Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT07293403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine the efficacy of duvelisib maintenance therapy in peripheral T-cell lymphoma (PTCL) patients who have achieved a complete response (CR) following first-line treatment and are either ineligible for or decline consolidative autologous stem cell transplantation (ASCT).
SECONDARY OBJECTIVE:
I. Determine the tolerability and preliminary survival outcomes of duvelisib maintenance therapy.
EXPLORATORY OBJECTIVE:
I. Examine the association between biomarkers (e.g., minimal residual disease \[MRD\]) and clinical outcomes (overall response rate \[ORR\], progression free survival \[PFS\]).
OUTLINE:
Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who remain in continuous complete response may continue to receive duvelisib for an additional 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening, as well as positron emission tomography (PET)/computed tomography (CT) scans and blood sample collection throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study.
After completion of study treatment, patients are followed up at 4-6 weeks, then periodically for up to 5 years.
I. Determine the efficacy of duvelisib maintenance therapy in peripheral T-cell lymphoma (PTCL) patients who have achieved a complete response (CR) following first-line treatment and are either ineligible for or decline consolidative autologous stem cell transplantation (ASCT).
SECONDARY OBJECTIVE:
I. Determine the tolerability and preliminary survival outcomes of duvelisib maintenance therapy.
EXPLORATORY OBJECTIVE:
I. Examine the association between biomarkers (e.g., minimal residual disease \[MRD\]) and clinical outcomes (overall response rate \[ORR\], progression free survival \[PFS\]).
OUTLINE:
Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who remain in continuous complete response may continue to receive duvelisib for an additional 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening, as well as positron emission tomography (PET)/computed tomography (CT) scans and blood sample collection throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study.
After completion of study treatment, patients are followed up at 4-6 weeks, then periodically for up to 5 years.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-09029 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 25403 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |