Adult Acute Lymphocytic LeukemiaPhase 4NCT00198978
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase 4 study testing Cyclophosphamide, Dexamethasone / Prednisolone and Cytarabine 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 dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Adult Acute Lymphocytic Leukemia
- What is being tested?
- Cyclophosphamide, Dexamethasone / Prednisolone and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Jun 2014
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
- Age > 55 yrs (no upper age limit)
- Written informed consent
Who cannot join
- Severe leukemia associated complications, not controllable before therapy onset e.g.
- life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
- Severe comorbidity e.g.
- decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
- heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
- hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin > 1,5 x ULN and/or ASA, ALA, AP > 2,5 ULN
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- decompensated metabolic disturbances (e.g. not controllable diabetes)
- severe obstructive or restrictive pulmonary disease with hypoxaemia
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
- Active second neoplasia
- HIV infection
- Severely reduced general condition
- Cytostatic pre-treatment of ALL
- Chemotherapy treatment of any other malignancy during the last 5 years
- Participation in other clinical trials interfering with the study therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
- Conditions
- Adult Acute Lymphocytic Leukemia
- Being tested
- Cyclophosphamide, Dexamethasone / Prednisolone, Cytarabine, Idarubicin, Granulocyte-Colony-Stimulating Factor
- Keywords
- ALL, Treatment, Elderly, De novo
- 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.
CyclophosphamideDrug
Dexamethasone / PrednisoloneDrug
CytarabineDrug
IdarubicinDrug
Granulocyte-Colony-Stimulating FactorDrug
MercaptopurineDrug
MethotrexateDrug
RituximabDrug
HDARACDrug
VincristineDrug
DepocyteDrug
AsparaginaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Not described Receives: Drug: Cyclophosphamide; Drug: Dexamethasone / Prednisolone; Drug: Cytarabine; Drug: Idarubicin; Drug: Granulocyte-Colony-Stimulating Factor; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Rituximab; Drug: HDARAC; Drug: Vincristine; Drug: Depocyte; Drug: Asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate (cytologic, molecular)
Measured: After induction; approximately 6 wks (exact time frame not specified)
Toxicity (CTC)
Measured: After each cycle; time-frame not specified
Survival time, Duration of Remission
Measured: at 3 and 5 years
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 startJan 2003
- Primary completionJun 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Goekbuget, Goethe University
- Investigators
- Dieter Hoelzer, MD,PhD, Study chair, University of Frankfurt, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198978
- Sponsor's protocol ID
- GMALL02
- Status last verified
- Mar 2023
- First submitted
- 12 Sep 2005
- Last updated
- 20 Mar 2023
- Results posted
- No
Publications
Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.
PubMed 23024237
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
- ClinicalTrials.gov ID
- NCT00198978
- Acronym / sponsor ID
- GMALL02
- Conditions
- Adult Acute Lymphocytic Leukemia
- Keywords
- ALL, Treatment, Elderly, De novo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jan 2003 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2014 (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 dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Drug: Cyclophosphamide, Drug: Dexamethasone / Prednisolone, Drug: Cytarabine, Drug: Idarubicin, Drug: Granulocyte-Colony-Stimulating Factor, Drug: Mercaptopurine, Drug: Methotrexate, Drug: Rituximab, Drug: HDARAC, Drug: Vincristine, Drug: Depocyte, Drug: Asparaginase |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
- Age > 55 yrs (no upper age limit)
- Written informed consent
Key exclusion criteria (15 listed)
- Severe leukemia associated complications, not controllable before therapy onset e.g.
- life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
- Severe comorbidity e.g.
- decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
- heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
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 | Interventional arm |
| Dexamethasone / Prednisolone | Drug | Interventional arm |
| Cytarabine | Drug | Interventional arm |
| Idarubicin | Drug | Interventional arm |
| Granulocyte-Colony-Stimulating Factor | Drug | Interventional arm |
| Mercaptopurine | Drug | Interventional arm |
| Methotrexate | Drug | Interventional arm |
| Rituximab | Drug | Interventional arm |
| HDARAC | Drug | Interventional arm |
| Vincristine | Drug | Interventional arm |
| Depocyte | Drug | Interventional arm |
| Asparaginase | Drug | Interventional arm |
Primary outcome
Remission rate (cytologic, molecular)
Time frame: After induction; approximately 6 wks (exact time frame not specified)
Toxicity (CTC)
Time frame: After each cycle; time-frame not specified
Survival time, Duration of Remission
Time frame: at 3 and 5 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 20 Mar 2023.
- Derived from this study: PubMed 23024237Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.
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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 of Frankfurt, 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 Cytarabine 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 3 inclusion and 15 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 20 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 (cytologic, molecular) (time frame: After induction; approximately 6 wks (exact time frame not specified)). The study lists 3 primary outcomes in all. 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 NCT00198978, which also lists 1 linked publication.
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 20 Mar 2023.