Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT00558519 | Completed Phase 2 Results

• 3 other identifiers: CALGB-10403ECOG C10403CDR0000574230
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: 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 phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

B-cell adult acute lymphoblastic leukemia; T-cell adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (5)

• Complete Response Rate

  Complete response rate is defined as the percentage of patients who achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) at the end of induction therapy.

  Up to 8 years post-registration

• Event-free Survival

  EFS was defined as time from registration in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.

  Up to 8 years post-registration

• Disease-free Survival

  DFS was defined as time from bone marrow response in this study to the earliest occurrence of any of the following: failure to achieve bone marrow response (defined using the M bone marrow criteria for acute lymphoblastic leukemia (ALL); if M0 to M1 status (blast cells ,5%) was achieved by the end of induction or extended induction, the patient was considered a responder) by day 60, death, relapse at any site, or development of second malignant disease.

  Up to 8 years post-registration

• Overall Survival

  OS was defined from registration to death resulting from any cause.

  Up to 8 years post-registration

• Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)

  The number of participants who experienced toxicity (defined as at least one grade 3 or higher adverse event at least possibly related to treatment) is reported below.

  Up to 10 years post-registration

Other Outcomes (4)

• Analysis and Description of the Outcomes of Patients Treated on This Study According to Baseline Psychosocial Characteristics, Demographics, and Family Support

  Up to 10 years post-registration

• Outcomes of Patients Treated on This Study According to Pretreatment Characteristics Such as Age, Gender, White Blood Cell Count, Other Hematologic Parameters, Blood Chemistry, Immunophenotype, Cytogenetics and Molecular Genetic Characteristics

  Up to 10 years post-registration

• Adherence of Adult Hematologists/Oncologists and Their Patients to a "Pediatric" Acute Lymphoblastic Leukemia Treatment Regimen and Identification of Reasons for Variances

  Up to 10 years post-registration

Study Arms (1)

Treatment (chemotherapy, radiotherapy)

EXPERIMENTAL

Patients are given a series of leukemia treatments that are divided into several sequential courses and different chemotherapy combinations of treatment. Please see the "Detailed Description" section for more information.

Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Interventions

cyclophosphamide DRUG

Treatment (chemotherapy, radiotherapy)

cytarabine DRUG

Treatment (chemotherapy, radiotherapy)

daunorubicin hydrochloride DRUG

Treatment (chemotherapy, radiotherapy)

dexamethasone DRUG

Treatment (chemotherapy, radiotherapy)

doxorubicin hydrochloride DRUG

Treatment (chemotherapy, radiotherapy)

mercaptopurine DRUG

Treatment (chemotherapy, radiotherapy)

methotrexate DRUG

Treatment (chemotherapy, radiotherapy)

pegaspargase DRUG

Treatment (chemotherapy, radiotherapy)

thioguanine DRUG

Treatment (chemotherapy, radiotherapy)

vincristine sulfate DRUG

Treatment (chemotherapy, radiotherapy)

radiation therapy RADIATION

Treatment (chemotherapy, radiotherapy)

Eligibility Criteria

• Age: 16 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Eligibility Criteria: 1. Diagnosis 1. Newly diagnosed patients with either B-precursor or T-precursor acute lymphoblastic leukemia (WHO criteria). Burkitt type leukemia as defined per protocol is not eligible. Patients known to have Ph+ ALL at time of diagnosis are not eligible. 2. CALGB patients entered on CALGB 10403 who are later found to meet the following criteria for Ph+ ALL should have treatment on this trial discontinued and should be encouraged to enroll on CALGB 10001 or its successor trial: * BCR-ABL fusion transcript determined by FISH or RT-PCR * t(9;22)(q34;q11) or variant determined by cytogenetics Non-CALGB study participants who are later found to be Ph+ should have treatment on this trial discontinued and should be encouraged to enroll on an appropriate clinical trial specifically designed for Ph+ ALL. 2. Age: 16 - 39 years 3. ECOG Performance Status 0-2 4. Patients with Down Syndrome are excluded from this study due to the likelihood of excessive toxicity resulting. These patients should be treated in consultation with a pediatric oncologist. 5. Prior Therapy - No prior therapy except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. 1. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC. 2. Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systemic therapy for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy. 3. Patients receiving prior steroid therapy are eligible for study. The dose and duration of previous steroid therapy should be carefully documented on case report forms.

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related Publications (3)

• Bleyer A: Older adolescents and young adults with acute lymphoblastic leukemia (ALL) in the United States: from the lowest to highest death rate and number of deaths--more rationale for the CALBG-SWOG-ECOG C10403 trial based on COG AALL0232. [Abstract] J Clin Oncol 26 (Suppl 15): A-18034, 2008.

  BACKGROUND

• Advani AS, Larsen E, Laumann K, Luger SM, Liedtke M, Devidas M, Chen Z, Yin J, Foster MC, Claxton D, Coffan K, Tallman MS, Appelbaum FR, Erba H, Stone RM, Hunger SP, McNeer JL, Loh ML, Raetz E, Winick N, Carroll W, Larson RA, Stock W. Comparison of CALGB 10403 (Alliance) and COG AALL0232 toxicity results in young adults with acute lymphoblastic leukemia. Blood Adv. 2021 Jan 26;5(2):504-512. doi: 10.1182/bloodadvances.2020002439.

  PMID: 33496745 DERIVED

• Stock W, Luger SM, Advani AS, Yin J, Harvey RC, Mullighan CG, Willman CL, Fulton N, Laumann KM, Malnassy G, Paietta E, Parker E, Geyer S, Mrozek K, Bloomfield CD, Sanford B, Marcucci G, Liedtke M, Claxton DF, Foster MC, Bogart JA, Grecula JC, Appelbaum FR, Erba H, Litzow MR, Tallman MS, Stone RM, Larson RA. A pediatric regimen for older adolescents and young adults with acute lymphoblastic leukemia: results of CALGB 10403. Blood. 2019 Apr 4;133(14):1548-1559. doi: 10.1182/blood-2018-10-881961. Epub 2019 Jan 18.

  PMID: 30658992 DERIVED

MeSH Terms

Conditions

Leukemia

Interventions

Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Mercaptopurine; Methotrexate; pegaspargase; Thioguanine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; 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; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Results Point of Contact

• Title: Wendy Stock, MD
• Organization: University of Chicago

wstock@medicine.bsd.uchicago.edu

773-834-8982

Study Officials

• Wendy Stock, M.D.

  University of Chicago

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: March 12, 2008
• Primary Completion: September 1, 2016
• Study Completion: June 24, 2024
• Last Updated: April 29, 2026
• Results First Posted: January 31, 2020

Record last verified: 2026-04