Ignite Creation Date:
2024-05-06 @ 2:45 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02115295
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2014-04-14
Brief Title:
Cladribine Idarubicin Cytarabine and Venetoclax in Treating Patients With Acute Myeloid Leukemia High-Risk Myelodysplastic Syndrome or Blastic Phase Chronic Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine ARAC in Patients With AML HR MDS or Myeloid Blast Phase of CML
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well cladribine idarubicin cytarabine and venetoclax work in patients with acute myeloid leukemia high-risk myelodysplastic syndrome or blastic phase chronic myeloid leukemia Drugs used in chemotherapy such as cladribine idarubicin cytarabine and venetoclax 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
Detailed Description:
Primary Objectives
I To determine the complete response rate CR of cladribine in combination with idarubicin and cytarabine araC in patients with acute myeloid leukemia AML high risk HR myelodysplastic syndrome MDS or myeloid blast phase of chronic myeloid leukemia CML
Secondary Objectives
I To determine the overall response rate ORR of cladribine in combination with idarubicin and araC in patients with AML HR MDS or myeloid blast phase of CML
II To assess overall survival OS and event free survival EFS of patients treated with cladribine idarubicin and araC cytarabine
III To assess the duration of response to the combination in patients with AML HR MDS or myeloid blast phase of CML
IV To determine the safety and tolerability of the combination in patients with AML HR MDS or myeloid blast phase of CML
Exploratory Objectives
I To study and describe the relationship between pretreatment patientdisease characteristics including AML-associated molecular abnormalities and outcome
II To identify molecular biomarkers predictive of response to therapy
III To study and describe the relationship between patientdisease characteristics use of intrathecal prophylaxis and incidence of leptomeningeal disease
IV To study the trajectories of leukemia mutations and molecular minimal residual disease MRD during the therapy
OUTLINE
INDUCTION Patients receive cladribine intravenously IV and cytarabine IV over 1-2 hours on days 1-5 and idarubicin IV over 30-60 minutes on days 1-3 Patients with untreated AML and MDS also receive venetoclax orally PO on days 2-8 AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO twice daily BID on days 6-19 or gilteritinib PO once daily QD on days 1-14 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity
CONSOLIDATION Patients receive cladribine IV and cytarabine IV over 1-2 hours on days 1-3 and idarubicin IV over 30-60 minutes on days 1-2 Patients with untreated AML and MDS also receive venetoclax PO on days 2-8 AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO BID on days 6-19 or gilteritinib PO QD Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6-12 months
I To determine the complete response rate CR of cladribine in combination with idarubicin and cytarabine araC in patients with acute myeloid leukemia AML high risk HR myelodysplastic syndrome MDS or myeloid blast phase of chronic myeloid leukemia CML
Secondary Objectives
I To determine the overall response rate ORR of cladribine in combination with idarubicin and araC in patients with AML HR MDS or myeloid blast phase of CML
II To assess overall survival OS and event free survival EFS of patients treated with cladribine idarubicin and araC cytarabine
III To assess the duration of response to the combination in patients with AML HR MDS or myeloid blast phase of CML
IV To determine the safety and tolerability of the combination in patients with AML HR MDS or myeloid blast phase of CML
Exploratory Objectives
I To study and describe the relationship between pretreatment patientdisease characteristics including AML-associated molecular abnormalities and outcome
II To identify molecular biomarkers predictive of response to therapy
III To study and describe the relationship between patientdisease characteristics use of intrathecal prophylaxis and incidence of leptomeningeal disease
IV To study the trajectories of leukemia mutations and molecular minimal residual disease MRD during the therapy
OUTLINE
INDUCTION Patients receive cladribine intravenously IV and cytarabine IV over 1-2 hours on days 1-5 and idarubicin IV over 30-60 minutes on days 1-3 Patients with untreated AML and MDS also receive venetoclax orally PO on days 2-8 AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO twice daily BID on days 6-19 or gilteritinib PO once daily QD on days 1-14 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity
CONSOLIDATION Patients receive cladribine IV and cytarabine IV over 1-2 hours on days 1-3 and idarubicin IV over 30-60 minutes on days 1-2 Patients with untreated AML and MDS also receive venetoclax PO on days 2-8 AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO BID on days 6-19 or gilteritinib PO QD Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6-12 months
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 |
|---|---|---|---|
| 2012-0648 | OTHER | M D Anderson Cancer Center | None |
| NCI-2014-01103 | REGISTRY | None | None |