Adult Acute Lymphocytic LeukemiaPhase 4NCT00199004
Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
A Phase 4 study testing Cyclophosphamide, Dexamethasone / Prednisolone and Vincristine in people with Adult Acute Lymphocytic Leukemia, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Adult Acute Lymphocytic Leukemia
- What is being tested?
- Cyclophosphamide, Dexamethasone / Prednisolone and Vincristine
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2004to Mar 2009
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- B-precursor ALL (common / pre B-ALL)
- Standard risk
- CD20 expression >20%
- Ph/BCR-ABL negative
- Age 15-65 years (55-65 if biologically younger)
- Written informed consent
Who cannot join
- Severe complications due to leukemia or secondary illnesses
- Late relapse of childhood ALL
- Cytostatic pretreatment
- Pregnancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
- Known severe allergy to foreign proteins
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Frankfurt, Medical Dept. II
Frankfurt, 60590
About this study
Official title: German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation
- Conditions
- Adult Acute Lymphocytic Leukemia
- Being tested
- Cyclophosphamide, Dexamethasone / Prednisolone, Vincristine, Daunorubicin, Asparaginase
- Keywords
- ALL, Treatment, De novo, Minimal residual disease, Rituximab, Adult
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Dexamethasone / PrednisoloneDrug
VincristineDrug
DaunorubicinDrug
AsparaginaseDrug
MethotrexateDrug
CytarabineDrug
MercaptopurineDrug
G-CSFDrug
VindesineDrug
VP16Drug
AdriamycinDrug
ThioguanineDrug
VM26Drug
RituximabDrug
CNS irradiationProcedure or surgery
Mediastinal irradiation (if residual TU)Procedure or surgery
Stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
Secondary outcomes (1)
Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
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 startApr 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Lymphocytic 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dieter Hoelzer, MD,PhD, Study chair, University Hospital, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199004
- Sponsor's protocol ID
- GMALL03
- Status last verified
- May 2008
- First submitted
- 12 Sep 2005
- Last updated
- 23 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)
- ClinicalTrials.gov ID
- NCT00199004
- Acronym / sponsor ID
- GMALL03
- Conditions
- Adult Acute Lymphocytic Leukemia
- Keywords
- ALL, Treatment, De novo, Minimal residual disease, Rituximab, Adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- 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 study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- B-precursor ALL (common / pre B-ALL)
- Standard risk
- CD20 expression >20%
- Ph/BCR-ABL negative
- Age 15-65 years (55-65 if biologically younger)
Key exclusion criteria (6 listed)
- Severe complications due to leukemia or secondary illnesses
- Late relapse of childhood ALL
- Cytostatic pretreatment
- Pregnancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
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 | – |
| Dexamethasone / Prednisolone | Drug | – |
| Vincristine | Drug | – |
| Daunorubicin | Drug | – |
| Asparaginase | Drug | – |
| Methotrexate | Drug | – |
| Cytarabine | Drug | – |
| Mercaptopurine | Drug | – |
| G-CSF | Drug | – |
| Vindesine | Drug | – |
| VP16 | Drug | – |
| Adriamycin | Drug | – |
| Thioguanine | Drug | – |
| VM26 | Drug | – |
| Rituximab | Drug | – |
| CNS irradiation | Procedure or surgery | – |
| Mediastinal irradiation (if residual TU) | Procedure or surgery | – |
| Stem cell transplantation | Procedure or surgery | – |
Primary outcome
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
1 secondary outcome
Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
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 23 Aug 2010.
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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.
Dieter Hoelzer, MD,PhD study chair
University Hospital, Medical Dept. II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclophosphamide, Dexamethasone / Prednisolone and Vincristine in people with Adult Acute Lymphocytic 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 6 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 23 Aug 2010. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival. 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 23 Aug 2010.