NCT04298879CompletedPhase 2
IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Source: ClinicalTrials.gov · Last updated 5 Jun 2024
Brief summary (registry, in English)
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- First submitted
- 2 Mar 2020
- Start date
- 7 Apr 2020
- Primary completion date
- 27 Jul 2021
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Follicular lymphoma
- NCT number
- NCT04298879
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 81
- From 7 Apr 2020 to the primary completion date, 27 Jul 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
- 4\. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- 5\. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
Other illness
- 2\. History of central nervous system lymphoma (either primary or metastatic).
- 6\. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Other
- 1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
Who the study is looking for
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
- Ineligible for hematopoietic stem cell transplant.
- Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- ECOG performance status 0 to 2.
- Life expectancy ≥ 12 weeks.
- Adequate hematologic, hepatic, and renal function.
- Willingness to avoid pregnancy or fathering children.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital, school of medicine, Shanghai jiao tong university Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.