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Completed

NCT Number: NCT00476190

ALL Adult Consortium Trial: Adult ALL Trial

The purpose of this study is to determine the safety and effectiveness of a multi-drug chemotherapy regimen in adult patients with Acute Lymphoblastic Leukemia (ALL). We will use a regimen that is often used in pediatric patients and we will add drugs called PEG-asparaginase and E. coli asparaginase. PEG-asparaginase has been given as an injection in the past and has been used in treatment with both children and adults with ALL. Information from those other research studies suggests that intravenous PEG-asparaginase has been administered safely in both children and adults. We hope to gain more information about the participants disease and how it responds to standard chemotherapy drugs used to treat ALL>

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver Cancer Center, Vancouver, British Columbia, Canada

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About this study

  • This study has several periods of treatment called phases and uses several different drugs in each phase. The drugs may be given by mouth, into a vein, or into the spinal fluid (called intrathecal chemotherapy). In some individuals this treatment helps prevent leukemia cells from coming back in the spinal fluid and brain. Radiation therapy will also be administered as part of this treatment regimen.
  • The treatment program consists of 2-different treatment arms with six separate phases of therapy. The phases of treatment are: (1) Steroid prophase (2) Induction (3) Consolidation I (4) Central nervous system (CNS) therapy (5) Consolidation II (6) Continuation.
  • The participants treatment arm will depend on the status of their leukemia at the end of the induction therapy (the second phase of treatment). Arm A: all participants who achieve complete remission after Induction and Arm B: all participants who fail to achieve a complete remission after Induction.
  • Steroid Prophase: All participants are involved in this treatment phase which consists of two drugs, one given intravenously (IV) and one given intrathecally. This phase lasts 3 days and the purpose is to collect scientific data that might be useful in the future and to see how steroids work in treating leukemia
  • Induction: This phase begins immediately after the steroid prophase and lasts about 1 month. Induction is used to cause a remission. Eight drugs are used during this phase of treatment, and administration is either orally, IV or intrathecal. On day 29, participant's bone marrow and peripheral blood counts will be tested. If they have achieved complete remission or partial remission, they will proceed to the next phase of treatment. If they are not in complete remission, they will receive vincristine by IV on days 32, 39 and 46, until complete remission is achieved. If they do not achieve complete or partial remission by day 53 they will be removed from the study.
  • Consolidation I: This phase of treatment begins as soon as there is a documented confirmation that the participant's leukemia is either in complete or partial remission. Treatment in this phase lasts about 7 weeks and is intended to further reduce the number of leukemia cells in the body. This consolidation treatment consists of 3 phases: 1A, 1B and 1C. Each phase involves a three week cycle of chemotherapy. Arm A and Arm B will be assigned according to remission status after induction therapy and will determine the order that the participant follows the Consolidation phases.
  • Central Nervous System (CNS) Therapy: CNS therapy begins 3 weeks after the end of Consolidation I therapy and should last 3 weeks. Treatment includes a series of lumbar punctures with the administration of anti-leukemia drug as well as oral drugs and IV drugs. Radiation therapy will also be given during this phase of therapy. The purpose of radiation therapy is to prevent leukemia from coming back in the brain. Radiation therapy will be given in either 8 or 10 daily treatments.
  • Consolidation II Therapy: This phase begins as soon as CNS therapy ends and lasts about 27-30 weeks. It consists of cycles of chemotherapy repeated every three weeks along with IV PEG-asparaginase administered every 3 weeks. The cycles will be repeated until the participant receives a total of 10 doses of asparaginase.
  • Continuation Therapy: This phase begins after the end of the Consolidation II phase. The goal of this phase is to get rid of all leukemia in the body. It consists of cycles of chemotherapy repeated every three weeks and will last until the participant has been in remission for two years.
  • During all phases of treatment, participants will have tests and procedures to monitor their health and for research purposes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
  • Age 18.00-50.99 years

Exclusion criteria

  • Prior anti-leukemic therapy except 1 week or less of steroids, and/or emergent radiation therapy to the mediastinum, or hydroxyurea or emergent leukopheresis
  • Known HIV positive
  • Secondary ALL
  • Pregnant or breast feeding women
  • Patients with an active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely

Treatment and study plan

Doxorubicin

Drug

Induction: Intravenously on days 4 and 5. Consolidation 1A: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously day 1 of each cycle.

Cytarabine

Drug

Prophase: Intravenously on days 1-3. Induction: Intrathecal on days 15 or 18. Consolidation IB: Intravenously or subcutaneous on days 2-5 and 9-12. Consolidation IC: Intravenously every 12 hours starting on day 1 CNS Therapy: Intrathecal 4 times over 2 weeks. Consolidation II: Intrathecal once every 18 weeks Continuation: Intrathecal every 18 weeks

methotrexate

Drug

Induction: Intravenously on day 6 and intrathecally on day 29 or 32. Consolidation IA: Intravenously on day 1 and intrathecally on Day 1 (prior to IV).

Consolidation IB: Intrathecally on day 1. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation: Intrathecally once every 18 weeks. Continuation: Intravenously weekly and intrathecally every 18 weeks.

Vincristine

Drug

Induction: Intravenously on days 4, 11, 18, 25. Consolidation IA: Intravenously on day 1. CNS Therapy: Intravenously on day 1. Consolidation II: Intravenously on day 1 of each cycle.

Cyclophosphamide

Drug

Consolidation IB: Intravenously on day 1

Methylprednisone

Drug

Prophase: Intravenously on days 1-3

Hydrocortisone Sodium Succinate

Drug

Induction: Intrathecally on day 15 or 18. CNS Therapy: Intrathecally 4 times over 2 weeks. Consolidation II: Intrathecally once every 18 weeks. Continuation: Intrathecally every 18 weeks.

Dexamethasone

Drug

Consolidation IC: Orally on days 1-5 twice per day. Consolidation II: Orally on days 1-5 of each cycle. Continuation: Orally on days 1-5 of each cycle.

6-MP

Drug

Induction: Orally on days 3-43 or 33-46. Consolidation IA: orally on days 1-14. Consolidation IB: orally on days 1-14. CNS Therapy: Orally on days 1-14. Consolidation II: Orally on days 1-14. Continuation: Orally on days 1-14 of each cycle.

PEG-Asparaginase

Drug

Consolidation IC: Intravenously every 3 weeks, starting on day 8. CNS Therapy: Intravenously every 3 weeks, starting 3 weeks after the Consolidation IC dose.

Consolidation II: Intravenously every 3 weeks.

Imatinib

Drug

Used for PH+ ALL subjects enrolled prior to May 1st 2011 only and is used continuously throughout every phase of treatment.

etoposide

Drug

Consolidation IC: intravenously on days 3, 4 and 5 of this cycle.

Radiation Therapy

Procedure

Given during CNS Therapy either 8 or 10 daily treatments, on days 1-8 or 1-10, depending upon leukemia involvement in the CSF

E. coli Asparaginase

Drug

Intramuscularly Day 7 of Induction.

Primary outcomes

  1. Asparaginase Completion Rate

    Time frame: Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first.

    Feasibility based on the rate of asparaginase completed defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete >25 weeks of IV PEG asparaginase as part of intensification therapy. Complete remission is defined as an interpretable bone marrow (a specimen with normal marrow elements present) with fewer than 5% lymphoblasts and peripheral blood without lymphoblasts, and an antigen presenting cell (APC) > 1000/mm3 and platelets > 100,000/mm3, and no evidence of extramedullary leukemia.

  2. Number of Participants With Grade 3 or Worse Toxicity.

    Time frame: Assessed on an ongoing basis (at least once every 3 months) while on study, including the treatment phases of Induction, Consolidation I & II, CNS, and Continuation. Treatment duration for this study was a median (range) of 287 days (2-974).

    Defined as the number of participants who experience the following grade 3 or worse adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) v3: Neutrophils, Platelets, Febrile neutropenia, Infection, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Bilirubin, Liver dysfunction/failure, Hyperglycemia, Stomatitis, CNS hemorrhage, Thrombosis, Seizure, Osteonecrosis, Hypersensitivity, Pancreatitis, Neuropathy.

Secondary outcomes

  1. Complete Remission Rate

    Time frame: 3-day Steroid prophase and 4-week induction treatment period. Participants are assessed on Day 32 of induction.

    Complete remission rate is defined as the percentage of patients with an interpretable bone marrow (a specimen with normal marrow elements present) with fewer than 5% lymphoblasts and peripheral blood without lymphoblasts, and an antigen presenting cell (APC) > 1000/mm3 and platelets > 100,000/mm3, and no evidence of extramedullary leukemia.

  2. 3-year Disease Free Survival

    Time frame: Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (up to 5 years). Relevant for this measure is 3 years from the date of complete remission.

    Disease-Free Survival (DFS) based on the Kaplan-Meier method is defined as the time from achieving a complete remission to the first of disease recurrence or death, censored at time of last disease assessment. 3-year DFS is the percentage probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 3 years from complete remission. Disease release is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, fluorescent in situ hybridization (FISH), immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the cerebrospinal fluid (CSF) may qualify as CNS leukemia) also qualifies if confirmed by the PI.

  3. 3-year Overall Survival

    Time frame: Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (up to 5 years). Relevant for this measure is 3 years from the date of study entry.

    Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death from any cause and will be censored the date last known alive.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Boston Children's Hospital
  • Massachusetts General Hospital
  • NCIC Clinical Trials Group

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2020
First posted
May 21, 2007
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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