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OpenTrials
Completed

NCT Number: NCT00199004

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

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

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Key information

Conditions

Adult Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Frankfurt, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Dexamethasone / Prednisolone

Drug

Vincristine

Drug

Daunorubicin

Drug

asparaginase

Drug

methotrexate

Drug

Cytarabine

Drug

mercaptopurine

Drug

G-CSF

Drug

Vindesine

Drug

VP16

Drug

Adriamycin

Drug

thioguanine

Drug

VM26

Drug

Rituximab

Drug

CNS irradiation

Procedure

Mediastinal irradiation (if residual TU)

Procedure

stem cell transplantation

Procedure

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Aug 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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