Quizartinib and Decitabine in Treating Participants With Untreated or Relapsed FLT3-ITD Mutated Acute Myeloid Leukemia or Myelodysplastic Syndrome
|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: NCT03661307|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia With FLT3/ITD Mutation Blasts More Than 10 Percent of Bone Marrow Nucleated Cells Blasts More Than 10 Percent of Peripheral Blood White Cells Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia Recurrent Myelodysplastic Syndrome||Drug: Decitabine Drug: Quizartinib||Phase 1 Phase 2|
I. To determine the overall response rate (ORR) including CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) + partial remission (PR) within 3 months of treatment initiation of quizartinib and decitabine combination in patients with newly diagnosed or relapsed FLT3-ITD mutated acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (> 10% blasts).
II. To determine the safety and maximum tolerable dose (MTD) of this combination.
I. To determine CR and CR+CRh rates within 3 months of treatment initiation of quizartinib and decitabine combination in patients with newly diagnosed or relapsed AML or or high risk MDS (> 10% blast).
II. To determine the duration of response (DOR), event-free survival (EFS), overall survival (OS), and number of patients bridged to hematopoietic stem cell transplant (HSCT) and median duration to HSCT from the initiation of the combination.
II. To investigate correlations of response to this combination with a pre-therapy, on-therapy, and progression 81-gene panel of gene mutations in AML.
I. To investigate possible relationships between response and non-response to the combination with pretherapy, on-therapy, and progression gene expression signatures.
II. To store and/or analyze surplus blood or tissue including bone marrow, if available, for potential future exploratory research into factors that may influence development of AML and/or response to the combination (where response is defined broadly to include efficacy, tolerability or safety).
OUTLINE: This is a phase I, dose escalation study followed by a phase I study.
Participants receive decitabine intravenously (IV) over 1 hour on days 1-10 and quizartinib orally (PO) every day beginning on day 5 of course 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3-6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Quizartinib in Combination With Decitabine for the Treatment of Patients With Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||October 31, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: Treatment (decitabine, quizartinib)
Participants receive decitabine IV over 1 hour on days 1-10 and quizartinib PO every day beginning on day 5 of course 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Maximum tolerated dose of the combination drugs (Phase I) [ Time Frame: Up to 28 days ]
- Incidence of adverse events (Phase II) [ Time Frame: Within 3 months ]
- Overall response rate (ORR) including CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) + partial remission (PR) (Phase II) [ Time Frame: Within 3 months ]
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): NCT03661307
|Contact: Musa Yilmazfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Musa Yilmaz 713-745-9945|
|Principal Investigator: Musa Yilmaz|
|Principal Investigator:||Musa Yilmaz||M.D. Anderson Cancer Center|