LymphomaPhase 4EuroNetLP1NCT01088750
Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
A Phase 4 study testing cyclophosphamide, prednisolone and vinblastine sulfate in people with Lymphoma, run by Christine Mauz-Körholz at 1 site in Germany.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- cyclophosphamide, prednisolone and vinblastine sulfate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2009to 31 Oct 2023
- Phase
- Phase 4
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.
- initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone
- patient aged under 18 years at time of diagnosis
- written informed consent of the patient and/or the patient's parents or guardian according to national laws
Who cannot join
- pre-treatment of Hodgkin's lymphoma differing from study protocol
- Any extra-nodal involvement
- Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment
- known hypersensitivity or contraindication to study drugs
- prior chemotherapy or radiotherapy
- Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids
Show all 12Show fewer
- Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial
- other (simultaneous) malignancies
- severe concomitant diseases (e.g. immune deficiency syndrome)
- known HIV positivity
- pregnancy and / or lactation
- females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.
PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone.
Secondary
- Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients.
OUTLINE:
- Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment.
- Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol.
After completion of study treatment, patients are followed-up periodically.
- Conditions
- Lymphoma
- Being tested
- cyclophosphamide, prednisolone, vinblastine sulfate, watchful waiting, therapeutic conventional surgery
- Keywords
- childhood nodular lymphocyte predominant Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Also called CYC
prednisoloneDrug
Also called PRED
vinblastine sulfateDrug
Also called VBL
watchful waitingOther
therapeutic conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery alone | Other | watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL Receives: Other: watchful waiting; Procedure: therapeutic conventional surgery |
| CVP Chemotherapy | Experimental | 3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone) Receives: Drug: cyclophosphamide; Drug: prednisolone; Drug: vinblastine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Time from treatment start until relapse/progression, secondary malignancy or death
Measured: 5 years
Secondary outcomes (4)
Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II
Stage greater than IIA at relapse diagnosis
Measured: 5 years
Overall survival
Time from treatment start until death
Measured: 5 years
Common Toxicity criteria toxicity Levels of therapy elements
Evaluation of AEs, SAEs atc. according to CTC
Measured: 5 years
Complications of surgery
Listing of surgical complications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study start1 Nov 2009
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Mauz-Körholz
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide
- Responsible party
- Sponsor-investigator, Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Dieter Koerholz, MD, Principal investigator, Universitaetsklinikum Giessen und Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088750
- Sponsor's protocol ID
- CDR0000667369
- Other IDs
- 2007-004092-19
- Acronym
- EuroNetLP1
- Status last verified
- Dec 2023
- First submitted
- 16 Mar 2010
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01088750
- Acronym / sponsor ID
- EuroNetLP1 / CDR0000667369
- Conditions
- Lymphoma
- Keywords
- childhood nodular lymphocyte predominant Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Christine Mauz-KörholzUniversity, hospital or other
- Collaborators
- Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 17 Mar 2010 (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.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.
PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone.
Secondary
- Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients.
OUTLINE:
- Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment.
- Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol.
After completion of study treatment, patients are followed-up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery alone | Other | Other: watchful waiting, Procedure: therapeutic conventional surgerywatch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL |
| CVP Chemotherapy | Experimental | Drug: cyclophosphamide, Drug: prednisolone, Drug: vinblastine sulfate3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone) |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.
- initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone
- patient aged under 18 years at time of diagnosis
- written informed consent of the patient and/or the patient's parents or guardian according to national laws
Key exclusion criteria (12 listed)
- pre-treatment of Hodgkin's lymphoma differing from study protocol
- Any extra-nodal involvement
- Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment
- known hypersensitivity or contraindication to study drugs
- prior chemotherapy or radiotherapy
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 |
|---|---|---|
| cyclophosphamideAlso: CYC | Drug | CVP Chemotherapy |
| prednisoloneAlso: PRED | Drug | CVP Chemotherapy |
| vinblastine sulfateAlso: VBL | Drug | CVP Chemotherapy |
| watchful waiting | Other | surgery alone |
| therapeutic conventional surgery | Procedure or surgery | surgery alone |
Primary outcome
Event-free survival
Time frame: 5 years
Time from treatment start until relapse/progression, secondary malignancy or death
4 secondary outcomes
Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II
Time frame: 5 years
Overall survival
Time frame: 5 years
Common Toxicity criteria toxicity Levels of therapy elements
Time frame: 5 years
Complications of surgery
Time frame: 5 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 13 Dec 2023.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Dieter Koerholz, MD principal investigator
Universitaetsklinikum Giessen und Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cyclophosphamide, prednisolone and vinblastine sulfate in people with Lymphoma, run by Christine Mauz-Körholz at 1 site in Germany.
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 12 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 13 Dec 2023. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: 5 years). 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 13 Dec 2023.