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

• Status: Active, not recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christine Mauz-Körholz
• Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany); Euronet Worldwide
• Treatments: Cyclophosphamide; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Vinblastine

Criteria

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)