Lymphoma, LymphoblasticPhase 4NCT00199017
German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults
A Phase 4 study testing Dexamethasone/Prednisolone, Cyclophosphamide and Vincristine in people with Lymphoma, Lymphoblastic, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Lymphoma, Lymphoblastic
- What is being tested?
- Dexamethasone/Prednisolone, Cyclophosphamide and Vincristine
- Type of treatment
- Surgery or procedure
- How many people
- 75 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
- T-lymphoblastic lymphoma (bone marrow [BM] involvement < 25%)
- Aged 15-65 years (55-65 years if biologically younger)
- Written informed consent
Who cannot join
- Severe complications due to lymphoma or secondary disease
- T-LBL as second malignancy or other active second malignancy
- Cytostatic pretreatment of LBL (exception of emergency treatments)
- Pregnancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
- Participation in other study interfering with study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.
- Conditions
- Lymphoma, Lymphoblastic
- Being tested
- Dexamethasone/Prednisolone, Cyclophosphamide, Vincristine, Daunorubicin, Asparaginase
- Keywords
- T-LBL, Treatment, De novo, Chemotherapy, Adult, Lymphoma, lymphoblastic, T-cell
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone/PrednisoloneDrug
CyclophosphamideDrug
VincristineDrug
DaunorubicinDrug
AsparaginaseDrug
G-CSFDrug
MercaptopurineDrug
CytarabineDrug
MethotrexateDrug
VP16Drug
VindesineDrug
AdriamycinDrug
ThioguanineDrug
HDARACDrug
CNS irradiationProcedure or surgery
Mediastinal irradiationProcedure or surgery
CladribineDrug
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 (1)
time and dose compliance, toxicity according to World Health Organization (WHO)
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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, LymphoblasticStudies 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
- 75 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 Frankfurt, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199017
- Sponsor's protocol ID
- GMALL04
- 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
- Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
- ClinicalTrials.gov ID
- NCT00199017
- Acronym / sponsor ID
- GMALL04
- Conditions
- Lymphoma, Lymphoblastic
- Keywords
- T-LBL, Treatment, De novo, Chemotherapy, Adult, Lymphoma, lymphoblastic, T-cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Primary 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.
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.
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 (3 listed)
- T-lymphoblastic lymphoma (bone marrow [BM] involvement < 25%)
- Aged 15-65 years (55-65 years if biologically younger)
- Written informed consent
Key exclusion criteria (6 listed)
- Severe complications due to lymphoma or secondary disease
- T-LBL as second malignancy or other active second malignancy
- Cytostatic pretreatment of LBL (exception of emergency treatments)
- 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 |
|---|---|---|
| Dexamethasone/Prednisolone | Drug | – |
| Cyclophosphamide | Drug | – |
| Vincristine | Drug | – |
| Daunorubicin | Drug | – |
| Asparaginase | Drug | – |
| G-CSF | Drug | – |
| Mercaptopurine | Drug | – |
| Cytarabine | Drug | – |
| Methotrexate | Drug | – |
| VP16 | Drug | – |
| Vindesine | Drug | – |
| Adriamycin | Drug | – |
| Thioguanine | Drug | – |
| HDARAC | Drug | – |
| CNS irradiation | Procedure or surgery | – |
| Mediastinal irradiation | Procedure or surgery | – |
| Cladribine | Drug | – |
Primary outcome
remission rate, remission duration, disease free survival, overall survival
1 secondary outcome
time and dose compliance, toxicity according to World Health Organization (WHO)
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 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 Dexamethasone/Prednisolone, Cyclophosphamide and Vincristine in people with Lymphoma, Lymphoblastic, 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 3 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, 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.