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

German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199004

Enrollment

Registered

2005-09-20

Start date

2004-04-30

Completion date

2009-03-31

Last updated

2010-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Acute Lymphocytic Leukemia

Keywords

ALL, Treatment, De novo, Minimal residual disease, Rituximab, Adult

Brief 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

Interventions

DRUGCyclophosphamide

DRUGDexamethasone / Prednisolone

DRUGVincristine

DRUGDaunorubicin

DRUGAsparaginase

DRUGMethotrexate

DRUGCytarabine

DRUGMercaptopurine

DRUGG-CSF

DRUGVindesine

DRUGVP16

DRUGAdriamycin

DRUGThioguanine

DRUGVM26

DRUGRituximab

PROCEDURECNS irradiation

PROCEDUREMediastinal irradiation (if residual TU)

PROCEDUREStem cell transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026