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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)


Phase 4
15 Years
65 Years
Not Enrolling
Both
Adult Acute Lymphocytic Leukemia

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Dieter Hoelzer, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital, Medical Dept. II

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GMALL03

NCT ID:

NCT00199004

Start Date:

April 2004

Completion Date:

March 2009

Related Keywords:

  • Adult Acute Lymphocytic Leukemia
  • ALL
  • Treatment
  • De novo
  • Minimal residual disease
  • Rituximab
  • Adult
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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