HODLP: First International Inter-Group Study for Nodular Lymphocyte Predominant Hodgkin Lymphoma in Children and Adolescents

Surgery Alone, Surgery With Cyclophosphamide, Vinblastine, and Prednisolone (CVP), or CVP Alone in Treating Young Patients With Stage IA or Stage IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Categories:

Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Lymphocyte predominant Hodgkin lymphoma 

Eligibility Overview:

  • Diagnosis of early-stage lymphocyte-predominant Hodgkin lymphoma (LPHL)
  • LPHL that has not been previously treated with chemotherapy or radiation therapy
  • 18 years of age or younger

 

  1. Brief Summary

    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.

    This phase 4 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.

    Primary Objective

    To 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.

    Trial 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

    Interventions

    • Drugs: Cyclophosphamide, prednisolone, vinblastine sulfate
    • Other: Watchful waiting
    • Procedure: Therapeutic conventional surgery

    Eligibility Criteria

    Inclusion Criteria:

    Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (stage IA or IIA disease)

    Exclusion Criteria:

    Prior therapy

    Study Design

    • Masking: Open Label
    • Primary Purpose: Treatment
  2. About this clinical trial

    HODLP is a Phase II clinical trial for a rare form of Hodgkin lymphoma known as Lymphocyte Predominant Hodgkin Lymphoma (LPHL). LPHL, especially in its early stages, is one of the most treatable and curable childhood cancers. The standard treatment for early-stage LPHL involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to kill cancer cells).

    Most patients can be cured from LPHL. Some may experience serious side effects from treatment later in life. This can include problems with:

    • Growth
    • Fertility
    • Some organ functions
    • Development of another kind of cancer (called secondary cancer)

    Better treatments with fewer long-term side effects are needed, which is why St. Jude is offering this clinical trial. It is thought that if patients with early-stage LPHL can be successfully treated with less intense therapy, they may have fewer serious side effects later in life.

    Purpose of this clinical trial

    The main goal of this study is to find out if treatment for childhood LPHL can be further improved with less treatment and reduce the long-term side effects from therapy, while keeping the same or improving the response and survival rates previously seen with standard therapy.

    Treatment

    The type of treatment your child will receive will depend on the stage (where the lymphoma is located and how much it has spread) . Previous studies have shown that some patients with early-stage LPHL can be cured by having all of their disease removed with surgery only. Therefore, participants in this study may receive surgery alone or lower-doses of chemotherapy.

    Eligibility overview

    • Diagnosis of early-stage lymphocyte-predominant Hodgkin lymphoma (LPHL)
    • LPHL that has not been previously treated with chemotherapy or radiation therapy
    • 18 years of age or younger
  3. HODLP  Quick View

    Sponsor

    Martin-Luther-Universität Halle-Wittenberg

    ClinicalTrials.gov identifier

    NCT01088750

    Trial start date

    November 2009

    Estimated enrollment

    200

    Study type

    Interventional

    Study phase

    Phase 2

    Condition

    Lymphoma

    Ages

    Up to 17 years

    Principal investigator

    Monika Metzger, MD, MSc

    Study sites

    Universitaetsklinikum Halle (Germany) and St. Jude Children’s Research Hospital

    For a consultation or to discuss HODLP

    St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Monika Metzger, MD, MSc

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.