Lymphoblastic Leukemia, AcutePhase 3NCT00131027
High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)
A Phase 3 study testing Cyclophosphamide, Daunorubicin and Vincristine in people with Lymphoblastic Leukemia, Acute, run by Japan Adult Leukemia Study Group at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Lymphoblastic Leukemia, Acute
- What is being tested?
- Cyclophosphamide, Daunorubicin and Vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2002to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Previously untreated BCR-ABL-negative ALL
- Age between 25 and 64 years
- Performance status between 0 and 3 (ECOG criteria)
- Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL); kidneys (serum creatinine level < 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
- Written informed consent to participate in the trial
Who cannot join
- Uncontrolled active infection
- Another severe and/or life-threatening disease
- Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
- Another primary malignancy which is clinically active and/or requires medical interventions
- Pregnant and/or lactating women
- Past history of renal failure
Trial locations and contacts
1 site in 1 country.
Fumihiko Hayakawa, MD contact
Japan1 site, 1 recruiting
- Recruiting
Department of Hematology, Nagoya University Graduate School of Medicine
Nagoya, 466-8550
Fumihiko Hayakawa, MD, bun-hy@med.nagoya-u.ac.jp
Fumihiko Hayakawa, MD
About this study
Official title: Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults
The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.
Read the detailed description
Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.
- Conditions
- Lymphoblastic Leukemia, Acute
- Being tested
- Cyclophosphamide, Daunorubicin, Vincristine, Prednisolone, L-asparaginase
- Keywords
- acute lymphoblastic leukemia, newly diagnosed, BCR-ABL-negative
- 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.
CyclophosphamideDrug
DaunorubicinDrug
VincristineDrug
PrednisoloneDrug
L-asparaginaseDrug
CytarabineDrug
EtoposideDrug
DexamethasoneDrug
MethotrexateDrug
3 g/sqm (high dose)
MercaptopurineDrug
DoxorubicinDrug
MethotrexateDrug
0.5 g/sqm (intermediate dose)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | HD-MTX Receives: Drug: Cyclophosphamide; Drug: Daunorubicin; Drug: Vincristine; Drug: Prednisolone; Drug: L-asparaginase; Drug: Cytarabine; Drug: Etoposide; Drug: Dexamethasone; Drug: Methotrexate; Drug: Mercaptopurine; Drug: Doxorubicin |
| B | Active comparator | ID-MTX Receives: Drug: Cyclophosphamide; Drug: Daunorubicin; Drug: Vincristine; Drug: Prednisolone; Drug: L-asparaginase; Drug: Cytarabine; Drug: Etoposide; Drug: Dexamethasone; Drug: Mercaptopurine; Drug: Doxorubicin; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 3 years
Secondary outcomes (2)
Toxicity
Measured: 2 years
The rate of complete remission
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startSep 2002
- Primary completionMar 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, AcuteStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Adult Leukemia Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Fumihiko Hayakawa, MD, Study director, Nagoya UniversityTomoki Naoe, MD, Study chair, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131027
- Sponsor's protocol ID
- JALSG ALL202-O
- Status last verified
- Nov 2008
- First submitted
- 15 Aug 2005
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults
- ClinicalTrials.gov ID
- NCT00131027
- Acronym / sponsor ID
- JALSG ALL202-O
- Conditions
- Lymphoblastic Leukemia, Acute
- Keywords
- acute lymphoblastic leukemia, newly diagnosed, BCR-ABL-negative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Japan Adult Leukemia Study GroupUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
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 investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.
Detailed description
Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Cyclophosphamide, Drug: Daunorubicin, Drug: Vincristine, Drug: Prednisolone, Drug: L-asparaginase, Drug: Cytarabine, Drug: Etoposide, Drug: Dexamethasone, Drug: Methotrexate, Drug: Mercaptopurine, Drug: DoxorubicinHD-MTX |
| B | Active comparator | Drug: Cyclophosphamide, Drug: Daunorubicin, Drug: Vincristine, Drug: Prednisolone, Drug: L-asparaginase, Drug: Cytarabine, Drug: Etoposide, Drug: Dexamethasone, Drug: Mercaptopurine, Drug: Doxorubicin, Drug: MethotrexateID-MTX |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Previously untreated BCR-ABL-negative ALL
- Age between 25 and 64 years
- Performance status between 0 and 3 (ECOG criteria)
- Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL); kidneys (serum creatinine level < 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
- Written informed consent to participate in the trial
Key exclusion criteria (6 listed)
- Uncontrolled active infection
- Another severe and/or life-threatening disease
- Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
- Another primary malignancy which is clinically active and/or requires medical interventions
- Pregnant and/or lactating women
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 |
|---|---|---|
| Cyclophosphamide | Drug | A, B |
| Daunorubicin | Drug | A, B |
| Vincristine | Drug | A, B |
| Prednisolone | Drug | A, B |
| L-asparaginase | Drug | A, B |
| Cytarabine | Drug | A, B |
| Etoposide | Drug | A, B |
| Dexamethasone | Drug | A, B |
| Methotrexate3 g/sqm (high dose) | Drug | A |
| Mercaptopurine | Drug | A, B |
| Doxorubicin | Drug | A, B |
| Methotrexate0.5 g/sqm (intermediate dose) | Drug | B |
Primary outcome
Disease-free survival
Time frame: 3 years
2 secondary outcomes
Toxicity
Time frame: 2 years
The rate of complete remission
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- The JALSG homepageLink provided by the sponsor.
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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.
Fumihiko Hayakawa, MD contact
Fumihiko Hayakawa, MD study director
Nagoya University
Tomoki Naoe, MD study chair
Nagoya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide, Daunorubicin and Vincristine in people with Lymphoblastic Leukemia, Acute, run by Japan Adult Leukemia Study Group at 1 site in Japan.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Nov 2008. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fumihiko Hayakawa, MD (bun-hy@med.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 years). 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 14 Nov 2008.