Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03318016|
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : April 30, 2021
Determine the maximum tolerated dose (MTD) and toxicity profile of the combination of cyclophosphamide and ATO (Arsenic Trioxide) in subjects with relapsed refractory AML.
Determine the efficacy of ATO and cyclophosphamide in this population, as defined by response rate, response duration, event-free survival (EFS) and overall survival (OS).
Determine the number of transplant-eligible subjects who are successfully bridged to stem cell transplantation or donor lymphocyte infusion.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Relapsed/Refractory Acute Myeloid Leukemia||Drug: Cyclophosphamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
ATO and Cyclophosphamide will be repeated every 28 days.
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||December 15, 2017|
|Actual Primary Completion Date :||January 15, 2020|
|Actual Study Completion Date :||January 20, 2021|
ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide on day 4 as a single IV dose along with Mesna (in subjects receiving >1000mg/m2 Cy) and hydration for a maximum of 6 doses in the following dose escalation schema:
- Maximally Tolerated Dose (MTD) of Cyclophosphamide and ATO [ Time Frame: 6 months ]MTD is defined as the highest dose level with no more than 1 DLT reported out of 6 DLT-evaluable subjects.
- Overall Response Rate (ORR) using ATO and Cyclophosphamide [ Time Frame: minimum 5 years ]ORR defined by complete remission/complete remission with incomplete recovery of blood counts (CR/CRi), morphologic leukemia free state (MLFS) and partial responses (PR)
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): NCT03318016
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Daniel Pollyea, MD||University of Colorado, Denver|