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.
Brief Title
Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation
Completion Date
Completion Date Type
Estimated
Conditions
Primary Mediastinal Large B Cell Lymphoma
Eligibility 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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
6 Months
NCT Id
NCT01516567
Org Class
Other
Org Full Name
Gustave Roussy, Cancer Campus, Grand Paris
Org Study Id
Inter B-NHL Ritux 2010 Phase 2
Overall Status
Unknown status
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Event free survival
Outcome Time Frame
36 months
Secondary Ids
Secondary Id
2010-019224-31
Secondary Outcomes
Outcome Description
Overall survival
Outcome Time Frame
5 years
Outcome Measure
Survival
Outcome Description
Acute toxicity during treatment according to NCI-CTC V4
Outcome Time Frame
6 months
Outcome Measure
Acute toxicity
Outcome Description
Long term toxicity, especially immune reconstitution, cardiac toxicity
Outcome Time Frame
5 years
Outcome Measure
Long term toxicity
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Gill
Investigator Email
jgill@montefiore.org
Investigator Phone
718-741-2331
MeSH Terms
ETOPOSIDE
DOXORUBICIN
VINCRISTINE
CYCLOPHOSPHAMIDE
RITUXIMAB
PODOPHYLLOTOXIN
TETRAHYDRONAPHTHALENES
NAPHTHALENES
POLYCYCLIC AROMATIC HYDROCARBONS
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
ORGANIC CHEMICALS
POLYCYCLIC COMPOUNDS
GLUCOSIDES
GLYCOSIDES
CARBOHYDRATES
DAUNORUBICIN
ANTHRACYCLINES
NAPHTHACENES
AMINOGLYCOSIDES
VINCA ALKALOIDS
SECOLOGANIN TRYPTAMINE ALKALOIDS
INDOLE ALKALOIDS
ALKALOIDS
HETEROCYCLIC COMPOUNDS
INDOLES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
INDOLIZIDINES
INDOLIZINES
PHOSPHORAMIDE MUSTARDS
NITROGEN MUSTARD COMPOUNDS
MUSTARD COMPOUNDS
HYDROCARBONS, HALOGENATED
PHOSPHORAMIDES
ORGANOPHOSPHORUS COMPOUNDS
ANTIBODIES, MONOCLONAL, MURINE-DERIVED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS