Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04982354|
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : May 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: CPX-351 Drug: Midostaurin Drug: Busulfan Drug: Melphalan Drug: Fludarabine Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft|
|Actual Study Start Date :||July 5, 2022|
|Estimated Primary Completion Date :||August 1, 2031|
|Estimated Study Completion Date :||August 1, 2032|
Experimental: Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
For this trial, patients will be treated with CPX-351 100 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) for 3 doses on days 1, 3 and 5 of one and on days 1 + 3 of a second cycle of induction therapy, depending on response obtained following the first induction. Thereafter, up to 2 cycles of consolidation therapy of 2 doses on days 1 and 3 of daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 will be administered to the patients.
The FLT3 directed inhibitor, midostaurin, will be given at a dose of 50mg twice daily, starting on day 8 through day 21 of each cycle of CPX-351 until admission for allogeneic stem cell transplant.
Other Name: Rydapt
0.8 mg/kg/dose every six hours x 12 doses administered intravenously
Other Name: Myleran
70 mg/m2/day x 2 doses administered intravenously
Other Name: Alkeran
25 mg/m2/day x 5 doses administered intravenously
Other Name: Fludara
Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Allogeneic stem cell transplant infused intravenously
- Change in the complete remission rate [ Time Frame: 3, 6, 12 and 24 months ]Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients
- Change in Progression Free Survival (PFS) [ Time Frame: 3, 6, 12 and 24 months ]to determine the PFS of these patients following allo SCT. To estimate PFS the Kaplan-Meier method will be used.
- Change in Overall Survival (OS) [ Time Frame: 3, 6, 12 and 24 months ]to determine the OS of these patients following allo SCT. To estimate OS the Kaplan-Meier method will be used.
- Change in the rate of Minimal Residual Disease (MRD) negativity [ Time Frame: 3, 6, 12 and 24 months ]Ascertain the rate of MRD negativity by next generation sequencing at sequential time post following induction treatment at complete remission prior to allo Stem Cell Transplantation (SCT)
- Correlation of Minimal Residual Disease (MRD) [ Time Frame: 3, 6, 12 and 24 months ]Correlation of duration of MRD negative status with duration of complete remission of these patients will be assessed using Spearman's correlation with reported p value.
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): NCT04982354
|Contact: Guenther Koehne, MD, PhD||786-596-2000||GuentherK@Baptisthealth.net|
|United States, Florida|
|Miami Cancer Institute at Baptist Health of South Florida||Recruiting|
|Miami, Florida, United States, 33176|
|Contact: Guenther Koehne, MD, PhD 786-596-2000 GuentherK@Baptisthealth.net|
|Principal Investigator: Guenther Koehne, MD, PhD|
|Principal Investigator:||Guenther Koehne, MD. PhD||Miami Cancer Institute at Baptist Health of South Florida|