Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-10 @ 12:24 AM
Study NCT ID:
NCT03701295
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2018-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase Ib/II Study of the Histone Methyltransferase Inhibitor Pinometostat in Combination With Azacitidine in Patients With 11q23-Rearranged Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2023-09
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 Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or is newly diagnosed, with an 11q23 rearrangement. Pinometostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine if the combination of pinometostat, at a dose of 54 or 90 mg/m\^2/day, and azacitidine, at a dose of 75 mg/m\^2 daily for 7 days, is safe and tolerable in patients with MLL-rearranged acute myeloid leukemia, either in the relapsed/ refractory setting or in those who choose not to undergo standard induction therapy in the previously untreated setting. (Phase Ib) II. To determine the preliminary efficacy, as determined by overall response rate (complete response \[CR\], complete response with incomplete bone marrow recovery \[CRi\], partial response \[PR\], and morphologic leukemia-free state \[MLFS\]), of pinometostat administered at the maximum tolerated dose from the phase 1b, combined with azacitidine administered at 75 mg/m\^2 daily for 7 days, in patients with MLL-rearranged acute myeloid leukemia, either in the relapsed/refractory setting or in those who choose not to undergo standard induction therapy in the previously untreated setting. (Phase II)
SECONDARY OBJECTIVES:
I. Perform correlative studies to evaluate for on-target effects, cellular differentiation, and decreased leukemia cell proliferation in these patients. (Phase Ib and II) II. To observe and record anti-tumor activity. (Phase Ib)
OUTLINE: This is a phase Ib, dose-escalation study of pinometostat followed by a phase II study.
Patients receive pinometostat intravenously (IV) continuously on days 1-28 and azacitidine IV over 10-40 minutes or subcutaneously (SC) for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month.
I. To determine if the combination of pinometostat, at a dose of 54 or 90 mg/m\^2/day, and azacitidine, at a dose of 75 mg/m\^2 daily for 7 days, is safe and tolerable in patients with MLL-rearranged acute myeloid leukemia, either in the relapsed/ refractory setting or in those who choose not to undergo standard induction therapy in the previously untreated setting. (Phase Ib) II. To determine the preliminary efficacy, as determined by overall response rate (complete response \[CR\], complete response with incomplete bone marrow recovery \[CRi\], partial response \[PR\], and morphologic leukemia-free state \[MLFS\]), of pinometostat administered at the maximum tolerated dose from the phase 1b, combined with azacitidine administered at 75 mg/m\^2 daily for 7 days, in patients with MLL-rearranged acute myeloid leukemia, either in the relapsed/refractory setting or in those who choose not to undergo standard induction therapy in the previously untreated setting. (Phase II)
SECONDARY OBJECTIVES:
I. Perform correlative studies to evaluate for on-target effects, cellular differentiation, and decreased leukemia cell proliferation in these patients. (Phase Ib and II) II. To observe and record anti-tumor activity. (Phase Ib)
OUTLINE: This is a phase Ib, dose-escalation study of pinometostat followed by a phase II study.
Patients receive pinometostat intravenously (IV) continuously on days 1-28 and azacitidine IV over 10-40 minutes or subcutaneously (SC) for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-02128 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 10200 | OTHER | JHU Sidney Kimmel Comprehensive Cancer Center LAO | View | |
| 10200 | OTHER | CTEP | View | |
| UM1CA186691 | NIH | None | https://reporter.nih.gov/quic… | View |