Burkitt's LymphomaPhase 4NCT00199082
Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
A Phase 4 study testing Adriamycin, Cyclophosphamide and Cytarabine in people with Burkitt's Lymphoma and Burkitt's Leukemia, run by Nicola Goekbuget at 1 site in Germany.
Trial summary
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Burkitt's Lymphoma, Burkitt's Leukemia, Mediastinal Neoplasms
- What is being tested?
- Adriamycin, Cyclophosphamide and Cytarabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2002to Jun 2010
- 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
- Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
- Age > 15 years
- Written informed consent
Who cannot join
- Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
- HIV infection
- Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
- Known severe allergy to foreign proteins
- Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
- Pregnancy or nursing
- Participation in other studies that interfere with study therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
- Conditions
- Burkitt's Lymphoma, Burkitt's Leukemia, Mediastinal Neoplasms, Lymphoblastic Lymphoma, Large Cell Anaplastic Lymphoma
- Being tested
- Adriamycin, Cyclophosphamide, Cytarabine, Dexamethasone/Prednisolone, VP16
- Keywords
- High-grade NHL, De novo, Mature B-ALL, Burkitt'S NHL, Chemotherapy, Rituximab, Primary mediastinal diffuse large cell lymphoma, B-precursor lymphoblastic lymphoma
- Medical subject headings
- Burkitt Lymphoma, Mediastinal Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdriamycinDrug
CyclophosphamideDrug
CytarabineDrug
Dexamethasone/PrednisoloneDrug
VP16Drug
IfosfamideDrug
MethotrexateDrug
G-CSFDrug
RituximabDrug
Vincristine/VindesineDrug
Irradiation (in specific conditions)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement Receives: Drug: Adriamycin; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone/Prednisolone; Drug: VP16; Drug: Ifosfamide; Drug: Methotrexate; Drug: G-CSF; Drug: Rituximab; Drug: Vincristine/Vindesine; Procedure: Irradiation (in specific conditions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate
Remission duration
Disease free survival
Overall survival
Secondary outcomes (4)
Dose and time compliance
Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
Death under therapy and in complete remission (CR)
Localisations of relapse
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 startJul 2002
- Primary completionJun 2010
- Study completionJun 2010
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 Burkitt's LymphomaStudies 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
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicola Goekbuget
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicola Goekbuget, Goethe University
- Investigators
- Nicola Goekbuget, Dr. med., Principal investigator, University Hospital of Frankfurt (Main)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199082
- Sponsor's protocol ID
- GMALL05
- Status last verified
- Aug 2022
- First submitted
- 12 Sep 2005
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hoelzer D, Walewski J, Dohner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Duhrsen U, Huttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gokbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. doi: 10.1182/blood-2014-03-563627. Epub 2014 Oct 30.
PubMed 25359988
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
- ClinicalTrials.gov ID
- NCT00199082
- Acronym / sponsor ID
- GMALL05
- Conditions
- Burkitt's Lymphoma, Burkitt's Leukemia, Mediastinal Neoplasms, Lymphoblastic Lymphoma, Large Cell Anaplastic Lymphoma
- Keywords
- High-grade NHL, De novo, Mature B-ALL, Burkitt'S NHL, Chemotherapy, Rituximab, Primary mediastinal diffuse large cell lymphoma, B-precursor lymphoblastic lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Nicola GoekbugetUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (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 alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Adriamycin, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Dexamethasone/Prednisolone, Drug: VP16, Drug: Ifosfamide, Drug: Methotrexate, Drug: G-CSF, Drug: Rituximab, Drug: Vincristine/Vindesine, Procedure: Irradiation (in specific conditions)This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
- Age > 15 years
- Written informed consent
Key exclusion criteria (7 listed)
- Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
- HIV infection
- Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
- Known severe allergy to foreign proteins
- Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
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 |
|---|---|---|
| Adriamycin | Drug | Experimental |
| Cyclophosphamide | Drug | Experimental |
| Cytarabine | Drug | Experimental |
| Dexamethasone/Prednisolone | Drug | Experimental |
| VP16 | Drug | Experimental |
| Ifosfamide | Drug | Experimental |
| Methotrexate | Drug | Experimental |
| G-CSF | Drug | Experimental |
| Rituximab | Drug | Experimental |
| Vincristine/Vindesine | Drug | Experimental |
| Irradiation (in specific conditions) | Procedure or surgery | Experimental |
Primary outcome
Remission rate
Remission duration
Disease free survival
Overall survival
4 secondary outcomes
Dose and time compliance
Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
Death under therapy and in complete remission (CR)
Localisations of relapse
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 19 Aug 2022.
- Results publication: PubMed 25359988Hoelzer D, Walewski J, Dohner H, Viardot A, Hiddemann W, Spiekermann K, Serve H, Duhrsen U, Huttmann A, Thiel E, Dengler J, Kneba M, Schaich M, Schmidt-Wolf IG, Beck J, Hertenstein B, Reichle A, Domanska-Czyz K, Fietkau R, Horst HA, Rieder H, Schwartz S, Burmeister T, Gokbuget N; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Improved outcome of adult Burkitt lymphoma/leukemia with rituximab and chemotherapy: report of a large prospective multicenter trial. Blood. 2014 Dec 18;124(26):3870-9. doi: 10.1182/blood-2014-03-563627. Epub 2014 Oct 30.
- Individual participant dataSharing planned: No
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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.
Nicola Goekbuget, Dr. med. principal investigator
University Hospital of Frankfurt (Main)
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 Adriamycin, Cyclophosphamide and Cytarabine in people with Burkitt's Lymphoma and Burkitt's Leukemia, run by Nicola Goekbuget 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 7 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 19 Aug 2022. 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. The study lists 4 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 NCT00199082, 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 19 Aug 2022.