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New treatment option for Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Official title A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
ClinicalTrials.gov ID: NCT05934513
What this study is testing
What is GFH009?
GFH009 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory peripheral t-cell lymphoma (ptcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female ≥ 18 years and ≤ 75 years.
- Written informed consent must be obtained prior to any screening procedures.
- Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
- Must have received and failed at least 2 but no more than 5 prior lines of therapies .
- Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
You likely can't join if
- Diagnosis of Cutaneous T-cell lymphoma .
- Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Patients with severe hemophagocytic syndrome at screening.
- Presence of uncontrolled third space effusion
- Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug; or...
- History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.
See the full eligibility criteria
- Male or female ≥ 18 years and ≤ 75 years.
- Written informed consent must be obtained prior to any screening procedures.
- Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
- Must have received and failed at least 2 but no more than 5 prior lines of therapies .
- Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
- Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.
- Eastern Cooperative Oncology Group performance status of ≤ 2.
- Adequate haematologic and organ function at screening.
- Life expectancy ≥ 12 week.
- Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and \< Grade 2 sensory neuropathy.
- For women of childbearing potential, she must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug. Men with a...
- Diagnosis of Cutaneous T-cell lymphoma .
- Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression.
- Patients with severe hemophagocytic syndrome at screening.
- Presence of uncontrolled third space effusion
- Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug; or undergone major surgery with 4 weeks; or received targeted therapy within...
- History of allogeneic stem cell transplant or autologous HCT within 90 days before screening.
- Attend other clinical trial within 2 weeks prior to starting study drug.
- History of previous exposure to any other CDK9 inhibitor.
- Concurrent malignancy within 5 years prior to entry
- Uncontrolled pulmonary fibrosis, active lung diseases or interstitial lung disease.
- Severe cardiovascular disease
- people with high risk of gastrointestinal hemorrhage.
- Uncontrolled infective diseases.
- Ongoing therapy with corticosteroids greater than 20 mg of prednisone or its equivalent per day and the duration of treatment was more than 14 days.
- Concomitant medications that are strong CYP3A4 inhibitors or strong inducers within 7 days prior to the first dose. Avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids...
- Major surgery within 4 weeks prior to study entry or surgery is under schedule in the short run.
- Pregnant or breast-feeding female.
- Any uncontrolled intercurrent illness or condition that in the judgement of the investigator may endanger the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Guanzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guanzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.