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Acute Lymphoblastic LeukemiaPhase 2NCT00476190

ALL Adult Consortium Trial: Adult ALL Trial

A Phase 2 study testing Doxorubicin, Cytarabine and Methotrexate in people with Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Doxorubicin, Cytarabine and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
15 sitesin 2 countries
Study dates
Apr 2007to Mar 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Canada8 sites

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • QEII, Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • The Moncton Hospital

    Moncton, New Brunswick

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Hopital Notre-Dame

    Montreal, Quebec

  • McGill University Department of Oncology

    Montreal, Quebec

  • Vancouver Cancer Center

    Vancouver, British Columbia, V5Z 4E6

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States7 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Children's Hospital of Boston

    Boston, Massachusetts, 02115

  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • LDS Hospital

    Salt Lake City, Utah, 84143

Other trials in United States

About this study

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>

Read the detailed description
  • 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.
Keywords
ALL
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxorubicinDrug

    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.

  • CytarabineDrug

    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

  • MethotrexateDrug

    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.

  • VincristineDrug

    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.

  • CyclophosphamideDrug

    Consolidation IB: Intravenously on day 1

  • MethylprednisoneDrug

    Prophase: Intravenously on days 1-3

  • Hydrocortisone Sodium SuccinateDrug

    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.

  • DexamethasoneDrug

    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-MPDrug

    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-AsparaginaseDrug

    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.

  • ImatinibDrug

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

  • EtoposideDrug

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

  • Radiation TherapyProcedure or surgery

    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 AsparaginaseDrug

    Intramuscularly Day 7 of Induction.

Study groups in NCT00476190
Study groupRoleWhat they receive
Pre-amendment cohort, 2500 IU/m2 q2 weeksExperimentalThe first 66 patients enrolled under the initial design. In the post-induction phases, IV asparaginase was administered every two weeks at the higher dose of 2500 IU/m2, for a total of 30 post-induction weeks. IV asparaginase was administered as a single dose during induction. Protocol therapy was comprised of 6 phases: Prophase, Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Receives: Drug: Doxorubicin; Drug: Cytarabine; Drug: Methotrexate; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Methylprednisone; Drug: Hydrocortisone Sodium Succinate; Drug: Dexamethasone; Drug: 6-MP; Drug: PEG-Asparaginase; Drug: Imatinib; Drug: Etoposide; Procedure: Radiation Therapy; Drug: E. coli Asparaginase
Post-amendment cohort, 2000 IU/m2 q3 weeksExperimentalThe 46 patients enrolled under amended design, after August 1, 2011. In the post-induction phases, IV asparaginase was administered every 3 weeks at the dose of 2000 IU/m2, for a total of 30 post-induction weeks. E. coli asparaginase was administered as a single dose during induction. Protocol therapy was comprised of 6 phases: Prophase, Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Receives: Drug: Doxorubicin; Drug: Cytarabine; Drug: Methotrexate; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Methylprednisone; Drug: Hydrocortisone Sodium Succinate; Drug: Dexamethasone; Drug: 6-MP; Drug: PEG-Asparaginase; Drug: Imatinib; Drug: Etoposide; Procedure: Radiation Therapy; Drug: E. coli Asparaginase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asparaginase Completion Rate

    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.

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

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

    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.

    Measured: 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).

Secondary outcomes (3)

  1. Complete Remission Rate

    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.

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

  2. 3-year Disease Free Survival

    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.

    Measured: 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.

  3. 3-year Overall Survival

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionSep 2013
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00476190
Sponsor's protocol ID
06-254
Status last verified
Jun 2025
First submitted
18 May 2007
Last updated
12 Jun 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin, Cytarabine and Methotrexate in people with Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00476190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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