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Ruxolitinib + CHOP

Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas

  • RegistryNCT07278856
  • PhasePhase 1
  • StatusRecruiting
  • ConditionUntreated Nodal T Follicular Helper Cell Lymphoma
  • SponsorCity of Hope Medical Center
How Ruxolitinib + CHOP works1 min

The drug

What is being tested.

Undergo bone marrow biopsy and aspiration

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.

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Ability to understand and willingness to sign a written informed consent document
  • Documented informed consent of the participant and/or legally authorized representative.
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Be ≥ 18 years of age on day of signing informed consent
  • Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale (PS) at time of enrollment. Patients with a performance status of 2 on the ECOG scale due to lymphoma may be eligible with principal investigator (PI) approval

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

For you, or someone you love

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How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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