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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT01712659
Eligibility Criteria:
* INCLUSION CRITERIA:
NOTE: After approval and activation of Amendment D, subjects who have failed this protocol treatment previously at the initial dose level may be eligible for re-enrollment and retreatment if they otherwise meet eligibility criteria.
* Subjects greater than or equal to 18 years old with pathologically confirmed adult T- cell leukemia: smoldering or chronic, or previously treated lymphomatous or acute subtypes with clinically indolent behavior indicated by lack of significant symptoms and treatment free interval of greater than 6 months are eligible for treatment in the dose escalation and expansion cohorts.
* Subjects must have serum antibodies directed to human T-cell lymphotropic virus type 1 (HTLV-1).
* Subjects must have measurable or evaluable disease. Subjects with \> 10% of the peripheral blood mononuclear cells (PBMCs) having the characteristic abnormal (i.e., CD3dim, cluster of differentiation 4 (CD4) plus cluster of differentiation 25 (CD25) plus expressing) fluorescence-activated cell sorting (FACS) profile for circulating adult T-cell leukemia (ATL) cells will be considered to have evaluable disease.
* Subjects must have adequate physiologic parameters:
* Absolute granulocyte count greater than or equal to 500 K/microL, platelet count greater than or equal to 75,000 K/microL and hemoglobin greater than or equal to 10 g/dL.
* Bilirubin and creatinine less than or equal to 1.5 times institutional upper limit of normal (ULN).
* Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) less than or equal to 3.0 times institutional ULN.
* Karnofsky Performance Score greater than or equal to 70% or Eastern Cooperative Oncology Group (ECOG) less than or equal 1.
* Subjects must be able to understand and sign Informed Consent Form.
EXCLUSION CRITERIA:
* Subjects with symptomatic leukemic meningitis, bony or gastrointestinal (GI) tract involvement, serum calcium or lactate dehydrogenase (LDH) \> 1.5 times the upper limit of normal will be excluded. However, subjects that have both ATL and another HTLV-1 associated disease such as tropical spastic paraparesis (human T-cell lymphotropic virus type 1 (HTLV-1) Associated Myelopathy (HAM)/tropical spastic paraparesis (TSP) will be included.
* Subjects with symptomatic leukemic meningitis, bony or GI tract involvement, serum calcium or LDH \> 1.5 X the upper limit of normal will be excluded. However, subjects that have both ATL and another HTLV-1 associated disease such as tropical spastic paraparesis (HAM/TSP) will be included.
* Subjects who have received high doses of systemic corticosteroids for the treatment of their ATL within 4 weeks prior to the start of therapy.
* Subjects who have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study.
* Life expectancy of less than 3 months.
* Documented active bacterial infections, HTLV-II infection, or hepatitis B or C as follows:
* A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antigen (HBsAb) positive and hepatitis B core antibody (HBcAb) negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion.
* Subjects with an indolent chronic hepatitis B infection (normal ALT, AST, albumin and no radiographic or biopsy evidence of cirrhosis) may be eligible.
* Subjects with active hepatitis C are excluded. Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
* Subjects who have untreated human immunodeficiency virus (HIV) are not eligible for this study because by definition they have a defective immune response and are at much higher risk for opportunistic infections due to immune disregulation by both HTLV-1 and HTLVIII (HIV) viruses. Subjects on HIV therapy with undetectable viral loads as measured by HIV RNA quantitative real time PCR may be eligible.
* Inability or refusal to practice effective contraception during therapy. Men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 1 week after completion of the treatment.
* Subject has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders or significant psychological conditions at baseline visit that in the investigators judgment would jeopardize subject enrollment or compliance with the study procedures.
* Subjects with an absolute requirement for a medication that is a strong inhibitor of Cytochrome P450 3A4 (P450 CYP3A4) are not eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01712659
Study Brief:
Protocol Section:
NCT01712659