Description:

COG AALL08B1 OPEN Registration Worksheet NCT01142427 Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ADF3C25C-AD44-CFB2-E040-BB89AD4343C8

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ADF3C25C-AD44-CFB2-E040-BB89AD4343C8
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  1. 12/18/14 12/18/14 - Martin Dugas
  2. 9/24/15 9/24/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Registration Leukemia COG AALL08B1 NCT01142427

No Instruction available.

  1. StudyEvent: COG AALL08B1 OPEN Registration Worksheet
    1. No Instruction available.
Stratification
ADVL0912 Stratum
Patient Criteria
Does the patient have newly diagnosed acute leukemia suspected to be acute lymphoblastic leukemia (See Section 3.2.3 for eligibility requirements)
Did patient have a bone marrow evaluation just prior to study entry (See section 3.2 and 3.2.1 for eligibility requirements)
Was the patient in the indicated age range at time of study enrollment (To be eligible, patient must be greater than 12 months and less than or equal to 21 years of age at the time of study enrollment.)
Will all required diagnostic samples be sent to the local and COG Reference Laboratories as per indicated documents (Indicated documents include Appendix I-V. Adequate samples MUST be sent to a COG-APPROVED Cytogenetic Laboratory and COG Reference Laboratory per Section 4.1 so that the data needed for risk-adjusted post-Induction therapy are available)
Has the patient received Prior Treatment with cytotoxic chemotherapy (Patients may not have received prior cytotoxic therapy except for intrathecal chemotherapy or steroids See sections 3.2.6 and 3.3.1. PATIENTS MUST BE ENROLLED ON AALL08B1 BEFORE TREATMENT BEGINS with the exception of the first dose of intrathecal chemotherapy or selected cases of steroid pretreatment)
Does patient have the indicated type of leukemia (Indicated type of leukemia is secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy)
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must be met)
Consent For Research Studies
Was consent signed for Pharmacokinetics
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
Patient consents to tissue submission
Patient consents to blood submission
Exclusion Criteria
Pregnancy test done
Is patient pregnant
Is patient nursing
Has patient agreed to use an effective contraceptive method
Is the patient receiving corticosteroids?
Has patient been on a stable or decreasing dose of corticosteroids for the indicated period
Is patient currently receiving any other anticancer or experimental drug therapy
Does patient have an uncontrolled infection?
Is patient, in the opinion of the investigator, able to comply with the safety monitoring requirements of the study
Is patient receiving CYP3A4 substrates with narrow therapeutic indices
Did patient receive CYP3A4 inhibitor during the indicated period
Did patient receive CYP3A4 inducer during the indicated period
Organ Function - Non Hematological
Does patient have adequate renal function?
mg/dL
mL/Min/1.73m2
Does patient have adequate liver function?
mg/dL
mg/dL
U/L
g/dL
Is patient able to swallow capsules or a liquid suspension
Organ Function - Hematological
Does patient have bone marrow involvement
Does patient have adequate bone marrow function?
/ul
1000/ul
%
%
1000/uL
g/dL
Were transfusions given
Inclusion Criteria
Were tests to determine eligibility performed during the indicated period
Does patient have a BSA (body surface area) greater than or equal to the indicated value (BSA Dose Level 0 and 1 only: To be eligible, patients must have a BSA >= 0.4 at the time of study enrollment. - )
Does patient have histologic verification of the malignancy at the indicated time point
Does patient have neuroblastoma
Does patient have ALCL (anaplastic large cell lymphoma)
Does patient have histologic verification of the malignancy at the indicated time point
Did patient have ALK molecular abnormality verified by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
Does patient have histologic verification of the malignancy at the indicated time point
Does patient meet the disease status requirement (To be eligible, patient must have either measurable and/or evaluable disease. - - Note: See Protocol Sections 12.2 and 12.3 and 12.6 for definitions.)
Is patient's current disease state one for which there is no known curative therapy available or therapy proven to prolong survival with an acceptable quality of life
Karnofsky Status
Lansky
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Prior therapy type
Did patient receive nitrosourea
Has patient previously received any of the indicated agents (To be eligible, patients must not have received prior therapy with PF-02341066.)
Stratification
AALL08B1 Stratum
Consent For Research Studies
Did patient or parent agree to allow the indicated specimen(s) to be banked for future scientific research related to this protocol (Indicated specimens include bone marrow and peripheral blood Instruction # 1 - research on genetic variation - model consent)
Has the patient given permission for optional sample banking for future cancer research studies (Instruction # 2 - model consent)
Did patient/parent/guardian agree to have patients' specimen banked for use in research to learn about, prevent, or treat cancer (Instruction # 3 - model consent)
Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer (Instruction # 4 - model consent)

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