CompletedPhase 4

Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

Germany60 participantsStarted 2004-04

Plain-language summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

Who can participate

Age range15 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * B-precursor ALL (common / pre B-ALL) * Standard risk * CD20 expression \>20% * Ph/BCR-ABL negative * Age 15-65 years (55-65 if biologically younger) * Written informed consent Exclusion Criteria: * Severe complications due to leukemia or secondary illnesses * Late relapse of childhood ALL * Cytostatic pretreatment * Pregnancy * Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent * Known severe allergy to foreign proteins

What they're measuring

Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival

Trial details

NCT IDNCT00199004

SponsorJohann Wolfgang Goethe University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

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