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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199004
First received: September 12, 2005
Last updated: August 20, 2010
Last verified: May 2008
  Purpose

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


Condition Intervention Phase
Adult Acute Lymphocytic Leukemia
Drug: 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
Procedure: CNS irradiation
Procedure: Mediastinal irradiation (if residual TU)
Procedure: Stem cell transplantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival

Secondary Outcome Measures:
  • Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD

Estimated Enrollment: 60
Study Start Date: April 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199004

Locations
Germany
University Hospital of Frankfurt, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Study Chair: Dieter Hoelzer, MD,PhD University Hospital, Medical Dept. II
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199004     History of Changes
Other Study ID Numbers: GMALL03
Study First Received: September 12, 2005
Last Updated: August 20, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
ALL
Treatment
De novo
Minimal residual disease
Rituximab
Adult

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Cyclophosphamide
Daunorubicin
Dexamethasone
Methotrexate
Rituximab
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 29, 2014