A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2021
• Main ID: NCT02741388
• Date of registration: 14/04/2016
• Prospective Registration: Yes
• Primary sponsor: The Lymphoma Academic Research Organisation
• Public title: A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP SELINDA
• Scientific title: A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP
• Date of first enrolment: October 2016
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02741388
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, France

Contacts

• Name: Hervé TILLY, MD
• Affiliation: Centre Henri Becquerel, Rouen, France - LYSA

• Name: Marie MAEREVOET, MD
• Affiliation: Institut Jules Bordet, Bruxelles, Belgium - LYSA

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with any type of relapsed or refractory B-cell lymphoma

2. Eligible to receive R-DHAOx or R-GDP regarding the investigator's opinion

3. Who received prior therapy with at least one but no more than two lines therapies for
B-Cell Lymphoma

4. Patient must have measurable disease defined by at least one single node or tumor
lesion > 1.5 cm

5. Aged between 18 years and 70 years (included) on date of consent signature

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

7. With a life expectancy of = 3 months

8. Having signed a written informed consent

9. Male patients (if sexually active with a woman of childbearing potential) must agree
to use a reliable method of birth control during the study treatment and for at least
6 months after the last study drug administration. Male patients must agree to not
donate sperm during the study treatment and for at least 6 months after the last study
drug administration

10. Female patients of childbearing potential must agree to use two reliable methods of
birth control during study treatment and for 6 months after the last dose and have a
negative serum human chorionic gonadotropin (hCG) pregnancy test within 3 days prior
to C1D1. Reliable methods of contraception include intrauterine devices, hormonal
contraceptives [contraceptive pills, implants, transdermal patches, hormonal vaginal
devices or injections with prolonged release], abstinence or sterilization of the
partner.

Exclusion Criteria:

1. Previous treatment with selinexor

2. Known central nervous system or meningeal involvement by lymphoma

3. Contraindication to any drug contained in these regimen

4. Subjects with known Human Immunodeficiency Virus (HIV) positivity

5. Subjects with known active Hepatitis B (HB) infection (positive Ag HBs) or positive
serology to hepatitis B (Ag HBs or antibody anti-HB c or positive DNA PCR) or active
Hepatitis C (HCV) infection (patients with positive HCV serology are eligible only if
PCR is negative for known HCV RNA)

6. Subjects with any uncontrolled active systemic infection requiring intravenous (IV)
antibiotics

7. Any of the following laboratory abnormalities within 14 days prior to first
administration (C1D1) of study treatment:

1. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L)

2. Spontaneous (within 7 days of any platelet transfusion) platelet count <
100,000/mm3 (100 x 109/L) (75 x 109/L if due to lymphoma)

3. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5.0 x upper
limit of normal (ULN)

4. Serum total bilirubin > 2x Upper Limit of Normal (ULN), or > 5x ULN if due to
Gilbert syndrome or lymphoma involvement

8. Creatinine clearance < 50 mL /min (for patients who will receive DHAOx) or < 70 mL/min
(for GDP)

9. Subjects with pre-existing = Grade 2 neuropathy

10. Prior history of malignancies other than lymphoma (except for basal cell or squamous
cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the
subject has been free of the disease for = 3 years

11. Any life-threatening illness, serious active disease or co-morbid medical condition,
laboratory abnormality, organ system dysfunction or psychiatric illness which, in the
investigator's opinion, could compromise the patient's safety, interfere with the
absorption or metabolism of selinexor, or put the study outcomes at undue risk, or
that would prevent the subject from signing the informed consent form

12. Pregnant or breastfeeding women

13. Use of any standard or experimental anti-cancer drug therapy within 28 days of the
initiation (Day 1) of study drug therapy (administration of glucocorticoids should not
exceed 1mg/kg/day in the 14 days prior to C1D1)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

B-cell Lymphoma

Intervention(s)

Drug: Cisplatin

Drug: Gemcitabine

Drug: Rituximab

Drug: selinexor

Drug: Cytarabine

Drug: Dexamethasone

Drug: Oxaliplatin

Primary Outcome(s)

Incidence rate of dose-limiting toxicities (DLTs) observed during the DLT assessment period (cycle 1) at each dose level examined [Time Frame: Up to 35 days]

Secondary Outcome(s)

Duration of response [Time Frame: 3 years]

Time to next anti-lymphoma treatment (TTNLT) [Time Frame: 3 years]

Incidence of grade = 2 renal toxicities, grade = 2 neuropathy, and grade = 3 toxicities [Time Frame: 3 months]

Progression-free survival (PFS) [Time Frame: 3 years]

Overall survival (OS) [Time Frame: 3 years]

Response rates [Time Frame: 3 months]

Secondary ID(s)

SELINDA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Karyopharm Therapeutics Inc