A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC - NECTAR trial

TAC0 个研究点目标入组 36 人开始时间: 2015年1月7日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•-Patients must be =1 and <18 years of age at the time of study enrollment (adpated for the NL)
•-Patients must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in first relapse or must have failed primary induction chemotherapy
•- ECOG 0-2 or Karnofsky = 50% for patients > 16 years of age; Lansky = 50% for patients =16 years of age. (See Appendix II for Performance Scales)
•- Adequate renal function defined as serum creatinine = 1.5x upper limit of normal (ULN) for age. If the serum creatinine is above these values, the calculated creatinine clearance or radioisotope GFR must be = 70 mL/min/1.73m2.
•- Total bilirubin = 1.5x ULN for age.
•- If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin = ULN for age.
•- ALT = 5x ULN of normal for age.
•- Adequate cardiac function defined as shortening fraction of = 27% by echocardiogram or ejection fraction = 45% by gated radionuclide study.
•- Patients must have adequate pulmonary function
•- All patients and/or their parents or legal guardians must sign a written informed consent.
•-Patients covered by a Health Insurance System
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 36
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients are excluded if they have CNS 3 disease
•- Patients with Down syndrome are excluded.
•- Patients with pre-existing Grade 2 (or greater) peripheral motor or sensory neurotoxicity per the CTCAE 3.0 as determined by the treating physician or a neurologist.
•- Patients with a history of prior veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) or findings consistent with a diagnosis of VOD/SOS
•- Patients are excluded if they have had
•-Previous hematopoietic stem cell transplantation;
•-Patients with a prior seizure disorder requiring anti-convulsants
•- Patients are excluded if they have:
•Positive blood culture within 48 hours of study enrollment;
•Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection
•- Plan to administer non-protocol chemotherapy, radiation therapy, immunotherapy, or any other investigational agents during the study period.

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