Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
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| ClinicalTrials.gov Identifier: NCT01516567 |
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Recruitment Status :
Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : August 2, 2017
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Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
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Brief Summary:
Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Mediastinal Large B Cell Lymphoma | Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 47 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL |
| Actual Study Start Date : | December 1, 2011 |
| Actual Primary Completion Date : | April 2016 |
| Estimated Study Completion Date : | April 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
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Experimental: DA-EPOCH-R
6 courses of Dose Adjusted-EPOCH-Rituximab
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Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab
6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH. |
Primary Outcome Measures :
- Event free survival [ Time Frame: 36 months ]Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.
Secondary Outcome Measures :
- Survival [ Time Frame: 5 years ]Overall survival
- Acute toxicity [ Time Frame: 6 months ]Acute toxicity during treatment according to NCI-CTC V4
- Long term toxicity [ Time Frame: 5 years ]Long term toxicity, especially immune reconstitution, cardiac toxicity
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| Ages Eligible for Study: | 6 Months to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL).
- PMLBL without central nervous system (CNS) involvement.
- 6 months to less than 18 years of age at the time of consent.
- Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab
- Complete initial work-up within 8 days prior to treatment that allows definite staging.
- Able to comply with scheduled follow-up and with management of toxicity.
- Signed informed consent from patients and/or their parents or legal guardians
Exclusion Criteria:
- Follicular lymphoma, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone
- PMLBL patients with CNS involvement
- Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
- Evidence of pregnancy or lactation period.
- There will be no exclusion criteria based on organ function.
- Past or current anti-cancer treatment except corticosteroids during less than one week.
- Tumor cell negative for CD20
- Prior exposure to rituximab.
- Severe active viral infection, especially hepatitis B.
- Hepatitis B carrier status history of hepatitis B virus (HBV) or positive serology.
- Participation in another investigational drug clinical trial.
- Patients who, for any reason, are not able to comply with the national legislation.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516567
Locations
| Belgium | |
| University Hospitals Leuven | |
| Leuven, Belgium, 3000 | |
| Canada | |
| Children Oncology Group Operations centres | |
| Monrovia, Canada | |
| France | |
| Gustave Roussy | |
| Villejuif, France, 94805 | |
| Hungary | |
| 2nd Dept. of Pediatrics Semmelweis Univ. | |
| Budapest, Hungary, 1094 | |
| Italy | |
| Associazione Italiana di Ematologia ed Oncologia Pediatrica | |
| Padova, Italy, 35128 | |
| Netherlands | |
| Emma Children's Hospital | |
| Amsterdam, Netherlands, 1105 AZ | |
| Poland | |
| Rectorat of Medical University | |
| Wroclaw, Poland | |
| Spain | |
| Sociedad Española de Hematología y Oncología Pediátricas | |
| Valencia, Spain, 46010 | |
| United Kingdom | |
| University of Birmingham | |
| Birmingham, United Kingdom | |
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Children's Oncology Group
Investigators
| Study Chair: | Catherine PATTE, MD | Institut Gustave Roussy, Villejuif, FRANCE | |
| Study Chair: | Thomas GROSS, MD | Children's Oncology Group, USA |
Additional Information:
| Responsible Party: | Gustave Roussy, Cancer Campus, Grand Paris |
| ClinicalTrials.gov Identifier: | NCT01516567 History of Changes |
| Obsolete Identifiers: | NCT01595048 |
| Other Study ID Numbers: |
Inter B-NHL Ritux 2010 Phase 2 2010-019224-31 ( EudraCT Number ) |
| First Posted: | January 25, 2012 Key Record Dates |
| Last Update Posted: | August 2, 2017 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Doxorubicin Etoposide Vincristine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents |