A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC
Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Nelarabine
- drug : Etoposide
- drug : Filgrastim
- drug : Methotrexate
- drug : Cyclophosphamide
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- Patients to be enrolled in the dose-escalation portion of this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL or T-LL). Patients to be enrolled in the cohort expansion portion of this study (ie, those treated at the recommended phase 2 dose) must have T-cell ALL in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL). T-LL patients are not eligible for the cohort expansion phase. - Patients with T-cell ALL must have greater than 25% blasts in the bone marrow with or without extramedullary disease. - Patients with T-cell LL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis. Patients with T-cell LL enrolled in the phase I dose-escalation study are not required to have measurable disease; however, patients enrolled in the phase II cohort expansion at the MTD must have measurable disease. - Patients may have CNS 1 or CNS 2 disease but not CNS 3. - ECOG 0-2 or Karnofsky ? 50% for patients > 16 years of age; Lansky ? 50% for patients ?16 years of age. - Patients may be enrolled on study regardless of the timing of prior Intrathecal therapy; however, they MAY NOT BEGIN TREATMENT ON THIS PROTOCOL UNTIL A MINIMUM OF 7 DAYS HAS ELAPSED SINCE PRIOR INTRATHECAL THERAPY. - At least 6 weeks must have elapsed since administration of nitrosureas. - At least 12 weeks must have elapsed since administration of craniospinal or hemipelvic radiation. - Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment. - Female patients with infants must agree not to breastfeed their infants while on this study. - Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment. - 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. - No evidence of dyspnea at rest - No exercise intolerance - A pulse oximetry ? 94% at sea level (? 90% at altitude ? 5000 feet) if there is clinical indication for determination. - Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent.