A Study of ATG-010 in Combination With Lenalidomide and Rituximab (R2) in Adults With DLBCL and iNHL (NCT05265975) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of ATG-010 in Combination With Lenalidomide and Rituximab (R2) in Adults With DLBCL and iNHL
Stopped: The adjustment of the sponsor's research and development strategy
China54 participantsStarted 2022-04-07
Plain-language summary
A Single-arm, Phase â… /â…¡ Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ATG-010 in Combination with Lenalidomide and Rituximab (R2) in Adult Patients with Relapsed/Refractory DLBCL and iNHL Who are Ineligible for High-dose Chemotherapy (HDC) or Autologous Stem Cell Transplant (A SCT).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Pathologically confirmed DLBCL (including de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma \[e.g., follicular lymphoma\]) or B-cell iNHL with histological subtype limited to FL Grade 1, Grade 2, or Grade 3a or nodal or extranodal marginal zone lymphoma (MZL), based on criteria established by the World Health Organization (WHO) 2016 classification.
✓. Received at least 1 line of systemic therapy for the treatment of B-NHL.
✓. Have evidence of relapse or refractory disease.
✓. At least one bi-dimensionally measurable lesion per the Lugano 2014 Criteria (Cheson, 2014; Appendix 4).
✓. Adequate bone marrow function at screening, defined as:
✓. Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN);
✓. Serum total bilirubin ≤1.5 × ULN, or ≤3 ULN if have Gilbert syndrome;
. DLBCL with MALT lymphoma; composite lymphoma (Hodgkin's lymphoma+NHL); primary mediastinal (thymic) large B-cell lymphoma; Grade 3b follicular lymphoma.
✕. Dose Escalation Phase: Subjects with known central nervous system involvement. Dose Expansion Phanse: Subjects with advanced lymphoma of the central nervous system involvement at screening, however, subjects have stable central nervous system lymphoma (in the case of no intracranial pressure or other conditions need medical intervention) or do not occur disease progression as assessed by neurological symptoms, signs, and radiography within 28 days prior to C1D1, will be considered eligible.
✕. Previous treatment with ATG-010 (selinexor) or other XPO1 inhibitors, or prior exposure to lenalidomide within 3 months before C1D1.
✕. Contraindication to any drug in the combination therapy of SR2.
✕. Use of any standard or experimental anti B-NHL therapy \<21 days prior to C1D1, including chemotherapy, immunotherapy, radio-immunotherapy, nonpalliative radiation, or any other anticancer therapy.
✕. Major surgery, or live vaccines received \<28 days prior to C1D1.
✕. ASCT \<6 months or CAR-T cell infusion \<6 months prior to the screening.
✕. History of allogeneic hematopoietic stem cell transplant.