Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants Wit… (NCT04607772) | Clinical Trial Compass
WithdrawnPhase 1/2
Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)
Stopped: Sponsor decision
United States0Started 2020-11-18
Plain-language summary
This is a Phase 1/2, multicenter, open-label study to evaluate the efficacy, and safety of various combinations with selinexor in participants with RR DLBCL. The study will be conducted in two phases: Phase 1 and 2. The Phase 1 of the study will be a standard 3 + 3 dose escalation to determine the maximal tolerated dose (MTD), recommended Phase 2 dose (RP2D) for each treatment arm, and assess the dose limiting toxicities (DLTs). The Phase 2 of the study will be a dose expansion study to assess the efficacy and safety of for RP2D selected at the end of Phase 1 of the study for each treatment arm.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants greater than or equal to (≥) 18 years of age.
✓. Have pathologically confirmed relapsed/refractory (RR) DLBCL, not otherwise specified (NOS).
✓. Participants with High Grade B-cell Lymphoma (HGBL) are allowed in Phase 2 only.
✓. Prior lines of systemic therapy for the treatment of DLBCL:
✓. Positron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than (\>) 1.5 centimetres (cm) or 1 extranodal lesion with LDi \>1 cm.
✓. Adequate bone marrow function at Screening.
✓. Circulating lymphocytes less than or equal to (≤) 50 \* 109/L.
✓. Adequate liver and kidney function.
Exclusion criteria
✕. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma.
What they're measuring
1
Phase 1: Maximum Tolerated Dose (MTD)
Timeframe: Within the first cycle (maximum 28 days) of treatment
2
Phase 1: Recommended Phase 2 Dose (RP2D)
Timeframe: Up to 6 cycles (up to 6 months) of treatment
3
Phase 2: Overall Response Rate (ORR) per the Lugano Classification 2014
Timeframe: Cycle 1 Day 1 (each cycle consists of maximum 28 days) until a complete response (CR) or partial response (PR) (up to 6 months)
✕. Previous treatment with selinexor or other XPO1 inhibitors.
✕. Contraindication to any drug contained in the different treatment arms.
✕. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \<21 days prior to Cycle 1 Day 1 (C1D1). Low dose steroids \<30 mg prednisone (or equivalent) and palliative radiotherapy are permitted.
✕. Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or strong CYP3A inducers ≤14 days prior to Day 1 dosing.
✕. Any AE, by Cycle 1 Day 1 (C1D1), which has not recovered to Grade ≤1 (CTCAE, v. 5.0), or returned to baseline, related to the previous DLBCL therapy, except alopecia.
✕. Major surgery \<14 days of C1D1.
✕. Autologous stem cell transplant (SCT) \<100 days or allogeneic SCT \<180 days prior to C1D1 or active graft-versus-host disease after allogeneic SCT (or cannot discontinue graft versus host disease \[GVHD\] treatment or prophylaxis).