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



Status:Terminated
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 21
Updated:4/21/2016
Start Date:June 2010

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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

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.


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.
We found this trial at
27
sites
Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Atlanta, GA
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Boston, Massachusetts
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Brisbane, Queensland
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Charlotte, NC
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Chicago, Illinois 60611
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Cleveland, Ohio
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Dallas, Texas 75390
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Fort Worth, Texas 76104
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Kansas City, Missouri 64108
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Memphis, Tennessee 38105
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Miami, Florida 33136
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55404
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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New York, New York 10021
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Salt Lake City, Utah 84132
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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