT, the cohort of subjects at that dose level will be expanded to 6 subjects. If at least 2 of the 6 subjects experience a DLT, this will be considered a toxic dose and the next 3 subjects will be treated at a lower dose. The dose will be de-escalated in 30-mg/m2/day increments. As such, if at least 2 out of 6 subjects receiving 300, 360, or 420 mg/m2/day experience a DLT, the next 3 subjects will receive 270, 330, or 390 mg/m2/day, respectively. The MTD is defined as the highest dose of L-Annamycin at which fewer than 2 (of a cohort of up to 6) subjects experience a DLT.
Once the MTD/RP2D is identified, up to 21 additional subjects will be enrolled at the MTD/RP2D to better define toxicity and evaluate efficacy at this dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That Has Relapsed After Standard Induction Therapy|
|Actual Study Start Date :||December 17, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: Liposomal annamycin||
Drug: Liposomal Annamycin
2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
- Evaluation of safety and identification of the MTD/RP2D for L-Annamycin [ Time Frame: Day 1 through Day 28 ]The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of L-Annamycin in order to determine the MTD/RP2D
- Pharmacokinetics - Area under the plasma concentration [ Time Frame: Day 1 and Day 3 ]Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol
- Anti-leukemic activity [ Time Frame: Between Day 15 and Day 35 (+/- 3 days) ]Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003). Leukemia response rate will be evaluated by the investigator at the end of each L-Annamycin cycle based on bone marrow aspirate and peripheral blood evaluations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388749
|Contact: Robert Shepard, MDfirstname.lastname@example.org|
|Contact: Cynthia Abbateemail@example.com|
|Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego||Recruiting|
|Contact: Lidia Gil, MD, PhD|
|Contact: Agnieszka Nowak-Potoczek +48 669 349 039|
|Samodzielny Publiczny Szpital Kliniczny nr 1 im. Prof. Tadeusza Sokołowskiego w Szczecinie, Klinika Hematologii z Oddziałem Transplantacji Szpiku||Recruiting|
|Szczecin, Poland, 71-252|
|Contact: Sławomir Milczarek, MD firstname.lastname@example.org|
|Principal Investigator: Bogusław Machaliński, MD, PhD|
|Instytut Hematologii i Transfuzjologii, Klinika Hematologii||Recruiting|
|Warszawa, Poland, 02-776|
|Contact: Monika Jusko email@example.com|
|Principal Investigator: Ewa Lech-Maranda|
|Samodzielny Szpital Kliniczny nr 1||Recruiting|
|Wrocław, Poland, 50-367|
|Contact: Tomasz Wrobel, MD, PhD|
|Contact: Paula Jablonowska +48 533 193 182|
|Medical University of Lodz||Recruiting|
|Łódź, Poland, 93-510|
|Contact: Agnieszka Wierznowska, MD, PhD|
|Contact: Marta Robak firstname.lastname@example.org|
|Study Director:||Robert Shepard, MD||Moleculin Biotech, Inc.|