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.

Lead Sponsor:

Therapeutic Advances in Childhood Leukemia Consortium

Collaborator: Novartis

Intervention(s):

  • Drug: Nelarabine
  • Drug: Etoposide
  • Drug: Cyclophosphamide
  • Drug: Methotrexate
  • Drug: Filgrastim

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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) 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting