Lymphoblastic Leukemia, AcutePhase 2NCT00131053
Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study testing Methotrexate, Prednisolone and Dexamethasone 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 efficacy and safety for treating adult ALL patients with the pediatric protocol. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Lymphoblastic Leukemia, Acute
- What is being tested?
- Methotrexate, Prednisolone and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2002to Sep 2011
- Phase
- Phase 2
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously untreated BCR-ABL-negative ALL
- Age between 15 and 24 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: Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.
Read the detailed description
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.
- Conditions
- Lymphoblastic Leukemia, Acute
- Being tested
- Methotrexate, Prednisolone, Dexamethasone, Vincristine, Pirarubicin
- 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.
MethotrexateDrug
PrednisoloneDrug
DexamethasoneDrug
VincristineDrug
PirarubicinDrug
CyclophosphamideDrug
L-asparaginaseDrug
CytarabineDrug
HydrocortisoneDrug
MercaptopurineDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Methotrexate; Drug: Prednisolone; Drug: Dexamethasone; Drug: Vincristine; Drug: Pirarubicin; Drug: Cyclophosphamide; Drug: L-asparaginase; Drug: Cytarabine; Drug: Hydrocortisone; Drug: Mercaptopurine |
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 (1)
The rate of complete remission
Measured: 3 years
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 completionMay 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT00131053
- Sponsor's protocol ID
- JALSG ALL202-U
- 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
- Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00131053
- Acronym / sponsor ID
- JALSG ALL202-U
- Conditions
- Lymphoblastic Leukemia, Acute
- Keywords
- acute lymphoblastic leukemia, newly diagnosed, BCR-ABL-negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Japan Adult Leukemia Study GroupUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- May 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 efficacy and safety for treating adult ALL patients with the pediatric protocol.
Detailed description
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Methotrexate, Drug: Prednisolone, Drug: Dexamethasone, Drug: Vincristine, Drug: Pirarubicin, Drug: Cyclophosphamide, Drug: L-asparaginase, Drug: Cytarabine, Drug: Hydrocortisone, Drug: Mercaptopurine |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Previously untreated BCR-ABL-negative ALL
- Age between 15 and 24 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 |
|---|---|---|
| Methotrexate | Drug | A |
| Prednisolone | Drug | A |
| Dexamethasone | Drug | A |
| Vincristine | Drug | A |
| Pirarubicin | Drug | A |
| Cyclophosphamide | Drug | A |
| L-asparaginase | Drug | A |
| Cytarabine | Drug | A |
| Hydrocortisone | Drug | A |
| Mercaptopurine | Drug | A |
Primary outcome
Disease-free survival
Time frame: 3 years
1 secondary outcome
The rate of complete remission
Time frame: 3 years
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 2 study testing Methotrexate, Prednisolone and Dexamethasone 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 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?
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.