CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04231851|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia (AML) Due to Therapy Acute Myeloid Leukemia With Myelodysplasia-Related Changes||Drug: Glasdegib Drug: CPX-351||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Combination of CPX-351 and Glasdegib in Previously Untreated Patients With Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia|
|Actual Study Start Date :||February 19, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: CPX-351 and Glasdegib
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Other Name: DAURISMO™
- Percentage of Participants with Event-Free Survival at 6 months [ Time Frame: 6 months ]This is defined as the percentage of subjects with event-free survival (EFS) at 6 months. EFS is defined as the number of months where patients are in a remission state.
- Percentage of Grade 3-5 Adverse Events [ Time Frame: From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. ]To evaluate the tolerability of administering CPX-351 in combination with glasdegib in patients with newly diagnosed with Acute Myeloid Leukemia (AML) with Myelodysplastic Syndrome (MDS) related changes or treatment-related AML from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
- Overall Response Rate [ Time Frame: From the start date of treatment until first date of CR/CRi or an average of 1 year. ]To assess the overall response rate to the combination of CPX-351 and glasdegib. The overall response rate (ORR) is defined as the rate of complete remissions (CR) and complete remission with incomplete count recovery (CRi). ORR = CR + CRi
- Durability of Response [ Time Frame: From the start date of treatment until first date of CR/CRi or an average of 1 year. ]Durability of response is measured by relapse-free survival (RFS). RFS is defined as the amount of time a patient remains in remission after having achieved a CR or CRi
- Overall Survival of Patients who received the combination of CPX-351 and glasdegib [ Time Frame: Time from screening biopsy for up to 12 months after the last patient is enrolled or until death from any cause, whichever came first. ]To evaluate the overall survival of patients with newly diagnosed with Acute Myeloid Leukemia (AML) with Myelodysplastic Syndrome (MDS) related changes or treatment-related AML.
- Time to normal hematopoiesis as assessed by laboratory studies [ Time Frame: From the start date of treatment until laboratory studies confirmation of normal hematopoiesis or an average of 1 year ]To evaluate the time to normal hematopoiesis, process by which blood cells are formed, as determined by laboratory studies inclusive of complete blood counts (CBCs)
- Number of participants who go on to receive an allogenic hematopoietic stem cell transplant [ Time Frame: Up to 3 years ]This is defined as the number of participants who continue on to receive an allogenic hematopoietic stem cell transplant after induction, re-induction, or consolidation.
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): NCT04231851
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvinefirstname.lastname@example.org|
|Contact: University of California Irvine Medical|
|United States, California|
|Chao Family Comprehensive Cancer Center, University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Deepa Jeyakumar, MD 877-827-8839 email@example.com|
|Principal Investigator:||Deepa Jeyakumar, MD||Chao Family Comprehensive Cancer Center|