Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT07278856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Ruxolitinib in Combination With Chemotherapy for Untreated Nodal T-Follicular Helper (TFH) Cell Lymphomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
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 I trial tests the safety, side effects and best dose of ruxolitinib in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy and how well the combination works in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma. Ruxolitinib phosphate blocks a protein called janus kinase, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response. Ruxolitinib phosphate is a type of tyrosine kinase inhibitor. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Doxorubicin is a type of anthracycline antitumor antibiotic. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving ruxolitinib in combination with CHOP chemotherapy may be safe, tolerable, and/or effective in treating patients with untreated nodal TFH cell lymphoma.
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine the safety of ruxolitinib phosphate (ruxolitinib) in combination with CHOP chemotherapy in untreated nodal TFH cell lymphoma patients.
SECONDARY OBJECTIVES:
I. Determine the tolerability and preliminary clinical efficacy of Ia. Ruxolitinib in combination with CHOP chemotherapy in untreated nodal TFH cell lymphoma; Ib. Ruxolitinib monotherapy maintenance for nodal TFH cell lymphoma patients who achieve a response (partial response \[PR\] or complete response \[CR\]) with ruxolitinib + CHOP chemotherapy.
EXPLORATORY OBJECTIVES:
I. Describe preliminary survival outcomes. II. Describe the relative dose intensity of CHOP chemotherapy backbone.
OUTLINE:
PART A: Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-21, cyclophosphamide intravenously (IV), doxorubicin IV, vincristine IV, on day 1 and prednisone PO once daily (QD) on days 1-5 of each cycle. Patients also receive pegfilgrastim subcutaneously (SC) 24-72 hours after last dose of treatment, filgrastim SC starting 1 day after last dose of treatment until absolute neutrophil count (ANC) \> 1000/uL. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PR or CR and are ineligible for or decline consolidative autologous stem cell transplantation (ASCT) proceed to Part B.
PART B: Patients receive ruxolitinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After the first year of monotherapy maintenance, patients who remain in continuous CR or PR (compared to baseline imaging before Part A) may optionally continue to receive ruxolitinib for an additional 12 cycles.
Additionally, patients undergo bone marrow biopsy and aspiration and multigated acquisition scan (MUGA) or echocardiography (ECHO) at screening, blood sample collection, fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) and CT throughout the study.
After completion of study treatment, patients are followed up at 30 days then for up to 5 years.
I. Determine the safety of ruxolitinib phosphate (ruxolitinib) in combination with CHOP chemotherapy in untreated nodal TFH cell lymphoma patients.
SECONDARY OBJECTIVES:
I. Determine the tolerability and preliminary clinical efficacy of Ia. Ruxolitinib in combination with CHOP chemotherapy in untreated nodal TFH cell lymphoma; Ib. Ruxolitinib monotherapy maintenance for nodal TFH cell lymphoma patients who achieve a response (partial response \[PR\] or complete response \[CR\]) with ruxolitinib + CHOP chemotherapy.
EXPLORATORY OBJECTIVES:
I. Describe preliminary survival outcomes. II. Describe the relative dose intensity of CHOP chemotherapy backbone.
OUTLINE:
PART A: Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-21, cyclophosphamide intravenously (IV), doxorubicin IV, vincristine IV, on day 1 and prednisone PO once daily (QD) on days 1-5 of each cycle. Patients also receive pegfilgrastim subcutaneously (SC) 24-72 hours after last dose of treatment, filgrastim SC starting 1 day after last dose of treatment until absolute neutrophil count (ANC) \> 1000/uL. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PR or CR and are ineligible for or decline consolidative autologous stem cell transplantation (ASCT) proceed to Part B.
PART B: Patients receive ruxolitinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After the first year of monotherapy maintenance, patients who remain in continuous CR or PR (compared to baseline imaging before Part A) may optionally continue to receive ruxolitinib for an additional 12 cycles.
Additionally, patients undergo bone marrow biopsy and aspiration and multigated acquisition scan (MUGA) or echocardiography (ECHO) at screening, blood sample collection, fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) and CT throughout the study.
After completion of study treatment, patients are followed up at 30 days then 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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-08060 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 25404 | OTHER | City of Hope Comprehensive Cancer Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |