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| Name | Class |
|---|---|
| Jazz Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Treatment | Experimental | Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPX-351 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the complete remission rate | Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients | 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. | 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. | 3, 6, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3, 6, 12 and 24 months |
| Correlation of Minimal Residual Disease (MRD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guenther Koehne, MD. PhD | Miami Cancer Institute at Baptist Health of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health of South Florida | Miami | Florida | 33176 | United States |
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| Label | URL |
|---|---|
| Miami Cancer Institute Website | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000629812 | CPX-351 |
| C059539 | midostaurin |
| D002066 | Busulfan |
| D008558 | Melphalan |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Midostaurin | Drug | 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. |
|
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| Busulfan | Drug | 0.8 mg/kg/dose every six hours x 12 doses administered intravenously |
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| Melphalan | Drug | 70 mg/m2/day x 2 doses administered intravenously |
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| Fludarabine | Drug | 25 mg/m2/day x 5 doses administered intravenously |
|
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| CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor | Biological | Allogeneic stem cell transplant infused intravenously |
|
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. |
| 3, 6, 12 and 24 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |