Classical Hodgkin LymphomaNCT00305149
Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma
A study testing interim therapy scintigraphy study gallium scan or PET/CT and "interim gallium or PET/CT" in people with Classical Hodgkin Lymphoma and Nodular Sclerosis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
.This study is trying to address change of chemotherapy dosage according to individual patient response to initial cycles of chemotherapy in order to reduce cumulative dose of chemotherapy.The study includes patients with early unfavorable and advanced hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Classical Hodgkin Lymphoma, Nodular Sclerosis, Mixed Cellularity
- What is being tested?
- interim therapy scintigraphy study gallium scan or PET/CT and "interim gallium or PET/CT"
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 1999to Dec 2005
- Phase
- Interventional
- 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
- stage I-IIA/B with adverse prognostic or III-IV disease
- Age 18 and Over
- Performance status ECOG 0-3
- Hematopoietic WBC at least 4000/mm3(unless documented bone marrow involvement)
- Hepatic bilirubin no greater then 5 mg/dL
- RENAL:Creatinine no greater than 2.0mg/dL
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- not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No other malignancy within the past 5 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Risk Factors for Initiation Therapy With Beacopp or Escalated Beacopp and Interim Evaluation and Modification of Therapy Based on Scintigraphy Results.
.This study is trying to address change of chemotherapy dosage according to individual patient response to initial cycles of chemotherapy in order to reduce cumulative dose of chemotherapy.The study includes patients with early unfavorable and advanced hodgkin lymphoma. Patients with low risk were started with standard beacopp and only high risk patients were started with escalated beacopp.Following 2 cycles of therapy the patients were reassessed.Based on scintigraphy results decision was made regarding further therapylative chemotherapy for early responders and maximize dose intensity for late responders.
Read the detailed description
Patients were eligible if they had early unfavorable disease or patients who presented with stage III or IV disease .Pt assigned to receive 6 cycles of Bleomycin Etoposide, Doxorubicin, Cyclophosphamide Procarbazine, Prednisone (BEACOPP) or increased dose BEACOPP. (IDB). Patient with Stage I or II with ³4 sites of disease, age ³50, ESR³50 "B" symptoms lymphocyte depleted histology "E" site, or bulky disease were defined as early unfavorable disease and were given standard BEACOPP (SB). Those with I, II B or bulky disease or Stage III, IV were defined according the IPS. Increased dose BEACOPP (IDB) cycles of therapy was initiated only to patients with IPS of 3 or more risk factors (high risk) Standard BEACOPP (SB) cycles were initiated to those with a score of 0-2 (standard risk). All patients had baseline GA67 or hybrid PET\CT scan at diagnosis and post first cycle for gallium scan or second cycle for hybrid PET\CT. Upon the scan results therapy was planned and given for addition of 4 cycles. Those with negative scan received cycles of SB as of the third cycle. Dose was reduced to level I to III if patient was hospitalized due to fever and neutropenia of 5 days or longer or pt had an episode of sepsis with unstable vital signs.
Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a total of 6 cycles
- Conditions
- Classical Hodgkin Lymphoma, Nodular Sclerosis, Mixed Cellularity, Lymphocyte Depletion, Lymphocyte Rich
- Being tested
- interim therapy scintigraphy study gallium scan or PET/CT, "interim gallium or PET/CT"
- Keywords
- Hodgkin Lymphoma, BEACOPP, PET, Gallium, Tailored 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.
interim therapy scintigraphy study gallium scan or PET/CTProcedure or surgery
"interim gallium or PET/CT"Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startJul 1999
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ron Epelbaum, ND, Study director, Rambam health care center, Bruce Rappaport Faculty of Medicine Technion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305149
- Sponsor's protocol ID
- riskadapted beacopp/CTIL
- Status last verified
- Mar 2006
- First submitted
- 20 Mar 2006
- Last updated
- 21 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Risk Factors for Initiation Therapy With Beacopp or Escalated Beacopp and Interim Evaluation and Modification of Therapy Based on Scintigraphy Results.
- ClinicalTrials.gov ID
- NCT00305149
- Acronym / sponsor ID
- riskadapted beacopp/CTIL
- Conditions
- Classical Hodgkin Lymphoma, Nodular Sclerosis, Mixed Cellularity, Lymphocyte Depletion, Lymphocyte Rich
- Keywords
- Hodgkin Lymphoma, BEACOPP, PET, Gallium, Tailored therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 1999
- Study completion
- Dec 2005
- First posted
- 21 Mar 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.
.This study is trying to address change of chemotherapy dosage according to individual patient response to initial cycles of chemotherapy in order to reduce cumulative dose of chemotherapy.The study includes patients with early unfavorable and advanced hodgkin lymphoma. Patients with low risk were started with standard beacopp and only high risk patients were started with escalated beacopp.Following 2 cycles of therapy the patients were reassessed.Based on scintigraphy results decision was made regarding further therapylative chemotherapy for early responders and maximize dose intensity for late responders.
Detailed description
Patients were eligible if they had early unfavorable disease or patients who presented with stage III or IV disease .Pt assigned to receive 6 cycles of Bleomycin Etoposide, Doxorubicin, Cyclophosphamide Procarbazine, Prednisone (BEACOPP) or increased dose BEACOPP. (IDB). Patient with Stage I or II with ³4 sites of disease, age ³50, ESR³50 "B" symptoms lymphocyte depleted histology "E" site, or bulky disease were defined as early unfavorable disease and were given standard BEACOPP (SB). Those with I, II B or bulky disease or Stage III, IV were defined according the IPS. Increased dose BEACOPP (IDB) cycles of therapy was initiated only to patients with IPS of 3 or more risk factors (high risk) Standard BEACOPP (SB) cycles were initiated to those with a score of 0-2 (standard risk). All patients had baseline GA67 or hybrid PET\CT scan at diagnosis and post first cycle for gallium scan or second cycle for hybrid PET\CT. Upon the scan results therapy was planned and given for addition of 4 cycles. Those with negative scan received cycles of SB as of the third cycle. Dose was reduced to level I to III if patient was hospitalized due to fever and neutropenia of 5 days or longer or pt had an episode of sepsis with unstable vital signs.
Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a total of 6 cycles
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- stage I-IIA/B with adverse prognostic or III-IV disease
- Age 18 and Over
- Performance status ECOG 0-3
- Hematopoietic WBC at least 4000/mm3(unless documented bone marrow involvement)
- Hepatic bilirubin no greater then 5 mg/dL
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| interim therapy scintigraphy study gallium scan or PET/CT | Procedure or surgery | – |
| "interim gallium or PET/CT" | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 21 Mar 2006.
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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.
Ron Epelbaum, ND study director
Rambam health care center, Bruce Rappaport Faculty of Medicine Technion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interim therapy scintigraphy study gallium scan or PET/CT and "interim gallium or PET/CT" in people with Classical Hodgkin Lymphoma and Nodular Sclerosis, 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 10 inclusion and 1 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 21 Mar 2006. 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.
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.
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 21 Mar 2006.