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

Children's Hopsital Los Angeles0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月29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 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.

发起方

Children's Hopsital Los Angeles