A Phase 1/2 interventional study of CPX-351 and Midostaurin in Acute Myeloid Leukemia, sponsored by Guenther Koehne. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Guenther Koehne · Phase 1/2, Interventional, and Treatment
This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
Browse Leukemia, Myeloid, Acute studies →Guenther Koehne is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Drug: CPX-351 · Drug: Midostaurin · Drug: Busulfan · Drug: Melphalan · Drug: Fludarabine · Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
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.
Also known as: Rydapt
0.8 mg/kg/dose every six hours x 12 doses administered intravenously
Also known as: Myleran
70 mg/m2/day x 2 doses administered intravenously
Also known as: Alkeran
25 mg/m2/day x 5 doses administered intravenously
Also known as: Fludara
Allogeneic stem cell transplant infused intravenously
Change in the complete remission rate
Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients
Time frame: 3, 6, 12 and 24 months
Change in Progression Free Survival (PFS)
to determine the PFS of these patients following allo SCT. To estimate PFS the Kaplan-Meier method will be used.
Time frame: 3, 6, 12 and 24 months
Change in Overall Survival (OS)
to determine the OS of these patients following allo SCT. To estimate OS the Kaplan-Meier method will be used.
Time frame: 3, 6, 12 and 24 months
Change in the rate of Minimal Residual Disease (MRD) negativity
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)
Time frame: 3, 6, 12 and 24 months
Correlation of Minimal Residual Disease (MRD)
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.
Time frame: 3, 6, 12 and 24 months
This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: CPX-351 · Midostaurin
Guenther Koehne