Adult Acute Lymphocytic LeukemiaPhase 4NCT00199069
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
A Phase 4 study testing Asparaginase, Vincristine and Daunorubicin, Adriamycin in people with Adult Acute Lymphocytic Leukemia, run by Goethe University at 1 site in Germany.
Trial summary
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL', 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?
- Asparaginase, Vincristine and Daunorubicin, Adriamycin
- Type of treatment
- Surgery or procedure
- How many people
- 720 participants
- Where
- 1 siteGermany
- Study dates
- Apr 1993to May 2001
- 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
- Acute Lymphocytic Leukemia
- Age 15 - 65 years
Who cannot join
- Serious secondary diseases which may compromise intensified chemotherapeutical treatment
- Serious psychiatric diseases, which may compromise compliance with therapy
- HIV-1 or HIV-2 Infection
- Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
- Patients without central diagnosis who cannot be allocated to a risk group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',
- Conditions
- Adult Acute Lymphocytic Leukemia
- Being tested
- Asparaginase, Vincristine, Daunorubicin, Adriamycin, Cyclophosphamide, Ifosfamide
- Keywords
- ALL, Treatment, De Novo, Adult
- 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.
AsparaginaseDrug
VincristineDrug
Daunorubicin, AdriamycinDrug
CyclophosphamideDrug
IfosfamideDrug
CytarabineDrug
MitoxantroneDrug
MethotrexateDrug
6-MercaptopurineDrug
6-ThioguanineDrug
VM26Drug
Dexamethasone / PrednisoloneDrug
CNS IrradiationProcedure or surgery
Mediastinal IrradiationProcedure 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, disease free survival, overall survival
Secondary outcomes (1)
death in induction, toxicity, time and dose compliance
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 1993
- Primary completionJan 1999
- Study completionMay 2001
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Responsible party
- Principal investigator, Nicola Goekbuget, Goethe University
- Investigators
- Dieter Hoelzer, MD, PhD, Study chair, University of Frankfurt, Medical Department II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199069
- Sponsor's protocol ID
- GMALL09
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2005
- Last updated
- 17 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)
- ClinicalTrials.gov ID
- NCT00199069
- Acronym / sponsor ID
- GMALL09
- Conditions
- Adult Acute Lymphocytic Leukemia
- Keywords
- ALL, Treatment, De Novo, Adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany)
- Study start
- Apr 1993 (actual)
- Primary completion
- Jan 1999 (actual)
- Study completion
- May 2001 (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 a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (2 listed)
- Acute Lymphocytic Leukemia
- Age 15 - 65 years
Key exclusion criteria (5 listed)
- Serious secondary diseases which may compromise intensified chemotherapeutical treatment
- Serious psychiatric diseases, which may compromise compliance with therapy
- HIV-1 or HIV-2 Infection
- Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
- Patients without central diagnosis who cannot be allocated to a risk group
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 |
|---|---|---|
| Asparaginase | Drug | – |
| Vincristine | Drug | – |
| Daunorubicin, Adriamycin | Drug | – |
| Cyclophosphamide | Drug | – |
| Ifosfamide | Drug | – |
| Cytarabine | Drug | – |
| Mitoxantrone | Drug | – |
| Methotrexate | Drug | – |
| 6-Mercaptopurine | Drug | – |
| 6-Thioguanine | Drug | – |
| VM26 | Drug | – |
| Dexamethasone / Prednisolone | Drug | – |
| CNS Irradiation | Procedure or surgery | – |
| Mediastinal Irradiation | Procedure or surgery | – |
| Stem Cell Transplantation | Procedure or surgery | – |
Primary outcome
remission rate, disease free survival, overall survival
1 secondary outcome
death in induction, toxicity, time and dose compliance
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 17 Mar 2023.
Related trials for Adult Acute Lymphocytic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
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 of Frankfurt, Medical Department 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 Asparaginase, Vincristine and Daunorubicin, Adriamycin in people with Adult Acute Lymphocytic Leukemia, run by Goethe University 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 2 inclusion and 5 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 17 Mar 2023. 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, 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 17 Mar 2023.