ANHL01P1: Eligibility Worksheet Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Source Form: NCI FormBuilder:

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Drug/Agent Toxicity by Tissue/Organ NCT00057811 Eligibility - ANHL01P1: Eligibility Worksheet - 2091107v3.0

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  1. StudyEvent: ANHL01P1: Eligibility Worksheet
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Does patient have newly diagnosed mature (CD20 positive) high-grade B-lineage lymphoma, i.e. diffuse large B-Cell Lymphoma, Burkitt's lymphoma or Burkitt's-like lymphoma? (Answer must be yes. If answer is 'no', terminate registration process.)
Does patient have pre-cursor B-cell lymphoblastic lymphoma? (Answer must be no. If answer is 'yes', terminate registration process.)
Is patient >= 1 year and <30 years at study enrollment? (Answer must be yes. If answer is 'no', terminate registration process.)
Did patient receive any previous chemotherapy prior to registration? (Answer must be no. If yes, terminate registration process.)
Did patient receive emergency irradiation and/or steroid therapy, prior to registration? (If yes, the following 3 questions must be answered.)
Will the patient start protocol therapy within 72 hours of emergency treatment? (Only required if patient received emergency treatment. Then the answer must be yes, or the registration process must be terminated.)
Were steroids given? (Can be yes or no)
were bone marrow and CSF exams obtained prior to steroids? (Required only if answer to question above is yes. Must be yes or N/A. If no, terminate registration process.)
Did the patient receive corticosteroids for more than 10 days and/or the patient receive corticosteroids within 8 days from diagnosis and initial work-up?
Did the patient receive any steroids, other than corticosteroids, in the week prior to diagnosis? (To be eligible, patient must not have received any steroids except in emergency situation, as noted above 8 days prior to diagnosis.)
Karnofsky Performance Score (For patients greater than 10 years of age)
Lansky Play Score (For patients less than or equal to 10 years of age)
Has patient had any prior solid organ transplantation? (Must be no. If yes, terminate registration process.)
Does patient have G6PD deficiency? (Can be yes or no)
Does patient have a congenital or acquired immune deficiency?
Murphy Stage (Institution must pick one.)
Therapy Stratification (If Group A is chosen, patient is not eligible, terminate registration process.)
was pregnancy test obtained? (If post-menarchal female,)
is patient pregnant and/or breastfeeding? (If post-menarchal female,)
has patient agreed to use contraceptive during protocol? (If patient is of reproductive potential,)
Have patient and/or their parents or legal guardians signed a written informed consent? (To be eligible, all patients and/or parents or legal guardians must have signed a written informed consent.)
Ccrr Module For Anhl01p1: Eligibility Worksheet

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