High-Grade LymphomasPhase 3NCT00866203
HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
A Phase 3 study testing HDS vs ProMECE/CytaBOM in people with High-Grade Lymphomas, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial summary
The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High-Grade Lymphomas
- What is being tested?
- HDS vs ProMECE/CytaBOM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2000to Apr 2008
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, untreated patients with histologically documented aggressive lymphoma;
- Age between 18 and 65 years;
- Clinical stage at diagnosis: I A bulky - IV B;
- Reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%;
- Serum negativity for HIV, HbsAg and HCV;
- ECOG performance status 0 through 4;
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- Adequate bone marrow function;
- Adequate renal and hepatic functions;
- Left ventricular ejection fraction (LVEF) > 50%;
- No previous malignant disease;
- No previous chemo-radiotherapy;
- No cerebral or CNS involvement, assessed by clinical history, physical examination and CSF examination through lumbar puncture;
- Written informed consent given at time of randomization.
Who cannot join
- Clinical stage I no bulky, or CS IIA-B with less than three sites of disease involved;
- Patients with CR, unconfirmed complete remission (uCR), very good PR (>75%) and clinical response less than 50%, as defined by Cheson et al., following four courses of induction therapy;
- Tumor involvement of CNS (except patients with peridural masses without liquor involvement , who can be enrolled in this study);
- Indolent lymphoma transformed in more aggressive histologic type, even if never previously treated;
- Aggressive non-Hodgkin's lymphoma in pre-transplanted patient;
- Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure > 115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;
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- Left ventricular ejection fraction (LVEF) < 50%;
- Evidence of any severe active acute or chronic infection;
- Concurrent malignancy of history of other malignancy, except basal cell carcinoma of the skin (BCC) and in situ cervical carcinoma (CIN);
- myelodisplastic syndrome;
- HbsAg, HIV-positive, or HCV-RNA-positive patients;
- Patient with psychiatric, or any disorder that compromises ability to give truly informed consent for participation in this study;
- Pregnant woman; potential child-bearing women can be enrolled if adequate contraceptive precautions are used before entering this trial and for the duration of the trial;
- Concerns for patient's compliance with the protocol procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Multicenter Trial Comparing a Modified HDS Therapy Supported by PBPC Transplant With Additional 4 Courses of Front-Line Therapy in Adult Aggressive NHL With PR After Short Course of Up-Front Chemotherapy
The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program.
- Conditions
- High-Grade Lymphomas
- Being tested
- HDS vs ProMECE/CytaBOM
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDS vs ProMECE/CytaBOMDrug
| Study group | Role | What they receive |
|---|---|---|
| HDS | Experimental | modified high dose sequential therapy Receives: Drug: HDS vs ProMECE/CytaBOM |
| ProMECE/CytaBOM | Active comparator | four additional courses of standard ProMECE/CytaBOM Receives: Drug: HDS vs ProMECE/CytaBOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission duration
Measured: end of treatment
overall survival
Measured: study end
event-free survival
Measured: study end
freedom-from progression
Measured: study end
Secondary outcomes (1)
feasibility and toxicity
Measured: end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startOct 2000
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade LymphomasStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Investigators
- Nicola Di Renzo, MD, Principal investigator, GISLMassimo Federico, MD, Study chair, GISLMaura Brugiatelli, MD, Study chair, GISLMario Petrini, MD, Study chair, GISLPaolo G Gobbi, MD, Study chair, GISL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866203
- Sponsor's protocol ID
- LA05
- Status last verified
- Mar 2009
- First submitted
- 13 Mar 2007
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Trial Comparing a Modified HDS Therapy Supported by PBPC Transplant With Additional 4 Courses of Front-Line Therapy in Adult Aggressive NHL With PR After Short Course of Up-Front Chemotherapy
- ClinicalTrials.gov ID
- NCT00866203
- Acronym / sponsor ID
- LA05
- Conditions
- High-Grade Lymphomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Study start
- Oct 2000
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Mar 2009 (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 is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDS | Experimental | Drug: HDS vs ProMECE/CytaBOMmodified high dose sequential therapy |
| ProMECE/CytaBOM | Active comparator | Drug: HDS vs ProMECE/CytaBOMfour additional courses of standard ProMECE/CytaBOM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Newly diagnosed, untreated patients with histologically documented aggressive lymphoma;
- Age between 18 and 65 years;
- Clinical stage at diagnosis: I A bulky - IV B;
- Reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%;
- Serum negativity for HIV, HbsAg and HCV;
Key exclusion criteria (14 listed)
- Clinical stage I no bulky, or CS IIA-B with less than three sites of disease involved;
- Patients with CR, unconfirmed complete remission (uCR), very good PR (>75%) and clinical response less than 50%, as defined by Cheson et al., following four courses of induction therapy;
- Tumor involvement of CNS (except patients with peridural masses without liquor involvement , who can be enrolled in this study);
- Indolent lymphoma transformed in more aggressive histologic type, even if never previously treated;
- Aggressive non-Hodgkin's lymphoma in pre-transplanted patient;
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 |
|---|---|---|
| HDS vs ProMECE/CytaBOM | Drug | HDS, ProMECE/CytaBOM |
Primary outcome
remission duration
Time frame: end of treatment
overall survival
Time frame: study end
event-free survival
Time frame: study end
freedom-from progression
Time frame: study end
1 secondary outcome
feasibility and toxicity
Time frame: end of treatment
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 2009.
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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 Di Renzo, MD principal investigator
GISL
Massimo Federico, MD study chair
GISL
Maura Brugiatelli, MD study chair
GISL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDS vs ProMECE/CytaBOM in people with High-Grade Lymphomas, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
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 13 inclusion and 14 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 2009. 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 Italy. 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 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?
remission duration (time frame: end of treatment). 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?
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 2009.