Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752163
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2021-02-03
Brief Title:
DS-1594b With or Without Azacitidine Venetoclax or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
An Open-Label Phase 12 Multi-Arm Study of DS-1594b as a Single-Agent and in Combination With Azacitidine and Venetoclax or Mini-HCVD for the Treatment of Patients With Acute Myeloid Leukemia AML and Acute Lymphoblastic Leukemia ALL
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial studies the effect of DS-1594b with or without azacitidine venetoclax or mini-HCVD in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back recurrent or not responded to treatment refractory Chemotherapy drugs such as azacitidine venetoclax and mini-HCVD work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading DS-1594b may inhibit specific protein bindings that cause blood cancer Giving DS-1594b azacitidine and venetoclax or mini-HCVD may work better in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia
Detailed Description:
OUTLINE This is a phase I dose-escalation study of DS-1594b followed by a phase II study
PHASE I Patients receive DS-1594b orally PO twice daily BID on days 1-28 in the absence of disease progression or unacceptable toxicity
DRUG-DRUG INTERACTION SUB-STUDY Patients receive DS-1594b PO BID on days 1-8 and 19-28 and posaconazole PO BID on day 9 and once daily QD on days 10-18 or voriconazole PO BID on days 9-18 in the absence of disease progression or unacceptable toxicity
FOOD-EFFECT SUB STUDY Patients receive DS-1594b PO BID on days 1-8 within 30 minutes after eating a standard meal and PO BID on days 9-15 under fasting conditions in the absence of disease progression or unacceptable toxicity
PHASE II Patients are assigned to 1 of 4 cohorts
COHORT A Patients with MLLr receive DS-1594b PO BID on days 1-28 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
COHORT B Patients with NPM1m receive DS-1594b PO BID on days 1-28 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
COHORT C Patients receive DS-1594b PO BID on days 1-28 venetoclax PO QD on days 1-28 and azacitidine intravenously IV or subcutaneously SC on days 1-7 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
COHORT D Patients receive DS-1594b PO BID on days 1-28 For cycles 1 3 5 7 patients also receive cyclophosphamide IV over 3 hours on days 1-3 mesna IV over 24 hours on days 1-3 vincristine IV on days 1 and 11 dexamethasone PO or IV on days 1-4 and 11-14 filgrastim SC on days 1-28 methotrexate intrathecally IT on day 2 of cycles 1 and 3 and cytarabine IT on day 7 of cycles 1 and 3 For cycles 2 4 6 8 patients also receive methotrexate IV over 24 hours on day 1 cytarabine BID IV over 3 hours on days 2 and 3 leucovorin IV or PO every 6 hours Q6H starting 12 hours after completion of methotrexate filgrastim SC days 1-28 cytarabine IT on day 5-8 of cycles 2 and 4 and methotrexate IT on days 8-11 of cycles 2 and 4 Patients with CD20 expression may also receive rituximab IV on days 1 and 11 of cycles 1 and 3 and days 1 and 8 of cycles 2 and 4 Cycles repeat every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients may then receive DS-1594b PO BID on days 1-28 vincristine IV over 15 minutes on day 7 and prednisone PO BID on days 1-5 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at days 30 and 100
PHASE I Patients receive DS-1594b orally PO twice daily BID on days 1-28 in the absence of disease progression or unacceptable toxicity
DRUG-DRUG INTERACTION SUB-STUDY Patients receive DS-1594b PO BID on days 1-8 and 19-28 and posaconazole PO BID on day 9 and once daily QD on days 10-18 or voriconazole PO BID on days 9-18 in the absence of disease progression or unacceptable toxicity
FOOD-EFFECT SUB STUDY Patients receive DS-1594b PO BID on days 1-8 within 30 minutes after eating a standard meal and PO BID on days 9-15 under fasting conditions in the absence of disease progression or unacceptable toxicity
PHASE II Patients are assigned to 1 of 4 cohorts
COHORT A Patients with MLLr receive DS-1594b PO BID on days 1-28 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
COHORT B Patients with NPM1m receive DS-1594b PO BID on days 1-28 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
COHORT C Patients receive DS-1594b PO BID on days 1-28 venetoclax PO QD on days 1-28 and azacitidine intravenously IV or subcutaneously SC on days 1-7 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
COHORT D Patients receive DS-1594b PO BID on days 1-28 For cycles 1 3 5 7 patients also receive cyclophosphamide IV over 3 hours on days 1-3 mesna IV over 24 hours on days 1-3 vincristine IV on days 1 and 11 dexamethasone PO or IV on days 1-4 and 11-14 filgrastim SC on days 1-28 methotrexate intrathecally IT on day 2 of cycles 1 and 3 and cytarabine IT on day 7 of cycles 1 and 3 For cycles 2 4 6 8 patients also receive methotrexate IV over 24 hours on day 1 cytarabine BID IV over 3 hours on days 2 and 3 leucovorin IV or PO every 6 hours Q6H starting 12 hours after completion of methotrexate filgrastim SC days 1-28 cytarabine IT on day 5-8 of cycles 2 and 4 and methotrexate IT on days 8-11 of cycles 2 and 4 Patients with CD20 expression may also receive rituximab IV on days 1 and 11 of cycles 1 and 3 and days 1 and 8 of cycles 2 and 4 Cycles repeat every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients may then receive DS-1594b PO BID on days 1-28 vincristine IV over 15 minutes on day 7 and prednisone PO BID on days 1-5 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at days 30 and 100
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0946 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-00603 | REGISTRY | None | None |