B-NHL 2013 - Treatment protocol of the NHL-BFM and the NOPHO study groups for mature aggressive B-cell lymphoma and leukemia in children and adolescents

Conditions

mature aggressive B-cell lymphoma and leukemia in children and adolescents

Brief summary

For R1/R2- patients with stage I+II the primary endpoint is event-free survival (EFS_T) defined as time from start of treatment up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies., For R2 patients with stage III disease (the 1st randomized study question) the primary endpoint is event-free survival (EFS_R) defined as time from randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies., R3/R4 patients(pts)(2nd randomized question): 1.Event-free survival(EFS_T/EFS_R):time from start of treatment(SoT)/randomization up to event or to date of last contact(pts without event).Definition event: non-response,progressive disease or relapse,treatment related death,death of any other cause or diagnosis of secondary malignancies. 2.Immune reconstitution rate: percentage of pts achieving age adjusted normal B-cell counts(CD19+ subpopulations,normal age adjusted range) 12 months after SoT.

Related papers

No related papers found yet.

Interventions

DRUGCYTARABINE

DRUGVINCRISTINE

DRUGIFOSFAMIDE

DRUGPREDNISOLONE

DRUGMETHOTREXATE

DRUGVINDESINE

DRUGETOPOSIDE

DRUGDEXAMETHASONE

DRUGCYCLOPHOSPHAMIDE

DRUGRITUXIMAB

DRUGDOXORUBICIN

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
For R1/R2- patients with stage I+II the primary endpoint is event-free survival (EFS_T) defined as time from start of treatment up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies., For R2 patients with stage III disease (the 1st randomized study question) the primary endpoint is event-free survival (EFS_R) defined as time from randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies., R3/R4 patients(pts)(2nd randomized question): 1.Event-free survival(EFS_T/EFS_R):time from start of treatment(SoT)/randomization up to event or to date of last contact(pts without event).Definition ev	—

Measure

Time frame

For R1/R2- patients with stage I+II the primary endpoint is event-free survival (EFS_T) defined as time from start of treatment up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies., For R2 patients with stage III disease (the 1st randomized study question) the primary endpoint is event-free survival (EFS_R) defined as time from randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies., R3/R4 patients(pts)(2nd randomized question): 1.Event-free survival(EFS_T/EFS_R):time from start of treatment(SoT)/randomization up to event or to date of last contact(pts without event).Definition ev

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Countries

Austria, Czechia, Denmark, Finland, Germany, Norway, Sweden

Outcome results

None listed