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

NCT ID: NCT00199004

Last Updated: 2010-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Adult Acute Lymphocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cyclophosphamide

Intervention Type DRUG

Dexamethasone / Prednisolone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Asparaginase

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

G-CSF

Intervention Type DRUG

Vindesine

Intervention Type DRUG

VP16

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Thioguanine

Intervention Type DRUG

VM26

Intervention Type DRUG

Rituximab

Intervention Type DRUG

CNS irradiation

Intervention Type PROCEDURE

Mediastinal irradiation (if residual TU)

Intervention Type PROCEDURE

Stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Dieter Hoelzer, MD,PhD

Role: STUDY_CHAIR

University Hospital, Medical Dept. II

Locations

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University Hospital of Frankfurt, Medical Dept. II

Frankfurt, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.studienregister-online.de

German Leukemia Trial Registry

Other Identifiers

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GMALL03

Identifier Type: -

Identifier Source: org_study_id

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