Philadelphia Positive Acute Lymphoblastic LeukemiaPhase 2NCT00199186
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study testing imatinib, vincristine and cyclophosphamide in people with Philadelphia Positive Acute Lymphoblastic Leukemia and Lymphoid Blastic Phase of Chronic Myeloid Leukemia, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether… Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
- What is being tested?
- imatinib, vincristine and cyclophosphamide
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Mar 2002to not given
- 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 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients
- Age > 55 years (biological age)
- Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL)
- Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia
- Only pre-phase chemotherapy prior to study start
- World Health Organization (WHO) status 0, 1 or 2
- Voluntary written informed consent
Who cannot join
- Creatinine levels more than 2 x the upper limit of normal (ULN)
- Total serum bilirubin more than 1.5 x the ULN
- AST (SGOT) or ALT (SGPT) more than 5 x the ULN
- Any other prior antineoplastic treatment except for pre-phase chemotherapy
- Active central nervous system (CNS) leukemia
- New York Heart Association (NYHA) grade 3/4 cardiac disease
Show all 9Show fewer
- Active severe infection
- Serious concomitant medical condition
- Patients with a history of non-compliance to medical regimens
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Frankfurt am Main, 60590
Oliver G Ottmann, M.D., ++49-69-6301-0 ext. 6221, ottmann@em.uni-frankfurt.de
About this study
Official title: A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)
The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.
- Conditions
- Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
- Being tested
- imatinib, vincristine, cyclophosphamide, cytosine arabinoside, dexamethasone
- 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.
imatinibDrug
vincristineDrug
cyclophosphamideDrug
cytosine arabinosideDrug
dexamethasoneDrug
idarubicinDrug
methotrexate (intrathecal)Drug
AraC (intrathecal)Drug
dexamethasone (intrathecal)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate after induction therapy
Secondary outcomes (9)
Mortality rate during induction
Severe adverse events during induction
Efficacy of salvage therapy after crossover
Levels of minimal residual disease
Incidence of relapse
Remission duration
Disease free survival
Overall survival
Frequency of point mutations in the BCR-ABL gene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Positive 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Oliver G Ottmann, M.D., Study chair, Medizinische Klinik II, Johann Wolfgang Goethe Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199186
- Sponsor's protocol ID
- CSTI571ADE10
- Other IDs
- GMALL-STI571-ELDERLY-01/02
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 19 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT00199186
- Acronym / sponsor ID
- CSTI571ADE10
- Conditions
- Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2002
- First posted
- 20 Sep 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 aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients
- Age > 55 years (biological age)
- Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL)
- Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia
- Only pre-phase chemotherapy prior to study start
Key exclusion criteria (9 listed)
- Creatinine levels more than 2 x the upper limit of normal (ULN)
- Total serum bilirubin more than 1.5 x the ULN
- AST (SGOT) or ALT (SGPT) more than 5 x the ULN
- Any other prior antineoplastic treatment except for pre-phase chemotherapy
- Active central nervous system (CNS) leukemia
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 | – |
| vincristine | Drug | – |
| cyclophosphamide | Drug | – |
| cytosine arabinoside | Drug | – |
| dexamethasone | Drug | – |
| idarubicin | Drug | – |
| methotrexate (intrathecal) | Drug | – |
| AraC (intrathecal) | Drug | – |
| dexamethasone (intrathecal) | Drug | – |
Primary outcome
Remission rate after induction therapy
9 secondary outcomes
Mortality rate during induction
Severe adverse events during induction
Efficacy of salvage therapy after crossover
Levels of minimal residual disease
Incidence of relapse
Remission duration
Disease free survival
Overall survival
Frequency of point mutations in the BCR-ABL gene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2007.
Related trials for Philadelphia Positive Acute Lymphoblastic Leukemia
RecruitingPhase 1
A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)
Philadelphia Positive Acute Lymphoblastic Leukemia
RecruitingPhase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, Recurrent B Acute Lymphoblastic Leukemia
RecruitingPhase 2
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
B Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia
RecruitingPhase 1
Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
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.
Oliver G Ottmann, M.D. study chair
Medizinische Klinik II, Johann Wolfgang Goethe Universität
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, vincristine and cyclophosphamide in people with Philadelphia Positive Acute Lymphoblastic Leukemia and Lymphoid Blastic Phase of Chronic Myeloid Leukemia, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 9 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 19 Oct 2007. 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 Germany. 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 Oliver G Ottmann, M.D. (++49-69-6301-0 ext. 6221, ottmann@em.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate after induction therapy. 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 19 Oct 2007.