Glivec plus chemotherapy in blast-phase CML and Ph+ A

Phase 2

Completed

• Conditions: Blast-Phase Chronic Myeloid Leukemia; Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia; Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia

• Registration Number: ACTRN12605000072617
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-04
• Study Completion: 2008-12-31
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Patients with a confirmed diagnosis of Ph+ CML in myeloid or lymphoid blast crisis, defined by the presence of the Philadelphia chromosome or Bcr-Abl fusion transcript and one or both of the following: i) >30% blasts in peripheral blood and/or bone marrow ii) Presence of extramedullary disease other than spleen and/or liver involvement (i.e. chloromas) OR Patients with a confirmed diagnosis of Ph+ ALL 2. Patients of childbearing potential must have a negative pregnancy test prior to the initiation of therapy. Male and female patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following the discontinuation of Glivec. 3. Written informed consent.

Exclusion Criteria

1. Exposure to any other investigational agents within 30 days of commencing Glivec 2. Known sensitivity to Glivec or the phenylaminopyrimidine class of drugs 3. ECOG Performance Status Score > 2 (Appendix 1) 4. Left ventricular ejection fraction < 50% on a radionuclide cardiac scan or echocardiogram 5. Creatinine > 1.5 ´ the upper limit of normal (ULN) at the laboratory where the analysis was performed 6. Serum bilirubin > 2 ´ ULN 7. AST or ALT > 2.5 ´ ULN. In patients with suspected leukaemic involvement of the liver, AST or ALT > 5 ´ ULN. 8. Known HIV seropositivity 9. Any serious concomitant medical condition that could, in the opinion of the Investigator, compromise participation in the study 10. Pregnancy or breastfeeding 11. Dementia, intellectual impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of Glivec (STI571) at 600 mg daily in combination with induction chemotherapy in adult patients with CML in blast crisis or Ph+ ALL during the first 2 months of treatment[ During the first 2 months of treatment]

Secondary Outcome Measures

Name	Time	Method
1. To investigate the efficacy of Glivec combined with induction chemotherapy in Ph+ acute leukaemias. This will be evaluated in terms of response rate (haematological, cytogenetic and molecular)[ At 4 weeks, leukaemia-free survival and overall survival at 3 years.];2. To examine the inhibition of Bcr-Abl kinase activity in leukaemic blasts induced in-vivo by Glivec. This will be determined using Western blot analysis.[ ]