Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma

NCT00433459 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000531687EURONET-PHL-C1EU-20703EUDRACT-2006-000995-33CCLG-HD-2007-10
• Study Type: interventional
• Target: 2,134
• Locations: 2 countries
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

childhood lymphocyte depletion Hodgkin lymphoma; childhood mixed cellularity Hodgkin lymphoma; childhood nodular sclerosis Hodgkin lymphoma; stage I childhood Hodgkin lymphoma; stage II childhood Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage IV childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  5 years

Secondary Outcomes (6)

• Overall survival

  5 years

• Progression-free survival

  5 years

• CTC (Common toxicity criteria) toxicity levels of therapy elements

  5 years

• Evidence of male infertility score

  5 years

• Evidence of female infertility score

  5 years

Study Arms (2)

COPP

ACTIVE COMPARATOR

procarbazine-containing consolidation chemotherapy arm

Drug: cyclophosphamide; Drug: prednisolone; Drug: prednisone; Drug: procarbazine hydrochloride; Drug: vincristine sulfate; Radiation: fludeoxyglucose F 18; Radiation: radiation therapy

COPDAC

EXPERIMENTAL

procarbazine-free consolidation chemotherapy arm

Drug: cyclophosphamide; Drug: dacarbazine; Drug: prednisolone; Drug: prednisone; Drug: vincristine sulfate; Radiation: fludeoxyglucose F 18; Radiation: radiation therapy

Interventions

cyclophosphamide DRUG

drug is used in first line treatment in combination (COPP or COPDAC)

Also known as: CYC

COPDAC; COPP

dacarbazine DRUG

drug is used in first line treatment in combination (COPDAC)

Also known as: DTIC

COPDAC

prednisolone DRUG

drug is used in first line treatment in combination (OEPA, COPP or COPDAC)

COPDAC; COPP

prednisone DRUG

drug is used in first line treatment in combination (OEPA, COPP or COPDAC)

COPDAC; COPP

procarbazine hydrochloride DRUG

drug is used in first line treatment in combination (COPP)

COPP

vincristine sulfate DRUG

drug is used in first line treatment in combination (OEPA, COPP or COPDAC)

Also known as: VCR

COPDAC; COPP

fludeoxyglucose F 18 RADIATION

used as a diagnostic marker for metabolically active tumour at staging and response assessment

COPDAC; COPP

radiation therapy RADIATION

part of combination treatment (combined modality between chemo- and radiotherapy)

Also known as: IFRT

COPDAC; COPP

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed classical Hodgkin's lymphoma * No lymphocyte-predominant Hodgkin's lymphoma * Fine-needle biopsy not sufficient * No prior treatment for Hodgkin's lymphoma except for recommended pre-phase therapy for a large mediastinal tumor PATIENT CHARACTERISTICS: * No known hypersensitivity or contraindication to study drugs * No other current malignancy * No severe concurrent disease (e.g., immune deficiency syndrome) * Not pregnant or nursing * Fertile patients must use effective contraception during and for up to 1 year after completion of study treatment * No known HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy or radiotherapy * At least 30 days since prior and no other concurrent investigational drugs or participation in another investigational trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (2)

Universitaetsklinikum Giessen-Marburg

Giessen, D-35385, Germany

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Related Publications (5)

• Daw S, Claviez A, Kurch L, Stoevesandt D, Attarbaschi A, Balwierz W, Beishuizen A, Cepelova M, Ceppi F, Fernandez-Teijeiro A, Fossa A, Georgi TW, Hjalgrim LL, Hraskova A, Leblanc T, Mascarin M, Pears J, Landman-Parker J, Prelog T, Klapper W, Ramsay A, Kluge R, Dieckmann K, Pelz T, Vordermark D, Korholz D, Hasenclever D, Mauz-Korholz C. Transplant and Nontransplant Salvage Therapy in Pediatric Relapsed or Refractory Hodgkin Lymphoma: The EuroNet-PHL-R1 Phase 3 Nonrandomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):258-267. doi: 10.1001/jamaoncol.2024.5636.

  PMID: 39745682 DERIVED

• Pabari R, McCarten K, Flerlage J, Lai H, Mauz-Korholz C, Dieckmann K, Palese M, Kaste S, Castellino SM, Kelly KM, Stoevesandt D, Kurch L. Hodgkin lymphoma involving the extra-axial CNS: an AHOD1331, PHL-C1, and PHL-C2 report from the COG and EuroNet-PHL. Blood Adv. 2024 Sep 24;8(18):4856-4865. doi: 10.1182/bloodadvances.2023012346.

  PMID: 39058968 DERIVED

• Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.

  PMID: 37505794 DERIVED

• Mauz-Korholz C, Landman-Parker J, Fernandez-Teijeiro A, Attarbaschi A, Balwierz W, Bartelt JM, Beishuizen A, Boudjemaa S, Cepelova M, Ceppi F, Claviez A, Daw S, Dieckmann K, Fossa A, Gattenlohner S, Georgi T, Hjalgrim LL, Hraskova A, Karlen J, Kurch L, Leblanc T, Mann G, Montravers F, Pears J, Pelz T, Rajic V, Ramsay AD, Stoevesandt D, Uyttebroeck A, Vordermark D, Korholz D, Hasenclever D, Wallace WH, Kluge R. Response-adapted omission of radiotherapy in children and adolescents with early-stage classical Hodgkin lymphoma and an adequate response to vincristine, etoposide, prednisone, and doxorubicin (EuroNet-PHL-C1): a titration study. Lancet Oncol. 2023 Mar;24(3):252-261. doi: 10.1016/S1470-2045(23)00019-0.

  PMID: 36858722 DERIVED

• Mauz-Korholz C, Landman-Parker J, Balwierz W, Ammann RA, Anderson RA, Attarbaschi A, Bartelt JM, Beishuizen A, Boudjemaa S, Cepelova M, Claviez A, Daw S, Dieckmann K, Fernandez-Teijeiro A, Fossa A, Gattenlohner S, Georgi T, Hjalgrim LL, Hraskova A, Karlen J, Kluge R, Kurch L, Leblanc T, Mann G, Montravers F, Pears J, Pelz T, Rajic V, Ramsay AD, Stoevesandt D, Uyttebroeck A, Vordermark D, Korholz D, Hasenclever D, Wallace WH. Response-adapted omission of radiotherapy and comparison of consolidation chemotherapy in children and adolescents with intermediate-stage and advanced-stage classical Hodgkin lymphoma (EuroNet-PHL-C1): a titration study with an open-label, embedded, multinational, non-inferiority, randomised controlled trial. Lancet Oncol. 2022 Jan;23(1):125-137. doi: 10.1016/S1470-2045(21)00470-8. Epub 2021 Dec 9.

  PMID: 34895479 DERIVED

Related Links

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

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Cyclophosphamide; Dacarbazine; Prednisolone; Prednisone; Procarbazine; Vincristine; Fluorodeoxyglucose F18; Radiotherapy

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; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxyglucose; Deoxy Sugars; Carbohydrates; Therapeutics

Study Officials

• Dieter Koerholz, MD

  Martin-Luther-Universität Halle-Wittenberg

  STUDY CHAIR

• W. Hamish Wallace, MD

  Royal Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Judith Landman-Parker, MD

  Hopital d'Enfants Trousseau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Christine Mauz-Körholz

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 12, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

DE (1); GB (1)