KPT-330 Plus RICE for Relapsed/Refractory Aggressive B-Cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the addition of selinexor (KPT-330) to RICE chemotherapy in the treatment of relapsed and refractory aggressive B-Cell Lymphoma, with the goal of improved response rates (as compared to RICE chemotherapy alone).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborators: FDA Office of Orphan Products Development; Karyopharm Therapeutics Inc; Karyopharm Therapeutics, Inc; The Leukemia and Lymphoma Society
• Treatments: BB 1101; Carboplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Rituximab

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed aggressive B-cell non-Hodgkin lymphomas:

• DLBCL including ABC, GCB or PMBCL subtypes

• Double/triple hit lymphomas

• Indolent lymphomas transformed to aggressive lymphomas

• Follicular lymphomas grade 3B

• Patients must have received at least two cycles of anthracycline based chemotherapy administered with curative intent and one of the following:

• failed to have achieve at least a partial response after 2 or more cycles

• failed to achieve a complete response after 6 or more cycles

• progressed after an initial response

• Patients must be age ≥18 years.

• Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.

• Patients must have ECOG performance status of 0-2.

• Patients must have laboratory test results within these ranges:

• Absolute neutrophil count ≥ 1500/mm³

• Platelet count ≥ 100,000/mm³

• Serum creatinine clearance ≥40 mL/min

• Total bilirubin ≤ 1.5x ULN. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.

• AST (SGOT) and ALT (SGPT) ≤ 2x ULN

• Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to selinexor treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.

• Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal.

• For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.

• Patients must be able to understand and willing to sign a written informed consent document.

• Patients must be able to adhere to the study visit schedule and other protocol requirements.

• Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

• Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

Exclusion Criteria:

• Patients with hyperuricemia or other potential signs of tumor lysis syndrome

• Patients with more than minimally symptomatic disease (i.e. > grade 1), high tumor burden, or other indication for urgent treatment.

• Patients who have had prior malignancies (other than B-cell lymphomas) for ≤5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.

• Patients who have had other anti-cancer therapy, including radiation or experimental drug or therapy, within 28 days of enrollment.

• Patients with known HIV, active hepatitis B, active hepatitis C.

• Patients with known central nervous system involvement by lymphoma.