Biomarkers to Classify Young Patients With Acute Lymphoblastic Leukemia (ALL) and Remission Induction Therapy in Young Patients With B-Precursor ALL

NCT01225874 | Completed DMC

• 5 other identifiers: 9900U10CA030969COG-9900POG-9900CDR0000078618
• Study Type: interventional
• Target: 3,762
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of blood or bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This trial is studying biomarkers to classify young patients with acute lymphoblastic leukemia (ALL) and remission induction therapy in young patients with B-precursor ALL.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia; non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (4)

• Collection of the clinical and laboratory data necessary for placing patients with acute lymphoblastic leukemia (ALL) onto the proper therapeutic trial (Classification)

• Creation of an administrative base to capture classification data for correlative studies in ALL treatment protocols and series of historical protocols (Classification)

• Creation of appropriate induction regimens for patients (Induction therapy)

• Correlation between event-free survival and measures of minimal-residual disease/early response

Study Arms (2)

Stratum 3

EXPERIMENTAL

Patients receive oral dexamethasone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; pegaspargase intramuscularly (IM) on day 4, 5, or 6; cytarabine intrathecally (IT) on day 1; and methotrexate IT on day 8 (some patients also receive methotrexate IT on days 15 and 22).

Drug: cytarabine; Drug: dexamethasone; Drug: methotrexate; Drug: pegaspargase; Drug: vincristine sulfate

Stratum 4

EXPERIMENTAL

Patients receive oral prednisone twice daily on days 1-28; vincristine sulfate IV on days 1, 8, 15, and 22; IM SC-PEG E. coli asparaginase on days 2, 5, 8, 12, 15, and 19; daunorubicin hydrochloride IV over 15-20 minutes on days 8, 15, and 22; and methotrexate IT on days 1 and 8 (some patients also receive methotrexate IT on days 15 and 22).

Drug: SC-PEG E. coli L-asparaginase; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: methotrexate; Drug: prednisone

Interventions

SC-PEG E. coli L-asparaginase DRUG

Given IM

Stratum 4

cytarabine DRUG

Given IT

Stratum 3; Stratum 4

daunorubicin hydrochloride DRUG

Given IV

Stratum 4

dexamethasone DRUG

Given orally

Stratum 3

methotrexate DRUG

Given IT

Stratum 3; Stratum 4

pegaspargase DRUG

Given IM

Stratum 3

prednisone DRUG

Given orally

Stratum 4

vincristine sulfate DRUG

Given IV

Stratum 3

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Meets one of the following sets of criteria: * Classification study: * Newly diagnosed ALL\* * Must have one of the following: * ≥ 25% blasts in bone marrow * ≥ 100,000/μl peripheral blood WBC with ≥ 75% blasts, if bone marrow aspiration is omitted for any reason other than medical contraindication * ≥ 30,000/μl WBC with ≥ 75% blasts, if bone marrow aspiration is omitted because of medical contraindication * Immunophenotype and Wright's stain morphology of blast cells consistent with acute lymphocytic leukemia * ≤ 21 years of age at the time of diagnosis * No previous registration on 9900 * Samples must be sent for local institution and COG Reference Laboratory studies NOTE: \*It is urged that a bone marrow aspiration be performed for every patient with suspected ALL. However, a marrow is not required for patients with ≥ 100,000/μl peripheral blood WBC and ≥ 75% blasts or for those patients whose clinical condition precludes performing the procedure safely. Patients with a medical contraindication to the procedure must be discussed with one of the study coordinators and must have a peripheral blood WBC of ≥ 30,000/μl with ≥ 75% blasts. * Induction therapy study: * Patients must have a confirmed diagnosis of B-precursor acute lymphoblastic leukemia * Patients must be 1.001 to 21.999 years at diagnosis NOTE: Patients meeting all of the above eligibility criteria are eligible for registration on 9900 whether or not they are to be entered on a COG frontline protocol for treatment of newly diagnosed ALL. Registration on 9900 is required for all legacy POG institution patients in order to be eligible for entry on the following COG ALL studies, which are either currently open or only temporarily closed: P9407, 9904, 9905, 9907, AALL0031 and AALL00P2. PATIENT CHARACTERISTICS: * See Disease Characteristics PRIOR CONCURRENT THERAPY: * Previously untreated, with the following exception: * Steroid treatment\* in the 48-hour period just prior to study entry will be allowed provided that a physical examination and CBC with differential were performed IMMEDIATELY prior to beginning steroids and results of both are known NOTE: \*Patients on chronic steroid treatment for another disease are NOT eligible for a COG New ALL protocol.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Escherich CS, Chen W, Li Y, Yang W, Nishii R, Li Z, Raetz EA, Devidas M, Wu G, Nichols KE, Inaba H, Pui CH, Jeha S, Camitta BM, Larsen E, Hunger SP, Loh ML, Yang JJ. Germ line genetic NBN variation and predisposition to B-cell acute lymphoblastic leukemia in children. Blood. 2024 May 30;143(22):2270-2283. doi: 10.1182/blood.2023023336.

  PMID: 38446568 DERIVED

MeSH Terms

Conditions

Leukemia

Interventions

calaspargase pegol; Cytarabine; Daunorubicin; Dexamethasone; Methotrexate; pegaspargase; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Dale J. Pullen, MD

  University of Mississippi Cancer Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: December 1, 1999
• Primary Completion: March 1, 2006
• Last Updated: February 23, 2016

Record last verified: 2016-02