LeukemiaPhase 2NCT01005914
Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase 2 study testing cyclophosphamide, cytarabine and dexamethasone in people with Leukemia, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- cyclophosphamide, cytarabine and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be newly diagnosed (untreated) with Acute Lymphoblastic Leukemia based on a bone marrow examination unless there is a contraindication to having the test performed. This includes precursor-B ALL, precursor-T ALL, and Philadelphia chromosome positive ALL. For reference, see criteria by Center for International Blood and Marrow Transplant Research (CIBMTR).> 20% blasts on a bone marrow aspirate OR If a bone marrow aspirate is not obtained, the diagnosis of acute leukemia can be established by a pathologic diagnosis of acute leukemia on a bone marrow biopsy OR A complete blood count documenting the presence of at least 10,000 white blood cells (WBC)/μl and at least 20% circulating blasts
- Adults, 18 to 60 years of age.
- Women of child bearing potential (WOCBP) must be willing to use adequate contraception to avoid pregnancy for the duration of study participation.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Adequate renal function defined as: Serum creatinine ≤ 2.0 x upper limit normal (ULN) for institution
- Adequate hepatic function defined as:Total bilirubin ≤ 2.0 x ULN for institution Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN for institution
- Patient must have the ability to understand and the willingness to sign a written informed consent document. The patient and/or the patient's legally authorized guardian must acknowledge consent for treatment as a human subject on this study.
Who cannot join
- Mature B (Burkitt's) ALL will be excluded.
- An active malignancy other than ALL (with the exception of basal and/or squamous cell skin cancers and curatively treated carcinoma of the cervix) within 5 past years of study entry.
- Documented central nervous system (CNS) involvement with leukemia will be excluded. A diagnostic lumbar puncture will not be part of screening procedures.
- Severe pulmonary, renal, or hepatic disease not related to the patient's ALL will be excluded.
- Cardiac dysfunction as defined by:Myocardial infarction within the last 6 months of study entry, or Reduced left ventricular function with an ejection fraction ≤50% as measured by Multigated Acquisition (MUGA) scan or echocardiogram at study entry, Unstable angina, Unstable cardiac arrhythmias, New York Heart Association (NYHA) Class III or IV heart failure, Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Known or suspected human immunodeficiency virus (HIV)-positive patients are excluded from the study because of possible risk of lethal infection when treated with marrow suppressive therapy.
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- Any concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.) or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Patients who have had chemotherapy or radiotherapy for ALL prior to entering the study will be excluded. Hydroxyurea and one dose of intravenous vincristine are allowed prior to registration for patient convenience. Prior steroid therapy is allowable, ≤5 days prior to the start of the regimen.
- Patients may not have received any other investigational agents within the last 30 days.
- WOCBP who are unwilling or unable to use an acceptable method of contraception for the entire study period. Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant. Women with a positive serum pregnancy test on enrollment or prior to study drug administration will be excluded.
- Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy of his partner for the entire study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Phase II Trial of the Addition of PEG-Asparaginase to the Hyper-CVAD Regimen in Adult Newly-Diagnosed Acute Lymphoblastic Leukemia
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 the side effects of giving pegaspargase together with combination chemotherapy and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- To estimate the complete response rate in patients with newly diagnosed acute lymphoblastic leukemia treated with pegaspargase in combination with hyper-CVAD regimen comprising cyclophosphamide, dexamethasone, vincristine sulfate, doxorubicin hydrochloride, methotrexate, and cytarabine.
- To determine the safety and tolerability of this regimen in these patients.
Secondary
- To evaluate the progression-free survival and overall survival of patients treated with this regimen.
- To determine the half-life of pegaspargase when administered in combination with hyper-CVAD regimen.
- To monitor the development of neutralizing antibodies to pegaspargase when administered in combination with hyper-CVAD regimen.
- To assess minimal residual disease by flow cytometry at the end of courses 1A and 1B.
OUTLINE: This is a multicenter study.
- Hyper-CVAD regimen (courses 1, 3, 5, and 7): Patients receive cyclophosphamide IV over 2-3 hours twice daily on days 1-3, dexamethasone IV on days 1-4 and 11-14, methotrexate intrathecally (IT) on day 2, doxorubicin hydrochloride IV over 2 hours and pegaspargase IV over 1-2 hours on day 4, vincristine sulfate IV on days 4 and 11, and cytarabine IT on day 8.
- High-dose methotrexate/cytarabine regimen (courses 2, 4, 6, and 8): Patients receive methotrexate IV continuously over 24 hours on day 1, methylprednisolone IV twice daily on days 1-3, methotrexate IT on day 2, cytarabine IV over 2 hours twice daily on days 2 and 3, pegaspargase IV over 1-2 hours on day 3, and cytarabine IT on day 8.
Treatment repeats every 3-4 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with Philadelphia chromosome-positive disease also receive oral imatinib mesylate daily beginning at diagnosis.
Patients who complete 8 courses of chemotherapy and are not candidates for hematopoietic stem cell transplantation receive maintenance therapy off study.
Blood samples are collected at baseline and periodically during study for pharmacokinetics and neutralizing antibody assays.
After completion of study therapy, patients are followed up every 6 months.
- Conditions
- Leukemia
- Being tested
- cyclophosphamide, cytarabine, dexamethasone, doxorubicin hydrochloride, imatinib mesylate
- Keywords
- adults, Philadelphia chromosome precursor ALL,, T-cell ALL, untreated ALL
- Medical subject headings
- Leukemia, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Also called Cytoxan, Neosar, CTX
Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3
cytarabineDrug
Also called Cytosar-U, Ara-C, Arabinosylcytosine
Day 2 \& 3: 3g/m2 IV over 2 hours q12 X 4
dexamethasoneDrug
Also called Decadron, DexPak, dex
Day 1-4; 11-14: 40 mg daily
Also called Adriamycin RDF, Adriamycin PFS
Day 4: 50 mg/m2 IV over 2 hours
imatinib mesylateDrug
Also called Gleevec, Glivec
600 mg/day
methotrexateDrug
Also called Trexall, Rheumatrex, MTX
Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion
Also called Medrol, Depo-Medrol, Solu-Medrol
Day 1-3: 50mg IV BID
pegaspargaseDrug
Also called Onscapar, PEG-L-asparaginase
Day 3/Day4: 2,500 IU/ m2 IV
Also called Marqibo
Day 4 \& 11: 2 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3
Drug:cytarabine Day 2 \& 3: 3g/m2 IV over 2 hours q12 X 4
Drug:dexamethasone Day 1-4; 11-14: 40 mg daily
Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours
Drug:imatinib mesylate 600 mg/day
Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion
Drug: methylprednisolone Day 1-3: 50mg IV BID
Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV
Drug: vincristine sulfate Day 4 \& 11: 2 mg IV Receives: Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: imatinib mesylate; Drug: methotrexate; Drug: methylprednisolone; Drug: pegaspargase; Drug: vincristine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen
The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.
Measured: After day 4 of treatment
Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.
Measured: The assessment of safety will be based mainly on the frequency of adverse events
Secondary outcomes (5)
2-year Progression-free Survival
Measured: After completion of 8 cycles
Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2
Measured: An interim analysis of safety is planned after the enrollment of 15 evaluable patients.
Overall Survival
Measured: At least every 6 months until death.
Rate of Minimal Residual Disease
Cycle 1A: Days 1 through 14 Cycle 1B: Days 1 through 8, after the first 14 days of cycle 1A
Measured: End of cycles 1A and 1B
Half-life of Pegaspargase
Measured: The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2013
- Study completionMay 2014
Why it stopped: Increased rate of bacterial infections
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 LeukemiaStudies of the same condition, open and under way.
- More trials run by OHSU Knight 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Hayes-Lattin, OHSU Knight Cancer Institute
- Investigators
- Brandon Hayes-Lattin, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005914
- Sponsor's protocol ID
- IRB00004913
- Other IDs
- OHSU-4913, ENZON-OHSU-4913, CDR0000642363
- Status last verified
- Dec 2022
- First submitted
- 30 Oct 2009
- Last updated
- 6 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of the Addition of PEG-Asparaginase to the Hyper-CVAD Regimen in Adult Newly-Diagnosed Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01005914
- Acronym / sponsor ID
- IRB00004913
- Conditions
- Leukemia
- Keywords
- adults, Philadelphia chromosome precursor ALL,, T-cell ALL, untreated ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased rate of bacterial infections
- Enrolment
- 11 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the side effects of giving pegaspargase together with combination chemotherapy and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
Primary
- To estimate the complete response rate in patients with newly diagnosed acute lymphoblastic leukemia treated with pegaspargase in combination with hyper-CVAD regimen comprising cyclophosphamide, dexamethasone, vincristine sulfate, doxorubicin hydrochloride, methotrexate, and cytarabine.
- To determine the safety and tolerability of this regimen in these patients.
Secondary
- To evaluate the progression-free survival and overall survival of patients treated with this regimen.
- To determine the half-life of pegaspargase when administered in combination with hyper-CVAD regimen.
- To monitor the development of neutralizing antibodies to pegaspargase when administered in combination with hyper-CVAD regimen.
- To assess minimal residual disease by flow cytometry at the end of courses 1A and 1B.
OUTLINE: This is a multicenter study.
- Hyper-CVAD regimen (courses 1, 3, 5, and 7): Patients receive cyclophosphamide IV over 2-3 hours twice daily on days 1-3, dexamethasone IV on days 1-4 and 11-14, methotrexate intrathecally (IT) on day 2, doxorubicin hydrochloride IV over 2 hours and pegaspargase IV over 1-2 hours on day 4, vincristine sulfate IV on days 4 and 11, and cytarabine IT on day 8.
- High-dose methotrexate/cytarabine regimen (courses 2, 4, 6, and 8): Patients receive methotrexate IV continuously over 24 hours on day 1, methylprednisolone IV twice daily on days 1-3, methotrexate IT on day 2, cytarabine IV over 2 hours twice daily on days 2 and 3, pegaspargase IV over 1-2 hours on day 3, and cytarabine IT on day 8.
Treatment repeats every 3-4 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with Philadelphia chromosome-positive disease also receive oral imatinib mesylate daily beginning at diagnosis.
Patients who complete 8 courses of chemotherapy and are not candidates for hematopoietic stem cell transplantation receive maintenance therapy off study.
Blood samples are collected at baseline and periodically during study for pharmacokinetics and neutralizing antibody assays.
After completion of study therapy, patients are followed up every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: cyclophosphamide, Drug: cytarabine, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: imatinib mesylate, Drug: methotrexate, Drug: methylprednisolone, Drug: pegaspargase, Drug: vincristine sulfateDrug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 \& 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 \& 11: 2 mg IV |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients must be newly diagnosed (untreated) with Acute Lymphoblastic Leukemia based on a bone marrow examination unless there is a contraindication to having the test performed. This includes precursor-B ALL, precursor-T ALL, and Philadelphia chromosome positive ALL. For reference, see criteria by Center for International Blood and Marrow Transplant Research (CIBMTR).> 20% blasts on a bone marrow aspirate OR If a bone marrow aspirate is not obtained, the diagnosis of acute leukemia can be established by a pathologic diagnosis of acute leukemia on a bone marrow biopsy OR A complete blood count documenting the presence of at least 10,000 white blood cells (WBC)/μl and at least 20% circulating blasts
- Adults, 18 to 60 years of age.
- Women of child bearing potential (WOCBP) must be willing to use adequate contraception to avoid pregnancy for the duration of study participation.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Adequate renal function defined as: Serum creatinine ≤ 2.0 x upper limit normal (ULN) for institution
Key exclusion criteria (11 listed)
- Mature B (Burkitt's) ALL will be excluded.
- An active malignancy other than ALL (with the exception of basal and/or squamous cell skin cancers and curatively treated carcinoma of the cervix) within 5 past years of study entry.
- Documented central nervous system (CNS) involvement with leukemia will be excluded. A diagnostic lumbar puncture will not be part of screening procedures.
- Severe pulmonary, renal, or hepatic disease not related to the patient's ALL will be excluded.
- Cardiac dysfunction as defined by:Myocardial infarction within the last 6 months of study entry, or Reduced left ventricular function with an ejection fraction ≤50% as measured by Multigated Acquisition (MUGA) scan or echocardiogram at study entry, Unstable angina, Unstable cardiac arrhythmias, New York Heart Association (NYHA) Class III or IV heart failure, Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
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 |
|---|---|---|
| cyclophosphamideAlso: Cytoxan, Neosar, CTXDay 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 | Drug | Group 1 |
| cytarabineAlso: Cytosar-U, Ara-C, ArabinosylcytosineDay 2 \& 3: 3g/m2 IV over 2 hours q12 X 4 | Drug | Group 1 |
| dexamethasoneAlso: Decadron, DexPak, dexDay 1-4; 11-14: 40 mg daily | Drug | Group 1 |
| doxorubicin hydrochlorideAlso: Adriamycin RDF, Adriamycin PFSDay 4: 50 mg/m2 IV over 2 hours | Drug | Group 1 |
| imatinib mesylateAlso: Gleevec, Glivec600 mg/day | Drug | Group 1 |
| methotrexateAlso: Trexall, Rheumatrex, MTXDay 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion | Drug | Group 1 |
| methylprednisoloneAlso: Medrol, Depo-Medrol, Solu-MedrolDay 1-3: 50mg IV BID | Drug | Group 1 |
| pegaspargaseAlso: Onscapar, PEG-L-asparaginaseDay 3/Day4: 2,500 IU/ m2 IV | Drug | Group 1 |
| vincristine sulfateAlso: MarqiboDay 4 \& 11: 2 mg IV | Drug | Group 1 |
Primary outcome
Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen
Time frame: After day 4 of treatment
The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.
Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.
Time frame: The assessment of safety will be based mainly on the frequency of adverse events
5 secondary outcomes
2-year Progression-free Survival
Time frame: After completion of 8 cycles
Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2
Time frame: An interim analysis of safety is planned after the enrollment of 15 evaluable patients.
Overall Survival
Time frame: At least every 6 months until death.
Rate of Minimal Residual Disease
Time frame: End of cycles 1A and 1B
Half-life of Pegaspargase
Time frame: The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- 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.
Brandon Hayes-Lattin principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide, cytarabine and dexamethasone in people with Leukemia, run by OHSU Knight Cancer Institute at 1 site in United States.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 11 Feb 2015). 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?
Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen (time frame: After day 4 of treatment). 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?
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 6 Jan 2023.