TOTXVI: Total Therapy Study XVI For Newly Diagnosed Patients With Acute Lymphoblastic Leukemia


Leukemia / Lymphoma

Diseases Treated:

Acute Lymphoblastic Leukemia

Eligibility Overview:

  • 18 years of age or younger
  • Newly diagnosed acute lymphoblastic leukemia (ALL)
  1. Primary Objective

    The primary objective of this study (TOTXVI) is to compare the clinical benefit, the pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG) asparaginase given in higher dose (HD PEG) versus those of PEG-asparaginase given in conventional dose (CD PEG) during the continuation phase.

    Trial Outline

    Treatment will consist of 3 main phases:

    • Remission Induction - remission induction chemotherapy (6-7 weeks) 
    • Consolidation (8 weeks)
    • Continuation (120 weeks)


    Drugs: Prednisone, vincristine, daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, doxorubicin, cyclophosphamide, cytarabine, thioguanine, clofarabine, methotrexate, mercaptopurine, dexamethasone, etoposide, dasatinib

    Study Arms

    Experimental: HD PEG

    Participants randomized to receive higher dose PEG-asparaginase during the continuation phase.

    Active Comparator: CD PEG

    Participants randomized to receive conventional dose PEG-asparaginase during the continuation phase.

    Eligibility Criteria

    Inclusion Criteria:

    • Participant has a confirmed diagnosis of precursor B-cell or precursor T-cell acute lymphocytic leukemia (ALL) by immunophenotyping
    • Participant is less than or equal to 18 years of age
    • Limited prior therapy, including systemic glucocorticoids for 1 week or less, 1 dose of vincristine, emergency radiation therapy to the mediastinum and 1 dose of intrathecal chemotherapy. Other circumstances must be cleared by principal investigator (PI) or co-PI.
    • Written, informed consent and assent following Institutional Review Board, NCI, FDA, and Office for Human Research Protections (OHRP) Guidelines

    Exclusion Criteria:

    • Participants with prior therapy, other than that listed above
    • Pregnant or lactating
    • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

    Study Design

    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Open Label
    • Primary Purpose: Treatment
  2. About this clinical trial

    Acute lymphoblastic leukemia (ALL) is a cancer that affects the white blood cells (the cells that fight infection and help protect the body against disease). Successful treatment for ALL, resulting in long-term remission (no signs or symptoms of leukemia) occurs when patients are treated with several very strong chemotherapy drugs. In this trial, researchers want to find better treatments for ALL while trying to reduce some of the long-term side effects common with strong chemotherapy drugs.

    Purpose of this clinical trial

    The main goal of this clinical trial is to try and improve the cure rate of children with ALL. To do this, St. Jude researchers will:

    • Compare the effects of a higher dose versus a standard dose of a drug called PEG-asparaginase to find out if the higher dose will result in better response rates without causing significantly more side effects
    • Find out if giving different treatments based on a participant’s risk of leukemia coming back after treatment will result in better response rates in this study when compared to past studies


    Your child’s specific ALL diagnosis will determine the treatment plan that will be used. Your child will be placed into one of three groups, depending on whether your child’s cancer is at high, standard or low risk of coming back after treatment.

    Eligibility overview

    • 18 years of age or younger
    • Newly diagnosed acute lymphoblastic leukemia (ALL)
  3. TOTXVI  Quick View 
    Sponsor St. Jude Children's Research Hospital
    Collaborators National Cancer Institute (NCI) and Enzon Pharmaceuticals, Inc. identifier NCT00549848
    Trial start date October 2007
    Estimated enrollment 420
    Study type Interventional
    Study phase Phase 3
    Condition Acute lymphoblastic leukemia (ALL)
    Ages Up to 18 years
    Principal investigator Sima Jeha, MD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss TOTXVI St. Jude Physician/Patient Referral Office


Sima Jeha, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.