A Phase III Randomized Trial for Newly Diagnoised High Risk B-Lymphoblastic Leukemia (B-ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum

Phase 1

• Conditions: Acute Lymphoblastic Leukemia; MedDRA version: 18.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001866-90-IE
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-15
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4895

Inclusion Criteria

•Patients must be enrolled on AALL08B1 prior to enrollment on AALL1131.
•Age
Patients must be > 365 days and < 31 years of age
3.2.3 White Blood Cell Count (WBC) Criteria
Age 1-9.99 years: WBC = 50 000/µL
Age 10-30.99 years: Any WBC
Age 1-30.99 years: Any WBC with:
a) Testicular leukemia
b) CNS leukemia (CNS3)
c) Steroid pretreatment (see Section 3.3 )

•Diagnosis
Patients must have newly diagnosed B lymphoblastic leukemia (2008 WHO classification) (also termed B-precursor acute lymphoblastic leukemia). Patients with Down syndrome are also eligible.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131. Patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxi chemotherapy.Patients receiving prior steroid therapy may be eligible for AALL1131
• Patients with BCR-ABL1 fusion (not eligible for post-Induction therapy on this study; non-DS patients may be eligible to enroll in AALL1122 or successor COG Ph+ ALL trial by Day 15 Induction)
• DS HR B-ALL patients with Induction failure or BCR-ABL1
• Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs.
• Lactating females are not eligible unless they have agreed not to breastfeed their infant.
• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.
• Eligibility criteria for the Incidence and Natural History of Osteonecrosis study
A) Patients must be 10 years of age or greater at the time of B-ALL diagnosis, enrolled on AALL1131.
B) Patients with Down syndrome are not eligible

• Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study
A)Patients must be aged 6 to 11 years at time of B-ALL diagnosis, enrolled on AALL1131
B) Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available)
C) Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William‘s Syndrome, mental retardation)
D) Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli

• Eligibility criteria for the NCI standard risk patients from AALL0932 enrolling on this study at the end of Induction. - Patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the HR B-ALL stratum of this study at the end of Induction: a) Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with Day 8 PB MRD = 1% and Day 29 BM MRD < 0.01%. b) With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any Day 8 PB MRD and Day 29 BM MRD > 0.01%. Both NCI SR and HR patients without Down syndrome and with testicular disease at diagnosis, who do not meet other VHR criteria, will be eligible for the HR stratum.

• Patients enrolled on AALL0932, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the VHR B-ALL stratum of this study at the end of Induction: a) iAMP21 b) MLL rearrangement c) Hypodiploidy (n< 44 chromosomes and/or a DNA index < 0.81) d) Induction Failure (M3 BM at Day 29) e) Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with Day 29 BM MRD > 0.01%

• Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified