Acute Lymphoblastic LeukemiaPhase 2NCT00136435
A Study in Adults With Untreated Acute Lymphoblastic Leukemia
A Phase 2 study testing prednisone, doxorubicin and vincristine in people with Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 12 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years. 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?
- prednisone, doxorubicin and vincristine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2002to May 2011
- 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
- Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL.
- No prior therapy for leukemia with the following exceptions:
- up to one week of steroids;
- emergent leukapheresis;
- emergency treatment for hyperleukocytosis with hydroxyurea;
- cranial RT for CNS leukostasis (one dose only);
Show all 9Show fewer
- emergent radiation therapy to the mediastinum.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Between the ages of 18 to 50 years.
Who cannot join
- Uncontrolled active infection.
- Pregnancy or nursing mothers.
- Prior history of pancreatitis.
- Prior history of a cerebrovascular accident or hemorrhage.
- Evidence of infection with the human immunodeficiency virus.
- Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.
- The treating physician should consider all relevant medical and other considerations when deciding whether this protocol is appropriate for a particular patient.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada9 sites
Queen Elizabeth II
Halifax
McMaster University Medical Center
Hamilton, Ontario
Queen's University
Kingston, Ontario
London Health Sciences Centre
London, Ontario
Hospital Maisonneuve-Rosemont
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
Sunnybrook Health Sciences Centre
Toronto, Ontario
Manitoba Blood & Marrow Transplant Program CancerCare Manitoba
Winnipeg, Manitoba
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
University Of Columbia Medical Center
New York, New York
About this study
Official title: A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the Dana Farber Cancer Institute (DFCI) Pediatric Consortium Protocol
The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
Read the detailed description
This study has four treatment phases: 1) induction, 2) central nervous system therapy, 3) intensification, and 4) continuation.
The induction phase lasts one month and eight drugs are used during this phase of treatment. The drugs are administered as follows:
- Prednisone; on days 1-28:
- Vincristine; on days 1, 8, 15, and 22:
- Doxorubicin; on days 1 and 2:
- Methotrexate; on day 3;
- Leucovorin; 36 hours after methotrexate:
- Asparaginase; on day 5:
- Intra-thecal Cytarabine; on days 1, 15, and 29:
- Intra-thecal Methotrexate/Hydrocortisone; on days 15 and 29
A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy. If on day 29, the patients' bone marrow and peripheral blood counts are not in complete remission, then the patient may receive vincristine on days 29, 36 and 43. Bone marrow biopsy will be repeated weekly until complete remission is documented. If the patient does not achieve complete remission by day 49, they will be removed from the study.
Central nervous system (CNS) therapy begins immediately after the end of the induction therapy. This phase of treatment should last 3 weeks. Treatment includes a series of spinal taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed over a two week period. Anti-leukemia drugs will also be given orally. The drugs given are as follows: Vincristine; on day 1: Doxorubicin; on day 1: 6-mercaptopurine (6-MP); on days 1-14: Intra-thecal Methotrexate/Cytarabine; 4 times over 2 weeks.
Radiation therapy (RT) will be delivered in 10 daily treatments during the CNS phase of therapy.
The intensification phase begins as soon as the CNS phase ends and lasts approximately 30 weeks. It consists of cycles of chemotherapy repeated every 3 weeks, along with asparaginase administered weekly. The drugs given are as follows: Vincristine; day 1: Dexamethasone; days 1-5: 6-MP; days 1-14: Doxorubicin; day 1: Asparaginase; weekly: Methotrexate; weekly: Intra-thecal Hydrocortisone/Methotrexate/cytarabine; every 18 weeks.
The continuation phase of treatment begins after the intensification phase. It consists of cycles of chemotherapy repeated every three weeks and will last until the patient is in remission for two years. The drugs given are: Vincristine; day 1 : Prednisone or Dexamethasone; days 1-5: 6-MP; days 1-14: Methotrexate; weekly: Intra-thecal Methotrexate/Cytarabine/Hydrocortisone: every 18 weeks.
During this study, blood tests will be performed at the start of therapy, at day 29 post induction and at the time of each intra-thecal therapy (every 18 weeks).
Bone marrow biopsy/aspirate will be done days 15 and 29 of induction, then every 6 months until completion.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- prednisone, doxorubicin, vincristine, methotrexate, asparaginase
- Keywords
- ALL, acute lymphoblastic leukemia, chemotherapy, asparaginase
- 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.
prednisoneDrug
Induction Phase: Given orally on days 1-28
doxorubicinDrug
Induction Phase: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle
vincristineDrug
Induction: Given intravenously on days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43.
CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle
methotrexateDrug
Induction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks
asparaginaseDrug
Induction: Given into the muscle on day 5
dexamethasoneDrug
Intensification: Given orally on days 1-5 of each cycle
cranial radiationRadiation
Given in 10 daily treatments during CNS therapy phase
leucovorinDrug
Induction: Given intravenously or orally 36 hours after methotrexate
cytarabineDrug
Also called Ara-C
Induction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks
hydrocortisoneDrug
Induction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks.
6-mercaptopurine (6-MP)Drug
CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14.
e. coli L-asparaginaseDrug
Intensification: Given in to the muscle weekly.
| Study group | Role | What they receive |
|---|---|---|
| Only Arm for this study | Other | Only Arm for this study Receives: Drug: prednisone; Drug: doxorubicin; Drug: vincristine; Drug: methotrexate; Drug: asparaginase; Drug: dexamethasone; Radiation: cranial radiation; Drug: leucovorin; Drug: cytarabine; Drug: hydrocortisone; Drug: 6-mercaptopurine (6-MP); Drug: e. coli L-asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asparaginase Completion Rate
Feasibility based on the rate of asparaginase completion defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete all 30 doses of asparaginase as part of intensification therapy. Complete remission is defined as peripheral blood without lymphoblasts, a bone marrow with <5% lymphoblasts, an antigen-presenting cell (APC) > 1000/mm3, 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.
Secondary outcomes (5)
4-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. 4-year DFS is the percent probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 4 years from complete remission. Disease relapse 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 4 years from the date of complete remission.
4-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. 4-year OS is the percent probability of patients remaining alive 4 years from study entry.
Measured: Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years).
4-year Event-Free Survival
Event-Free Survival (EFS) based on the Kaplan-Meier method is defined as the time from study entry to the first event of death during induction therapy, failure to achieve CR at the end of induction, death during remission, or relapse. 4-year EFS is the percent probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 4 years from study entry. Patients not achieving a CR will be considered events at time zero. EFS will be censored at time of last disease assessment. Disease relapse 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, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the 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 (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years).
Post-Induction Nadir Serum Asparaginase Activity Level
Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods.
Measured: Samples for nadir serum asparaginase activity levels were assayed prior to asparaginase dose given during post-induction, at Weeks 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, and 30.
Number of Participants With Asparaginase-Related Toxicity
Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), pancreatitis, thrombotic or bleeding complications, bone fracture, or avascular necrosis based on Common Terminology Criteria for Adverse Events (CTCAE) v2.
Measured: Assessed on an ongoing basis (at least once every 3 months) while patient is on study, and including the treatment phases of Induction, CNS, Intensification, and Continuation. Treatment duration for this study was a median (range) of 507 days (0-1097).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJun 2002
- Primary completionNov 2008
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Principal investigator, Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Daniel J. DeAngelo, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136435
- Sponsor's protocol ID
- 01-175
- Status last verified
- Oct 2025
- First submitted
- 25 Aug 2005
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the Dana Farber Cancer Institute (DFCI) Pediatric Consortium Protocol
- ClinicalTrials.gov ID
- NCT00136435
- Acronym / sponsor ID
- 01-175
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, acute lymphoblastic leukemia, chemotherapy, asparaginase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Queen Elizabeth II Health Sciences Centre
- Study start
- Jun 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.
Detailed description
This study has four treatment phases: 1) induction, 2) central nervous system therapy, 3) intensification, and 4) continuation.
The induction phase lasts one month and eight drugs are used during this phase of treatment. The drugs are administered as follows:
- Prednisone; on days 1-28:
- Vincristine; on days 1, 8, 15, and 22:
- Doxorubicin; on days 1 and 2:
- Methotrexate; on day 3;
- Leucovorin; 36 hours after methotrexate:
- Asparaginase; on day 5:
- Intra-thecal Cytarabine; on days 1, 15, and 29:
- Intra-thecal Methotrexate/Hydrocortisone; on days 15 and 29
A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy. If on day 29, the patients' bone marrow and peripheral blood counts are not in complete remission, then the patient may receive vincristine on days 29, 36 and 43. Bone marrow biopsy will be repeated weekly until complete remission is documented. If the patient does not achieve complete remission by day 49, they will be removed from the study.
Central nervous system (CNS) therapy begins immediately after the end of the induction therapy. This phase of treatment should last 3 weeks. Treatment includes a series of spinal taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed over a two week period. Anti-leukemia drugs will also be given orally. The drugs given are as follows: Vincristine; on day 1: Doxorubicin; on day 1: 6-mercaptopurine (6-MP); on days 1-14: Intra-thecal Methotrexate/Cytarabine; 4 times over 2 weeks.
Radiation therapy (RT) will be delivered in 10 daily treatments during the CNS phase of therapy.
The intensification phase begins as soon as the CNS phase ends and lasts approximately 30 weeks. It consists of cycles of chemotherapy repeated every 3 weeks, along with asparaginase administered weekly. The drugs given are as follows: Vincristine; day 1: Dexamethasone; days 1-5: 6-MP; days 1-14: Doxorubicin; day 1: Asparaginase; weekly: Methotrexate; weekly: Intra-thecal Hydrocortisone/Methotrexate/cytarabine; every 18 weeks.
The continuation phase of treatment begins after the intensification phase. It consists of cycles of chemotherapy repeated every three weeks and will last until the patient is in remission for two years. The drugs given are: Vincristine; day 1 : Prednisone or Dexamethasone; days 1-5: 6-MP; days 1-14: Methotrexate; weekly: Intra-thecal Methotrexate/Cytarabine/Hydrocortisone: every 18 weeks.
During this study, blood tests will be performed at the start of therapy, at day 29 post induction and at the time of each intra-thecal therapy (every 18 weeks).
Bone marrow biopsy/aspirate will be done days 15 and 29 of induction, then every 6 months until completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only Arm for this study | Other | Drug: prednisone, Drug: doxorubicin, Drug: vincristine, Drug: methotrexate, Drug: asparaginase, Drug: dexamethasone, Radiation: cranial radiation, Drug: leucovorin, Drug: cytarabine, Drug: hydrocortisone, Drug: 6-mercaptopurine (6-MP), Drug: e. coli L-asparaginaseOnly Arm for this study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL.
- No prior therapy for leukemia with the following exceptions:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Between the ages of 18 to 50 years.
Key exclusion criteria (7 listed)
- Uncontrolled active infection.
- Pregnancy or nursing mothers.
- Prior history of pancreatitis.
- Prior history of a cerebrovascular accident or hemorrhage.
- Evidence of infection with the human immunodeficiency virus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisoneInduction Phase: Given orally on days 1-28 | Drug | Only Arm for this study |
| doxorubicinInduction Phase: Given intravenously on day 1 and day 2 CNS Therapy: Given intravenously on day 1 Intensification: Given day 1 of each cycle | Drug | Only Arm for this study |
| vincristineInduction: Given intravenously on days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43. CNS Therapy: Given intravenously on day 1. Intensification: Given intravenously on day 1 of each cycle. Continuation: Given intravenously on day 1 of each cycle | Drug | Only Arm for this study |
| methotrexateInduction: Given intravenously on day 3. CNS Therapy: Given intrathecally 4 times over two weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intravenously weekly and intrathecally every 18 weeks | Drug | Only Arm for this study |
| asparaginaseInduction: Given into the muscle on day 5 | Drug | Only Arm for this study |
| dexamethasoneIntensification: Given orally on days 1-5 of each cycle | Drug | Only Arm for this study |
| cranial radiationGiven in 10 daily treatments during CNS therapy phase | Radiation | Only Arm for this study |
| leucovorinInduction: Given intravenously or orally 36 hours after methotrexate | Drug | Only Arm for this study |
| cytarabineAlso: Ara-CInduction: Given intrathecally days 1, 15, 29 CNS Therapy: Given intrathecally 4 times over 2 weeks Intensification: Given intrathecally every 18 weeks Continuation: Given intrathecally every 18 weeks | Drug | Only Arm for this study |
| hydrocortisoneInduction: Given intrathecally on days 15 and 29. Intensification: Given intrathecally every 18 weeks. Continuation: Given intrathecally every 18 weeks. | Drug | Only Arm for this study |
| 6-mercaptopurine (6-MP)CNS Therapy: Taken orally on days 1-14. Intensification: Taken orally on days 1-14. Continuation: Taken orally on days 1-14. | Drug | Only Arm for this study |
| e. coli L-asparaginaseIntensification: Given in to the muscle weekly. | Drug | Only Arm for this study |
Primary outcome
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 completion defined as the percentage of patients who, after having achieved a complete remission after induction therapy, complete all 30 doses of asparaginase as part of intensification therapy. Complete remission is defined as peripheral blood without lymphoblasts, a bone marrow with <5% lymphoblasts, an antigen-presenting cell (APC) > 1000/mm3, platelets > 100,000/mm3, and no evidence of extramedullary leukemia.
5 secondary outcomes
4-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 4 years from the date of complete remission.
4-year Overall Survival
Time frame: Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years).
4-year Event-Free Survival
Time frame: Assessed continuously throughout the treatment period, and annually for 5 years following the completion of protocol treatment (unless the participant dies or is lost to follow-up). Median follow-up for the whole trial is 4.5 years (95% CI:4.1-5.0 years).
Post-Induction Nadir Serum Asparaginase Activity Level
Time frame: Samples for nadir serum asparaginase activity levels were assayed prior to asparaginase dose given during post-induction, at Weeks 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, and 30.
Number of Participants With Asparaginase-Related Toxicity
Time frame: Assessed on an ongoing basis (at least once every 3 months) while patient is on study, and including the treatment phases of Induction, CNS, Intensification, and Continuation. Treatment duration for this study was a median (range) of 507 days (0-1097).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J. DeAngelo, MD, PhD principal investigator
Dana-Farber Cancer Institute
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing prednisone, doxorubicin and vincristine in people with Acute Lymphoblastic Leukemia, run by Dana-Farber Cancer Institute at 12 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 9 inclusion and 7 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 20 Oct 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2025.