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Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial


Phase 3
6 Months
18 Years
Open (Enrolling)
Both
B-cell Non Hodgkin Lymphoma, Mature B-cell Leukemia Burkitt-type

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Trial Information

Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial


Inclusion Criteria:



- Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma
or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature
B-cell NHL non other specified or specifiable.

- Stage III with elevated LDH level ("B-high"), [LDH > twice the institutional upper
limit of the adult normal values (> Nx2)] or any stage IV or B-AL.

- 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 and
during five months for men, taking into account the characteristics of methotrexate.

- 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, MALT and nodular marginal zone are not included into this
therapeutic study

- 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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival

Outcome Description:

Minimum time to death from any cause, presence of viable cells in residue after [2nd (Rituximab-)CYVE], relapse, progressive disease, or second malignancy measured from randomization.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Catherine PATTE, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Gustave Roussy, Villejuif, FRANCE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Inter B-NHL Ritux 2010 Phase 3

NCT ID:

NCT01516580

Start Date:

December 2011

Completion Date:

December 2021

Related Keywords:

  • B-cell Non Hodgkin Lymphoma
  • Mature B-cell Leukemia Burkitt-type
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, B-Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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