LymphomaNCT00517894
Dose-Dense Therapy in Aggressive Lymphoma
A study testing CEOP/IMVP-Dexa chemotherapy in people with Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Trial summary
To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CEOP/IMVP-Dexa chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 18 and 70 years of age
- Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified
- Measurable disease
- All stages
Who cannot join
- Lymphoblastic or Burkitt histology
- CNS-disease
- HIV-positive
- pregnant or lactating women
- Pretreatment
- Other malignancy
- Concomitant diseases that forbid chemotherapy
About this study
Official title: Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma
To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.
Read the detailed description
Patients are randomized to receive dose-dense CEOP/IMVP-Dexa chemotherapy or standard 3-weekly CHOP.
- Conditions
- Lymphoma
- Being tested
- CEOP/IMVP-Dexa chemotherapy
- Keywords
- lymphoma, aggressive, chemotherapy, dose-dense
- Medical subject headings
- Lymphoma, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEOP/IMVP-Dexa chemotherapyDrug
Cyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
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 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517894
- Sponsor's protocol ID
- NHL-5
- Status last verified
- Aug 2007
- First submitted
- 15 Aug 2007
- Last updated
- 17 Aug 2007
- Results posted
- No
Publications
Fridrik MA, Hausmaninger H, Lang A, Drach J, Krieger O, Geissler D, Michlmayr G, Ulsperger E, Chott A, Oberaigner W, Greil R. Dose-dense therapy improves survival in aggressive non-Hodgkin's lymphoma. Ann Hematol. 2010 Mar;89(3):273-82. doi: 10.1007/s00277-009-0811-x. Epub 2009 Aug 20.
PubMed 19693500
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00517894
- Acronym / sponsor ID
- NHL-5
- Conditions
- Lymphoma
- Keywords
- lymphoma, aggressive, chemotherapy, dose-dense
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- First posted
- 17 Aug 2007 (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.
To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.
Detailed description
Patients are randomized to receive dose-dense CEOP/IMVP-Dexa chemotherapy or standard 3-weekly CHOP.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 and 70 years of age
- Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified
- Measurable disease
- All stages
Key exclusion criteria (7 listed)
- Lymphoblastic or Burkitt histology
- CNS-disease
- HIV-positive
- pregnant or lactating women
- Pretreatment
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 |
|---|---|---|
| CEOP/IMVP-Dexa chemotherapyCyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2007.
- Derived from this study: PubMed 19693500Fridrik MA, Hausmaninger H, Lang A, Drach J, Krieger O, Geissler D, Michlmayr G, Ulsperger E, Chott A, Oberaigner W, Greil R. Dose-dense therapy improves survival in aggressive non-Hodgkin's lymphoma. Ann Hematol. 2010 Mar;89(3):273-82. doi: 10.1007/s00277-009-0811-x. Epub 2009 Aug 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CEOP/IMVP-Dexa chemotherapy in people with Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00517894, 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 17 Aug 2007.