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

Phase 4CompletedNCT00199004

Johann Wolfgang Goethe University Hospital60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adult Acute Lymphocytic Leukemia

Interventions

CyclophosphamideDRUG

Dexamethasone / PrednisoloneDRUG

VincristineDRUG

DaunorubicinDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Frankfurt, Medical Dept. II

Frankfurt, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD

Data from ClinicalTrials.gov

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