Pilot cml autograft/glivec (STI571)/Intron A trial

Phase 2

Recruiting

• Conditions: Advanced phase chronic myeloid leukaemia; Ph-positive acute lymphoblastic leukemia; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12605000071628
• 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
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Patients considered eligible for autologous transplantation by local institutional criteria. 2. Patients with a confirmed diagnosis of Ph chromosome-positive CML not in first chronic phase or Ph chromosome-positive ALL (or patients who are Ph chromosome-negative but BCR/ABL-positive). Patients with chronic phase Ph+ CML with development of resistance to Glivec will also be eligible. Patients with chronic phase CML who are primarily resistant to Glivec will also be eligible. 3. Cryopreserved autologous bone marrow or peripheral blood cells available which contain >2 x 106/L CD34+ cells or an equivalent number of CFU-GM/kg by local institutional criteria. 4. AST (SGOT) and ALT (SGPT) less than or equal to 3x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed. In patients with clinically suspected leukaemic involvement of the liver, AST and ALT less than or equal to 5x the ULN. 5. Total serum bilirubin level less than or equal to 3x the ULN at the laboratory where the analysis was performed. 6. Serum creatinine less than or equal to 1.5 x the upper limit of normal 7. Patients of childbearing potential must have a negative pregnancy test prior to the initiation of study drug. Patients will need to use barrier contraceptive measures throughout the trial 8. Written voluntary informed consent.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety of Glivec introduced early in the recovery phase post autograft.[Assessed in the first 1-3 months post initiation of therapy and then longer term assessment at 3,6,9,12 months post transplant and then long term follow up for as long as patients remain in study treatment.]