A Phase III Study Comparing Low Dose Cyclosporine, Methotrexate And Prednisone Versus Standard Dose Cyclosporine and Methotrexate As Graft Versus Host Disease Prophylaxis In Myeloblative Allogeneic Stem Cell Transplantation (ALLG BM10 trial).(Incorporating an Open-Label Sub-study Investigating The Use Of Valganciclovir In The Prevention Of Cytomegalovirus Infection In Hematopoietic Stem Cell Transplant Recipients (ML20712))

Phase 3

Withdrawn

• Conditions: Graft Versus Host Disease; Prophylaxis In Myeloblative; Allogeneic Stem Cell; Transplantation; Prevention Of Cytomegalovirus; Infection In Hematopoietic Stem; Cell Transplant Recipients; Surgery - Other surgery; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12607000347460
• 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: 2007-06-27
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

2. Presence of a haematological malignancy, for which myeloblative allogeneic haematopoietic stem cell transplant is considered appropriate therapy.3. Disease status: acute myeloblastic leukaemia, acute lymphoblastic leukaemia (ALLG), Philadelphia positive ALL in first or later complete remission, chronic myeloid leukaemia (CML), multiple myeloma, non-hodgkin’s lymphoma, Hodgkin’s lymphoma in first or later complete remission, myelodisplastic syndrome. Myelofibrosis and other haematological malignancies are also included. 4. Ability to give informed consent.5. Preserved functional status (Eastern Cooperative Oncology Group performance status <2).6. Left ventricular ejection fraction > 45%. 7. Diffusing capacity of the lung for carbon monoxide > 50% of normal on pulmonary function testing.8. Serum Creatinine <150 umol/L9. Serum Bilirubin < 40mmol/l, AST < 3 x upper limit of normal.10. Availability of a willing, 7/8 or 8/8 human leukocyte antigens (HLA) -matched sibling or unrelated stem cell donor matched at HLA A, B, C and DRB1 (One antigen mismatch at Class I is permissible if no other suitable donor is available).11. Ability to harvest > 2.0 x 106/kg CD34 peripheral blood stem cells.

Exclusion Criteria

1. Human immunodeficiency virus sero-positive2. Life expectancy less than 3 months.3. Psychiatric condition preventing the patient from providing informed consent.4. Pregnant or lactating women.5. History of active malignant disease within the previous 5 years excluding basal cell carcinoma or sqamous cell carcinoma of the skin.6. Previous allogeneic stem cell transplant7. More than 2 previous autografts

Study & Design

• Study Type: Interventional
• Study Design: Not specified