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

J

Johann Wolfgang Goethe University Hospital

Status and phase

Completed
Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Treatments

Drug: Rituximab
Drug: Asparaginase
Procedure: Mediastinal irradiation (if residual TU)
Procedure: Stem cell transplantation
Drug: Mercaptopurine
Drug: Dexamethasone / Prednisolone
Drug: Vindesine
Drug: Cyclophosphamide
Procedure: CNS irradiation
Drug: Adriamycin
Drug: Daunorubicin
Drug: Methotrexate
Drug: VM26
Drug: Thioguanine
Drug: G-CSF
Drug: Vincristine
Drug: Cytarabine
Drug: VP16

Study type

Interventional

Funder types

Other

Identifiers

NCT00199004
GMALL03

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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