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

NCT01088750 | Completed Phase 4 DMC

• 2 other identifiers: CDR00006673692007-004092-19
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Time from treatment start until relapse/progression, secondary malignancy or death

  5 years

Secondary Outcomes (4)

• Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II

  5 years

• Overall survival

  5 years

• Common Toxicity criteria toxicity Levels of therapy elements

  5 years

• Complications of surgery

  5 years

Study Arms (2)

surgery alone

OTHER

watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL

Other: watchful waiting; Procedure: therapeutic conventional surgery

CVP Chemotherapy

EXPERIMENTAL

3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)

Drug: cyclophosphamide; Drug: prednisolone; Drug: vinblastine sulfate

Interventions

cyclophosphamide DRUG

Also known as: CYC

CVP Chemotherapy

prednisolone DRUG

Also known as: PRED

CVP Chemotherapy

vinblastine sulfate DRUG

Also known as: VBL

CVP Chemotherapy

watchful waiting OTHER

surgery alone

therapeutic conventional surgery PROCEDURE

surgery alone

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Christine Mauz-Körholz: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator
• Euronet Worldwide: collaborator

Study Sites (1)

Universitaetsklinikum Giessen-Marburg

Giessen, D-35385, Germany

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Cyclophosphamide; Prednisolone; prednylidene; Vinblastine; Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Dieter Koerholz, MD

  Universitaetsklinikum Giessen und Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Christine Mauz-Körholz

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: November 1, 2009
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

DE (1)