SL-401 in Combination With Azacitidine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
|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: NCT03113643|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : January 17, 2018
This research study is studying a drug as a possible treatment for diagnosis of AML and high-risk MDS.
The interventions involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndrome||Drug: Azacitidine Drug: SL-401||Phase 1|
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has approved Azacitidine as a treatment option for this disease. SL-401 is an investigational drug, which means it is not approved by the FDA as a treatment for any disease.
In this research study, the study drug SL-401 will be combined with the standard dose of azacitidine. The goal of this research study is to try and determine the safest, highest dose of study drug, SL-401, in combination with azacitidine that can be given to patients with AML or high-risk MDS. SL-401 works by stopping or slowing the growth of cancer stem cells, which are the undeveloped cells which can develop into cancer cells. The goals of this research study are to look at if this combination works to help treat cancer and if there is any lasting effect of this combination . This study will also look at how the SL-401, in combination with azacitidine, affects certain proteins in the blood and bone marrow. SL-401 has been given to patients with AML and MDS in the past, but this is the first time it will be given in combination with another drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of SL-401 in Combination With Azacitidine in Relapsed/Refractory Acute Myeloid Leukemia (AML) or in Treatment-Naive AML Not Eligible for Standard Therapy or in Subjects With High-Risk Myelodysplastic Syndrome (MDS)|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||May 31, 2023|
Experimental: SL-401+ Azacitidine
SL-401 will be administered every 4 weeks, on a 28 day cycle; SL-401 will be given intravenously; Azacitidine will be administered every 4 weeks, on a 28 day cycle; Azacitidine will be given intravenously or subcutaneously
Other Name: Vidaza
SL-401 works by targeting leukemia cells (blasts), and also possibly by stopping or slowing the growth of cancer stem cells, which are the undeveloped cells which can develop into cancer cells.
- Maximum Tolerated Dose [ Time Frame: 2 years ]
- Complete Response Rate [ Time Frame: 2 years ]
- Time to response and duration of response [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
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): NCT03113643
|Contact: Andrew Lane, MD, PhDfirstname.lastname@example.org|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Anthony Stein, MD 626-359-8111 AStein@coh.org|
|Principal Investigator: Anthony Stein, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Andrew Lane, MD, PhD 617-632-4589 email@example.com|
|Principal Investigator: Andrew Lane, MD, PhD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Naveen Pemmaraju, MD 713-792-4956 firstname.lastname@example.org|
|Principal Investigator: Naveen Pemmaraju, MD|
|Principal Investigator:||Andrew Lane, MD, PhD||Dana-Farber Cancer Institute|