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

• ClinicalTrials.gov Identifier: NCT00198978
• Recruitment Status: Unknown
• First Posted: September 20, 2005
• Last Update Posted: June 5, 2008
• Sponsor: Johann Wolfgang Goethe University Hospital
• Information provided by: Johann Wolfgang Goethe University Hospital

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 20, 2005
• Last Update Posted Date: June 5, 2008
• Study Start Date: January 2003
• Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 28, 2006): Remission rate (cytologic, Remission rate (molecular), Survival time, Duration of Remission, Toxicity (CTC, Treatment realization

Original Primary Outcome Measures (submitted: September 12, 2005)

• - Remission rate (cytologic)
• - Remission rate (molecular)
• - Survival time
• - Duration of Remission
• - Toxicity (CTC)
• - Treatment realization

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adult Acute Lymphocytic Leukemia

Intervention

• 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: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 29, 2008): 200
• Original Enrollment (submitted: September 12, 2005): 120
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00198978
• Other Study ID Numbers: GMALL02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Johann Wolfgang Goethe University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Dieter Hoelzer, MD,PhD; University of Frankfurt, Medical Dept. II

• PRS Account: Johann Wolfgang Goethe University Hospital
• Verification Date: June 2008