Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00433459 |
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Recruitment Status :
Completed
First Posted : February 12, 2007
Last Update Posted : March 26, 2020
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | February 8, 2007 | |||||||||
| First Posted Date ICMJE | February 12, 2007 | |||||||||
| Last Update Posted Date | March 26, 2020 | |||||||||
| Study Start Date ICMJE | January 2007 | |||||||||
| Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Event-free survival [ Time Frame: 5 years ] | |||||||||
| Original Primary Outcome Measures ICMJE |
Event-free survival | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma | |||||||||
| Official Title ICMJE | First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents | |||||||||
| 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: This is a randomized, controlled, parallel-group, open-label, multicenter study. Patients are stratified according to staging and response assessment (central vs local) and disease stage (IA/B or IIA [first-line treatment group 1] vs I_EA/B, II_EA, IIB, or IIIA [first-line treatment group 2] vs II_EB, III_E A/B, IIIB, or IVA/B [first-line treatment group 3]).
Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Patients are assessed by fludeoxyglucose F 18 positron emission tomography (^18FDG-PET) scan. Patients with inadequate response undergo radiotherapy within 35 days after completion of OEPA.
In both arms, treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Patients are assessed by ^18FDG-PET scan. Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC.
Patients with biopsy-confirmed disease progression OR relapse after first-line treatment on this study or on protocols DAL-HD 90, GPOH-HD 95, GPOHHD 2002 Pilot, or similar treatment proceed to second-line therapy. Patients are stratified according to relapse/progression status (late relapse from first-line treatment group 1 [second-line treatment group 1] vs early relapse from first-line treatment groups 1, 2, or 3 or late relapse from first-line treatment groups 2 or 3 [second-line treatment group 2] vs disease progression [second-line treatment group 3]). Patients undergo a ^18FDG-PET scan prior to beginning second-line therapy.
After chemotherapy treatment, patients undergo radiotherapy.
After chemotherapy, patients with an adequate response undergo radiotherapy. Patients with an inadequate response undergo high-dose chemotherapy comprising carmustine IV over 1-2 hours on day -7, etoposide IV and cytarabine IV over 30 minutes twice daily on days -6 to -3, and melphalan IV over 1½ hours on day -2. Patients then undergo autologous hematopoietic stem cell transplantation (HSCT). Patients undergo a ^18FDG-PET scan on day 50-54. Patients with ^18FDG-PET scan positive disease undergo radiotherapy.
Patients undergo a ^18FDG-PET scan on day 50-54. Patients with ^18FDG-PET scan positive disease undergo radiotherapy. After completion of study therapy, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 2,150 patients will be accrued for this study. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Lymphoma | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | 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. Erratum In: Lancet Oncol. 2022 Feb;23(2):e59. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
2134 | |||||||||
| Original Enrollment ICMJE |
2150 | |||||||||
| Actual Study Completion Date ICMJE | January 2013 | |||||||||
| Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 17 Years (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Germany, United Kingdom | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00433459 | |||||||||
| Other Study ID Numbers ICMJE | CDR0000531687 EURONET-PHL-C1 EU-20703 EUDRACT-2006-000995-33 CCLG-HD-2007-10 |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg | |||||||||
| Original Responsible Party | Not Provided | |||||||||
| Current Study Sponsor ICMJE | Christine Mauz-Körholz | |||||||||
| Original Study Sponsor ICMJE | Martin Luther Universitaet | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Martin-Luther-Universität Halle-Wittenberg | |||||||||
| Verification Date | March 2020 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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