Trial Search Results
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
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 currently not accepting patients for this trial.
Therapeutic Advances in Childhood Leukemia Consortium
- Drug: Nelarabine
- Drug: Etoposide
- Drug: Cyclophosphamide
- Drug: Methotrexate
- Drug: Filgrastim
Phase 1/Phase 2
- 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
- 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
- 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
- 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.
- 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
- Patients with a history of prior veno-occlusive disease (VOD) or findings consistent
with a diagnosis of VOD, defined as: conjugated serum bilirubin >1.4 mg/dL AND
unexplained weight gain greater than 10% of baseline weight or ascites AND
hepatomegaly or right upper quadrant pain without another explanation, OR reversal of
portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy.
- Previous hematopoetic stem cell transplantation.
- Patients with a prior seizure disorder requiring anti-convulsant therapy are not
eligible to receive nelarabine. For the purposes of this study, this includes any
patient that has received anticonvulsant therapy to prevent/treat seizures in the
prior two years.
- 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, or immunotherapy
during the study period.
- Any significant concurrent disease, illness, psychiatric disorder or social issue that
would compromise patient safety or compliance, interfere with consent, study
participation, follow up, or interpretation of study results.
Ages Eligible for Study
1 Year - 21 Years
Genders Eligible for Study