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


Phase 1/Phase 2
1 Year
21 Years
Open (Enrolling)
Both
Relapsed T-Cell Acute Lymphoblastic Leukemia, Relapsed T-Cell Lymphoblastic Lymphoma

Thank you

Trial Information

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


Inclusion Criteria:



- Patients must have first relapse T-cell ALL or T-cell lymphoblastic lymphoma.

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated doses and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jim Whitlock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children

Authority:

United States: Institutional Review Board

Study ID:

T2008-002

NCT ID:

NCT00981799

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Relapsed T-Cell Acute Lymphoblastic Leukemia
  • Relapsed T-Cell Lymphoblastic Lymphoma
  • Relapse
  • T cell
  • Lymphoblastic
  • Leukemia
  • Lymphoma
  • Nelarabine
  • TACL
  • NECTAR
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Stanford University Medical CenterStanford, California  94305-5408
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Childrens Hospital Los AngelesLos Angeles, California  90027
Vanderbilt Children's HospitalNashville, Tennessee  37232-6310
City of HopeDuarte, California  91010
New York University Medical CenterNew York, New York  10016
Oregon Health and Science UniversityPortland, Oregon  97201
Seattle Children's HospitalSeattle, Washington  98105
Dana FarberBoston, Massachusetts  02115-6084
UCSF School of MedicineSan Francisco, California  94143-0106
University of Miami Cancer CenterMiami, Florida  33136
C.S. Mott Children's HospitalAnn Arbor, Michigan  48109-0914
Childrens Hospital & Clinics of MinnesotaMinneapolis, Minnesota  55404-4597
Children's Hospital New York-PresbyterianNew York, New York  10032
Miller Children's HospitalLong Beach, California  90806
Children's MemorialChicago, Illinois  60614
Oakland Children's HospitalOakland, California  
University of Minnesota Children's HospitalMinneapolis, Minnesota  
Nationwide Childrens HospitalColumbus, Ohio  
Levine Children's Hospital at Carolinas Medical CenterCharlotte, North Carolina  28203
Children's Healthcare of Atlanta, Emory UniversityAtlanta, Georgia  
St. JudeMemphis, Tennessee  38105-3678