CompletedNCT01088750EuroNetLP1Updated Dec 13, 2023

Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma

A Phase 4 interventional study of cyclophosphamide and prednisolone in Lymphoma, sponsored by Christine Mauz-Körholz. Completed at 1 site in Germany. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Christine Mauz-Körholz · Phase 4, Interventional, and Treatment

From the registry’s dates

Registered 4 months after the study started (first participant enrolled Nov 2009, registered Mar 2010).

Phase: Phase 4
Study type: Interventional
Enrollment: 225
Allocation: Non-randomized
Ages: Up to 17 Years
Sex: All

Study 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. 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 studied

Lymphoma

Browse trials for

Keywords

childhood nodular lymphocyte predominant Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 225 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Christine Mauz-Körholz is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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
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)

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 225 participants (actual)

Study arms

Other
surgery alone
watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL
Other: watchful waiting · Procedure: therapeutic conventional surgery
Experimental
CVP Chemotherapy
3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
Drug: cyclophosphamide · Drug: prednisolone · Drug: vinblastine sulfate

Interventions

Drugcyclophosphamide
Also known as: CYC
Drugprednisolone
Also known as: PRED
Drugvinblastine sulfate
Also known as: VBL
Otherwatchful waiting
Proceduretherapeutic conventional surgery

What researchers measure

Primary outcomes

Event-free survival
Time from treatment start until relapse/progression, secondary malignancy or death
Time frame: 5 years

Secondary outcomes

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
Time frame: 5 years
Overall survival
Time from treatment start until death
Time frame: 5 years
Common Toxicity criteria toxicity Levels of therapy elements
Evaluation of AEs, SAEs atc. according to CTC
Time frame: 5 years
Complications of surgery
Listing of surgical complications
Time frame: 5 years

Study locations

1 site

Universitaetsklinikum Giessen-Marburg
Giessen, D-35385, Germany

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01088750
Lead sponsor: Christine Mauz-Körholz
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide
Responsible party: Christine Mauz-Körholz (Prof. Dr. Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg) — Sponsor-investigator
First posted: Mar 17, 2010
Start date: Nov 1, 2009
Primary completion: Oct 31, 2023
Completion: Oct 31, 2023
Last update: Dec 13, 2023

Study contacts

Dieter Koerholz, MD

principal investigator · Universitaetsklinikum Giessen und Marburg

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma→

Other studies from this sponsor

Christine Mauz-Körholz

Start the discussion