Hodgkin LymphomaPhase 2NCT00392314
Tailored Therapy for Hodgkin Lymphoma Using Early Interim Therapy PET for Therapy Decision.
A Phase 2 study testing PET/CT post 2 cycles of chemotherapy in people with Hodgkin Lymphoma, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- PET/CT post 2 cycles of chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2006to May 2014
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hodgkin lymphoma patients
- age 18-60 for those with early disease and advanced disease with score less then 3
- age 18-60 years for patients with advanced disease score 3 or higher classical Hodgkin lymphoma
- WBC more then 3500
- platelets more then 100000
- creatinin less then 2.0 mg
- bilirubin less then 2.0 mg
- absolute neutrophil count more then 1000 unless bone marrow involvement If marrow involve, patient with lower count but ANC of 1000 may be included.
Who cannot join
- Positive serology for HIV
- bilirubin more then 2 mg/dl
- creatinin more then 2 mg/dl
- lactating woman or pregnant
- patient older then 60 years with high risk disease of score 3 or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study.Tailored Therapy for Hodgkin Lymphoma Based on Predefined Risk Factors and Early Interim PET/CT for Response Assessment and Further Therapy Decisions.
Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. These findings strongly support the integration of interim PET as a decision point for adjustment of chemotherapy.This study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative PET. Those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.
Read the detailed description
study aim is to tailor the therapy in order to administer the lowest cumulative dose of therapy yet considered safe in order to reduce both early and late therapy related complications.
patients will be divided according to risk factors to sub groups of early favorable, early unfavorable, advanced disease with score less then 3 points or higher then 3 points.
Early Interim PET will be carried out Further therapy will be based on the study results.
- Conditions
- Hodgkin Lymphoma
- Being tested
- PET/CT post 2 cycles of chemotherapy
- Keywords
- hodgkin lymphoma, PET/CT, Therapy
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT post 2 cycles of chemotherapyOther
Also called F18 deoxyglucose scintigraphy
sintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Early favorable | Experimental | patients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD Receives: Other: PET/CT post 2 cycles of chemotherapy |
| Early Unfavorable | Experimental | Patients with early favorable disease Ia or IIa with risk factors :large mediastinal mass extra nodal disease elevated esr, three or more involved areas, age equal or >50 , lymphocytic depleted or mixed cellularity Receives: Other: PET/CT post 2 cycles of chemotherapy |
| advanced disease | Experimental | patients with advanced disease low IPS score 0-2 will start chemotherapy with ABVD for 2 cycles followed by PET/CT further therapy will be given according to PET/CT results Receives: Other: PET/CT post 2 cycles of chemotherapy |
| advanced disease IPS 3-7 | Experimental | Patients with advanced disease IPS score 3-7 will start chemotherapy with escalated beacopp. following 2 cycles PET/CT will be carried out and according to results further chemotherapy will be given Receives: Other: PET/CT post 2 cycles of chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free survival in various risk groups of patients
Measured: five years
Event Free Survival
Measured: 5 years
Secondary outcomes (3)
overall survival5 years
Measured: 5 years
event free survival 5 years
Measured: five years
Disease free survival 5 years
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization, Rabin Medical Center
- Responsible party
- Principal investigator, e_dann, Rambam Health Care Campus
- Investigators
- Eldad J Dann, MD, Study chair, RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392314
- Sponsor's protocol ID
- ISRA2432_CTIL
- Status last verified
- May 2014
- First submitted
- 25 Oct 2006
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study.Tailored Therapy for Hodgkin Lymphoma Based on Predefined Risk Factors and Early Interim PET/CT for Response Assessment and Further Therapy Decisions.
- ClinicalTrials.gov ID
- NCT00392314
- Acronym / sponsor ID
- ISRA2432_CTIL
- Conditions
- Hodgkin Lymphoma
- Keywords
- hodgkin lymphoma, PET/CT, Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization, Rabin Medical Center
- Study start
- Oct 2006
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Oct 2006 (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.
Recently published studies demonstrated very high event free survival for patients with a normal interim PET/CT and a high hazard ratio for progression of an interim positive (pathological)study. These findings strongly support the integration of interim PET as a decision point for adjustment of chemotherapy.This study use the minimal therapy considered safe according to the predefined risk factors for patients with interim negative PET. Those with pathologic interim study considered as higher risk patients will have dose escalation of therapy.remission rate ,event free survival and overall survival will be evaluated.
Detailed description
study aim is to tailor the therapy in order to administer the lowest cumulative dose of therapy yet considered safe in order to reduce both early and late therapy related complications.
patients will be divided according to risk factors to sub groups of early favorable, early unfavorable, advanced disease with score less then 3 points or higher then 3 points.
Early Interim PET will be carried out Further therapy will be based on the study results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early favorable | Experimental | Other: PET/CT post 2 cycles of chemotherapypatients with early favorable disease Ia IIA will have a PET/CT following 2 cycles of ABVD |
| Early Unfavorable | Experimental | Other: PET/CT post 2 cycles of chemotherapyPatients with early favorable disease Ia or IIa with risk factors :large mediastinal mass extra nodal disease elevated esr, three or more involved areas, age equal or >50 , lymphocytic depleted or mixed cellularity |
| advanced disease | Experimental | Other: PET/CT post 2 cycles of chemotherapypatients with advanced disease low IPS score 0-2 will start chemotherapy with ABVD for 2 cycles followed by PET/CT further therapy will be given according to PET/CT results |
| advanced disease IPS 3-7 | Experimental | Other: PET/CT post 2 cycles of chemotherapyPatients with advanced disease IPS score 3-7 will start chemotherapy with escalated beacopp. following 2 cycles PET/CT will be carried out and according to results further chemotherapy will be given |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Hodgkin lymphoma patients
- age 18-60 for those with early disease and advanced disease with score less then 3
- age 18-60 years for patients with advanced disease score 3 or higher classical Hodgkin lymphoma
- WBC more then 3500
- platelets more then 100000
Key exclusion criteria (5 listed)
- Positive serology for HIV
- bilirubin more then 2 mg/dl
- creatinin more then 2 mg/dl
- lactating woman or pregnant
- patient older then 60 years with high risk disease of score 3 or more
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 |
|---|---|---|
| PET/CT post 2 cycles of chemotherapyAlso: F18 deoxyglucose scintigraphysintigraphy with PET/CT following 2 cycles of chemotherapy on day 12-14 following chemotherapy | Other | Early Unfavorable, Early favorable, advanced disease, advanced disease IPS 3-7 |
Primary outcome
Event Free survival in various risk groups of patients
Time frame: five years
Event Free Survival
Time frame: 5 years
3 secondary outcomes
overall survival5 years
Time frame: 5 years
event free survival 5 years
Time frame: five years
Disease free survival 5 years
Time frame: five years
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 9 May 2014.
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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.
Eldad J Dann, MD study chair
RABMAM medical center ,Haifa Israel , Rappapport school of medicine Technion Israel technical Institute Haifa Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET/CT post 2 cycles of chemotherapy in people with Hodgkin Lymphoma, run by Rambam Health Care Campus at 1 site in Israel.
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 8 inclusion and 5 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 9 May 2014. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Event Free survival in various risk groups of patients (time frame: five years). The study lists 2 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 9 May 2014.