European Leukemia Trial Registry
Trial: ALL GMALL Imatinib post SZT

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Public Title pre-emptive vs. (MRD)-triggered administration of Imatinib after stem celltransplantation for Ph+/BCR-ABL+ALL
Scientific Title A randomized, multicenter phase III-study to compare the efficacy and safety of early pre-emptive versus minimal residual disease (MRD)-triggered administration of Imatinib Mesylate (STI571, Glivec) after stem cell transplantation for Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL).
Short Title ALL GMALL Imatinib post SZT
Id KN/ELN LN_GMALLE_2004_62
Trialgroup GMALL
Type of Trial multicentric, randomized
Phase Phase III
Disease Acute lymphoblastic leukemia(ALL) Stem cell transplantation
Acute lymphoblastic leukemia(ALL) Ph/BCR ABL +
Stage of Disease .
Category stem cell transplantation
Inclusion Criteria
  • Male or female patients ≥ 18 years of age
  • Patients with a confirmed diagnosis of Philadelphia chromosome-positive ALL (Ph+ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis (LyBC) who underwent allogeneic or autologous stem cell transplantation no longer than 6 weeks prior to randomization
  • Hematologic recovery to platelets >50/nl and ANC> 1x109/L
  • Complete hematologic remission demonstrated by bone marrow cytology or histology
  • Negative pregnancy test in all patients of childbearing potential prior to the initiation of study drug. Barrier contraceptive precautions are to be used throughout the trial in both sexes
  • Voluntary written informed consent.
Exclusion Criteria
  • Patients with an ECOG Performance Status Score ≥ 3
  • Creatinine levels more than 2x¡¯s the ULN at the laboratory where the analysis was performed.
  • Total serum bilirubin more than 2 x¡¯s the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
  • AST (SGOT) or ALT (SGPT) more than 5x¡¯s the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
  • Graft versus host disease WHO grade IV
  • Patients with NYHA grade 3/4 cardiac disease.
  • Patients with an active severe infection or any serious concomitant medical condition.
  • Patients with psychiatric disease or a history of non-compliance to medical regimens or who are considered potentially unreliable.
Age >= 18 years
Status Closed
Start of Recruitment 01.06.2004
Recruiting Countries Germany
Target Sample Size 80
Leader Ottmann, Prof. Dr., Oliver
Scientific Contact Ottmann, Prof. Dr., Oliver (Affliliation)
Contact Person

Study Physician
Bug, PD Dr. med., Gesine
Tel: +49 (0)69 6301 7369
Fax: +49 (0)69 6301 7463
Email: g.bug@em.uni-frankfurt.de

Centre of Trial Universitätsklinikum Frankfurt
Shortprotocol Shortprotocol
Diagnostics

MRD-Analysis
Molekulargenetik-Labor der Med.Klinik II, Universitätsklinikum Frankfurt

STI-Level Measurement
Pharmakokinetisches Labor, Universitätsklinikum Dresden (HPLC-Labor 10D)

Cytogenetics
Tumorzytogenetik-Labor, Universität Düsseldorf

Sponsors Universitätsklinikum Frankfurt
Supporters Universitätsklinikum Frankfurt
Outcomes
  • Molecular or hematologic relapse during therapy (Primary Outcome)
  • Time to conversion to MRD positivity after therapy
  • Overall survival after therapy
  • Disease free survival after therapy
  • Transplantant-related mortality during and after sct
  • Frequency of graft failure after sct
  • Rate and severity of acute and chronic GvHD after sct
  • Severe non-hematologic toxicity during therapy
  • Grade III/IV hematologic toxicity during therapy
Interventions
  • Imatinib: according to protocol
created 07.07.2006 Anja Hellenbrecht
changed 03.05.2018 Student Studienregister
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