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Clinical Trials (PDQ®)

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITreatmentActive1 to 21OtherT2008-002
NCT00981799

Trial Description

Summary

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Therapeutic Advances in Childhood Leukemia Consortium

GlaxoSmithkline

Jim Whitlock, MDStudy Chair

Jeannette van der Giessen, BAPh: 323-361-8725
  Email: jvandergiessen@chla.usc.edu

Trial Sites

U.S.A.
California
  Los Angeles
 Children's Hospital Los Angeles
 Paul S. GaynonPrincipal Investigator
  Orange
 Children's Hospital of Orange County
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Steven DuBoisPrincipal Investigator
Colorado
  Aurora
 Children's Hospital Colorado Center for Cancer and Blood Disorders
 Lia GorePrincipal Investigator
District of Columbia
  Washington
 Children's National Medical Center
Florida
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 John Goldberg, MDPrincipal Investigator
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
Illinois
  Chicago
 Ann and Robert H. Lurie Children's Hospital of Chicago
 Nobuko Hijiya, MDPrincipal Investigator
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Michigan
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Raymond J. HutchinsonPrincipal Investigator
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Bruce C. BostromPrincipal Investigator
 Yoav MessingerPrincipal Investigator
Missouri
  Kansas City
 Children's Mercy Hospital
 Kathleen Neville, MDPrincipal Investigator
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Julia L. Glade-BenderPrincipal Investigator
 NYU Cancer Institute at New York University Medical Center
 Elizabeth A. RaetzPrincipal Investigator
North Carolina
  Charlotte
 Levine Children's Hospital
 Javier Oesterheld, MD
 Javier Oesterheld, MDPrincipal Investigator
Ohio
  Cleveland
 Rainbow Babies
 Joe Matloub, MD
  Columbus
 Nationwide Children's Hospital
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
Tennessee
  Memphis
 St. Jude Children's Research Hospital
 Deepa Bhojwani, MD
  Nashville
 Vanderbilt Children's Hospital
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  Fort Worth
 Cook Children's Hospital
 Ken Heym, MD
Utah
  Salt Lake City
 Primary Children's
 Elizabeth Raetz, MD
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Blythe Thompson, MDPrincipal Investigator
Wisconsin
  Milwaukee
 Medical College of Wisconsin Cancer Center
 Mike Burke, MD
Australia
  Sydney
 New Childrens Hospital
  Westmead, NSW
 Children's Hospital at Westmead
Queensland
  Brisbane
 Royal Children's Hospital
Victoria
  Melbourne
 Royal Children's Hospital, Melbourne
Austria
  Vienna
 St. Anna Children's Hospital
 Andische Attarbaschi, MD, PhD
Canada
  Vancouver
 Children's and Women's Hospital of British Columbia
Ontario
  Toronto
 SickKids Foundation
Quebec
  Montreal
 Sainte Justine University Hospital
 Henrique Bittencourt, MD
France
  Lille
 CHU Lille
 Brigitte Nelken, MD, Phd
Italy
  Rome
 Bambino Gesù Hospital
 Franco Locatelli, MD, PhD
Netherlands
  Rotterdam
 Erasmus MC - Sophia
 Michel Zwaan, MD, PhD

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00981799
ClinicalTrials.gov processed this data on December 04, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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