Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT03552692
Eligibility Criteria:
Inclusion criteria:
* Histologically documented diagnosis of BCL-2 positive PTCL-NOS, AITL, TFH as defined in the 2016 edition of the World Health Organization (WHO) classification. Only patients with percentage of BCL-2 positive tu-mor cells ≥ 25% in the relapse biopsy, if available, or otherwise in the ini-tial biopsy, will be included onto the study;
* Age ≥ 18 years
* Relapsed or refractory to at least one previous standard line of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
* At least one site of measurable nodal or extranodal disease at baseline ≥ 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan cannot be performed). Note: Patients with only bone marrow involvement are eligible
* Adequate hematological counts defined as follows:
* Absolute Neutrophil count (ANC) \> 1.0 x 10\^9/L unless due to bone marrow involvement by lymphoma
* Platelet count ≥ 50.000/mm\^3 unless due to bone marrow involvement by lymphoma
* Adequate renal function defined as follows:
* Creatinine clearance ≥ 30 mL/min
* Adequate hepatic function per local laboratory reference range as follows:
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN
* Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syn-drome or of non-hepatic origin)
* Subject understands and voluntarily signs an informed consent form ap-proved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific pro-cedures
* Subject must be able to adhere to the study visit schedule and other pro-tocol requirements
* Subject must be able to swallow capsules or tablets
* Life expectancy ≥ 3 months
* Women must be:
* postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
* surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
* completely abstinent (periodic abstinence from intercourse is not per-mitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injec-tions, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, be-fore entry, and must agree to continue to use the same method of con-traception throughout the study. They must also be prepared to contin-ue birth control measures for at least 1 month after terminating treat-ment.
* women of childbearing potential must have a negative pregnancy test at screening
* Men must agree to use an acceptable method of contraception (fort themselves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 1 month after receiving the last dose of study drug.
Male even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following:
* practice effective barrier contraception during the entire study treatment period and through 1 months after the last dose of study drug, or
* agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods for the female part-ner\] and withdrawal are not acceptable methods of contraception)
Exclusion criteria
* Histological diagnosis different from BCL-2 positive PTCL-NOS, AITL, and TFH
* Allogeneic or autologous stem cell transplant within 6 months prior to the informed consent signature
* Treatment with any of the following within 7 days prior to the first dose of study drug:
* steroid therapy for anti-neoplastic intent
* moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Ap-pendix C for examples)
* moderate or strong CYP3A inducers (see Appendix C for examples)
* Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug
* History of CNS involvement by lymphoma
* Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
* grapefruit or grapefruit products
* Seville oranges (including marmalade containing Seville oranges)
* star fruit
* Previous treatment with a BCL-2 family protein inhibitor
* Subject is known to be positive for HIV (HIV testing is not required)
* Cardiovascular disease (NYHA class ≥2)
* Creatinine Clearance \< 30 mL/min
* Significant history of neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.
* Any history of other active malignancies within 3 years prior to study en-try, with the exception of adequately treated in situ carcinoma of the cer-vix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically re-sected with curative intent.
* Subject who has malabsorption syndrome or other condition which pre-cludes enteral route of administration.
* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bac-terial or fungal)
* Active HBV positive hepatitis
* The following categories of patients HBV positive but with non evidence of active hepatitis may be considered for the study:
* HBsAg positive with HBV DNA \< 2000 UI/ml (inactive carriers); HBV DNA \> 2000 UI/ml is criteria of exclusion
* HBsAg negative but HBsAb positive
* HBsAg negative but HBcAb positive
* Patients HBsAg positive with HBV DNA \< 2000 UI/ml and HBsAg nega-tive but HBcAb positive will be eligible for the study only if they accept to receive prophylactic Lamivudine 100 mg/daily for all the period of treatment and at least for 12 months after the end of therapy. Treatment with ABT-199 should be stopped in case of hepatitis reactivation.
* Active HCV positive hepatitis
* If female, the patient is pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03552692
Study Brief:
Protocol Section:
NCT03552692