We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00198978
Recruitment Status : Unknown
Verified June 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date June 5, 2008
Study Start Date  ICMJE January 2003
Estimated Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2006)
Remission rate (cytologic, Remission rate (molecular), Survival time, Duration of Remission, Toxicity (CTC, Treatment realization
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • - Remission rate (cytologic)
  • - Remission rate (molecular)
  • - Survival time
  • - Duration of Remission
  • - Toxicity (CTC)
  • - Treatment realization
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Official Title  ICMJE Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
Brief Summary The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adult Acute Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Cyclophosphamide
  • Drug: Dexamethasone / Prednisolone
  • Drug: Cytarabine
  • Drug: Idarubicin
  • Drug: Granulocyte-Colony-Stimulating Factor
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Rituximab
  • Drug: HDARAC
  • Drug: Vincristine
  • Drug: Depocyte
  • Drug: Asparaginase
Study Arms  ICMJE Not Provided
Publications * Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2008)
200
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
120
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
  • Age > 55 yrs (no upper age limit)
  • Written informed consent

Exclusion Criteria:

  • Severe leukemia associated complications, not controllable before therapy onset e.g.
  • life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
  • Severe comorbidity e.g.
  • decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
  • heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
  • hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin > 1,5 x ULN and/or ASA, ALA, AP > 2,5 ULN
  • decompensated metabolic disturbances (e.g. not controllable diabetes)
  • severe obstructive or restrictive pulmonary disease with hypoxaemia
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Active second neoplasia
  • HIV infection
  • Severely reduced general condition
  • Cytostatic pre-treatment of ALL
  • Chemotherapy treatment of any other malignancy during the last 5 years
  • Participation in other clinical trials interfering with the study therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198978
Other Study ID Numbers  ICMJE GMALL02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johann Wolfgang Goethe University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dieter Hoelzer, MD,PhD University of Frankfurt, Medical Dept. II
PRS Account Johann Wolfgang Goethe University Hospital
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP