LymphomaPhase 2/3NCT00536393
Treatment of Disseminated High Grade Lymphoma
A Phase 2/3 study testing Doxorubicin and Doxorubicin pegylated in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
Interest of the use of pegylated liposomal doxorubicin (caélyx) Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Doxorubicin and Doxorubicin pegylated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2000to Oct 2004
- Phase
- Phase 2/3
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high grade lymphoma
- disseminated
- > 60 years old and < 75
- informed consent signed
- cardiac state compatible with antracyclin
- ECOG </= 2
Who cannot join
- patients > 75 years old
- Cardiac insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)
Interest of the use of pegylated liposomal doxorubicin (caélyx)
Read the detailed description
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.
- Conditions
- Lymphoma
- Being tested
- Doxorubicin, Doxorubicin pegylated
- Keywords
- diffuse larg cells lymphoma, chemotherapy, toxicity, diffuse high grade lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Doxorubicin pegylatedDrug
| Study group | Role | What they receive |
|---|---|---|
| Doxorubicine | Active comparator | CHOP 8 courses every 21 days Receives: Drug: Doxorubicin |
| Doxorubicine pegylated | Experimental | CLOP 8 courses every 21 days Receives: Drug: Doxorubicin pegylated |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematologic toxicity
Measured: 6 months
Secondary outcomes (3)
response rate
Measured: 6 months
EFS and OS
Measured: 6 months
Cardiac toxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startOct 2000
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Investigators
- Guillaume CARTRON, Dr, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536393
- Sponsor's protocol ID
- GOELAMS 0804
- Status last verified
- Sep 2007
- First submitted
- 26 Sep 2007
- Last updated
- 1 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)
- ClinicalTrials.gov ID
- NCT00536393
- Acronym / sponsor ID
- GOELAMS 0804
- Conditions
- Lymphoma
- Keywords
- diffuse larg cells lymphoma, chemotherapy, toxicity, diffuse high grade lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- Oct 2000
- Study completion
- Oct 2004 (actual)
- First posted
- 27 Sep 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.
Interest of the use of pegylated liposomal doxorubicin (caélyx)
Detailed description
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxorubicine | Active comparator | Drug: DoxorubicinCHOP 8 courses every 21 days |
| Doxorubicine pegylated | Experimental | Drug: Doxorubicin pegylatedCLOP 8 courses every 21 days |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- high grade lymphoma
- disseminated
- > 60 years old and < 75
- informed consent signed
- cardiac state compatible with antracyclin
Key exclusion criteria (2 listed)
- patients > 75 years old
- Cardiac insufficiency
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 |
|---|---|---|
| Doxorubicin | Drug | Doxorubicine |
| Doxorubicin pegylated | Drug | Doxorubicine pegylated |
Primary outcome
hematologic toxicity
Time frame: 6 months
3 secondary outcomes
response rate
Time frame: 6 months
EFS and OS
Time frame: 6 months
Cardiac toxicity
Time frame: 6 months
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 1 Nov 2007.
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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.
Guillaume CARTRON, Dr principal investigator
French Innovative Leukemia Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Doxorubicin and Doxorubicin pegylated in people with Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
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 6 inclusion and 2 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 1 Nov 2007. 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
hematologic toxicity (time frame: 6 months). 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 1 Nov 2007.