Acute Lymphoblastic LeukemiaPhase 2NCT00130195
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study testing imatinib, cyclophosphamide and daunorubicin in people with Acute Lymphoblastic Leukemia, run by Japan Adult Leukemia Study Group at 1 site in Japan.
Trial summary
The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL. Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- imatinib, cyclophosphamide and daunorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2002to May 2008
- 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 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Previously untreated BCR-ABL-positive ALL
- Age between 15 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.
Japan1 site
Department of Hematology, Nagoya University Graduate School of Medicine
Nagoya, 466-8550
About this study
Official title: Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia
The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
Read the detailed description
Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- imatinib, cyclophosphamide, daunorubicin, vincristine, prednisolone
- Keywords
- acute lymphoblastic leukemia, BCR-ABL, Philadelphia-chromosome, newly diagnosed
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinibDrug
cyclophosphamideDrug
daunorubicinDrug
vincristineDrug
prednisoloneDrug
methotrexateDrug
cytarabineDrug
dexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: imatinib; Drug: cyclophosphamide; Drug: daunorubicin; Drug: vincristine; Drug: prednisolone; Drug: methotrexate; Drug: cytarabine; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of complete remission
Measured: 63 days
Secondary outcomes (3)
The duration of remission
Measured: 1 year
Overall survival
Measured: 1 year
Toxicity caused by combination of imatinib and chemotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startSep 2002
- Primary completionFeb 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- 100 participants (actual)
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
- NCT00130195
- Sponsor's protocol ID
- JALSG Ph+ALL202
- Status last verified
- Nov 2008
- First submitted
- 12 Aug 2005
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Towatari M, Yanada M, Usui N, Takeuchi J, Sugiura I, Takeuchi M, Yagasaki F, Kawai Y, Miyawaki S, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Combination of intensive chemotherapy and imatinib can rapidly induce high-quality complete remission for a majority of patients with newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia. Blood. 2004 Dec 1;104(12):3507-12. doi: 10.1182/blood-2004-04-1389. Epub 2004 Aug 17.
PubMed 15315963Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Kobayashi T, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Emi N, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. High complete remission rate and promising outcome by combination of imatinib and chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia: a phase II study by the Japan Adult Leukemia Study Group. J Clin Oncol. 2006 Jan 20;24(3):460-6. doi: 10.1200/JCO.2005.03.2177. Epub 2005 Dec 12.
PubMed 16344315Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Nishii K, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Narimatsu H, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Karyotype at diagnosis is the major prognostic factor predicting relapse-free survival for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with imatinib-combined chemotherapy. Haematologica. 2008 Feb;93(2):287-90. doi: 10.3324/haematol.11891. Epub 2008 Jan 26.
PubMed 18223280
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 Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00130195
- Acronym / sponsor ID
- JALSG Ph+ALL202
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- acute lymphoblastic leukemia, BCR-ABL, Philadelphia-chromosome, newly diagnosed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Japan Adult Leukemia Study GroupUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 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 determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
Detailed description
Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
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: imatinib, Drug: cyclophosphamide, Drug: daunorubicin, Drug: vincristine, Drug: prednisolone, Drug: methotrexate, Drug: cytarabine, Drug: dexamethasone |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Previously untreated BCR-ABL-positive ALL
- Age between 15 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 |
|---|---|---|
| imatinib | Drug | A |
| cyclophosphamide | Drug | A |
| daunorubicin | Drug | A |
| vincristine | Drug | A |
| prednisolone | Drug | A |
| methotrexate | Drug | A |
| cytarabine | Drug | A |
| dexamethasone | Drug | A |
Primary outcome
The rate of complete remission
Time frame: 63 days
3 secondary outcomes
The duration of remission
Time frame: 1 year
Overall survival
Time frame: 1 year
Toxicity caused by combination of imatinib and chemotherapy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- Results publication: PubMed 15315963Towatari M, Yanada M, Usui N, Takeuchi J, Sugiura I, Takeuchi M, Yagasaki F, Kawai Y, Miyawaki S, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Combination of intensive chemotherapy and imatinib can rapidly induce high-quality complete remission for a majority of patients with newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia. Blood. 2004 Dec 1;104(12):3507-12. doi: 10.1182/blood-2004-04-1389. Epub 2004 Aug 17.
- Results publication: PubMed 16344315Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Kobayashi T, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Emi N, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. High complete remission rate and promising outcome by combination of imatinib and chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia: a phase II study by the Japan Adult Leukemia Study Group. J Clin Oncol. 2006 Jan 20;24(3):460-6. doi: 10.1200/JCO.2005.03.2177. Epub 2005 Dec 12.
- Results publication: PubMed 18223280Yanada M, Takeuchi J, Sugiura I, Akiyama H, Usui N, Yagasaki F, Nishii K, Ueda Y, Takeuchi M, Miyawaki S, Maruta A, Narimatsu H, Miyazaki Y, Ohtake S, Jinnai I, Matsuo K, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Karyotype at diagnosis is the major prognostic factor predicting relapse-free survival for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with imatinib-combined chemotherapy. Haematologica. 2008 Feb;93(2):287-90. doi: 10.3324/haematol.11891. Epub 2008 Jan 26.
- 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 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 imatinib, cyclophosphamide and daunorubicin in people with Acute Lymphoblastic Leukemia, 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of complete remission (time frame: 63 days). 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 NCT00130195, which also lists 3 linked publications.
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.