Ensayos clínicos

FOR SCREENING PHASE:

Inclusion Criteria:

1. Diagnosis of extranodal NK/T lymphoma, perWHO classification, 4th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP1 immunostaining.
2. a) Clinically suspected or documented relapse/progression, at any time following at least one cycle of an asparaginase-based chemotherapy OR b) High-risk disease (stage III/IV, KPI groups 3-4 or IPI intermediate-high) at any time (regardless of chemotherapy status and disease relapse/ progression)
3. Male or female ≥ 18 years of age.
4. Weigh ≥ 35 kg.
5. ECOG performance score 0-2, inclusively.
6. Negative β-hCG test in women of childbearing potential.
7. Able to understand and comply with the requirements of the study and to provide written informed consent.

Exclusion Criteria:

1. CNS lymphoma.
2. NK cell leukemia.
3. Hemophagocytic lymphohistiocytosis.
4. Positive laboratory test for anti-HIV 1,2; HBsAg, anti-HTLV-I; anti-HCV, or syphilis (Patients with anti-hepatitis B core antibody are eligible if negative for HBsAg).
5. Use of systemic corticosteroids >0.5 mg/kg/day within 10 days prior to obtaining 100 mL whole blood starting material.
6. Patient is pregnant or lactating.
7. Female patient of childbearing potential unwilling to use effective birth control.
8. Sexually active patients unwilling to utilize one of the more effective birth control methods during the study and for 6 months after the study treatment is concluded. The male partner should use a condom.
9. Clinically significant medical condition e.g. pulmonary, neurological, cardiovascular, metabolic, that could jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.
10. Active second malignancy.
11. Previous non-hematological malignancy, except for adequately treated basal-cell carcinoma of skin or cervical carcinoma in-situ without current evidence of disease, unless the tumor was treated with curative intent more than 5 years prior to study entry.
12. Any prior allogeneic hematopoietic stem cell or solid organ transplant.

FOR TREATMENT PHASE:

Inclusion Criteria:

1. All Screening Phase inclusion criteria.
2. Documented relapse or progression following at least one prior cycle of an asparaginase-containing chemotherapy regimen.
3. At least one prior cycle of gemcitabine-based salvage chemotherapy.
4. Completed most recent course of chemotherapy at least 2 weeks prior to first study drug dose.
5. Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0.
6. Life expectancy ≥ 8 weeks.
7. Pulse oximetry of ≥ 90% on room air.

Exclusion Criteria:

1. All Screening Phase exclusion criteria.
2. Use of any investigational agents within prior 4 weeks.
3. Radiotherapy within prior 3 weeks.
4. Major surgery within prior 2 weeks.
5. Systemic corticosteroids within 24 hours prior to study drug administration.
6. Symptoms of cardiac failure with New York Heart Association classification of III or IV.
7. Clinically significant medical condition e.g. infection, pulmonary, neurological, cardiovascular, metabolic, that could jeopardize patient safety, interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator.