Phase III Clinical Study of Allogeneic Stem CellTransplantation with Reduced Conditioning (RICT)versus Best Standard of Care in Acute Myeloid Leukemia(AML) in First Complete Remissio

Phase 3

Completed

• Conditions: Acute Myeloid Leukaemia; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12614000351617
• Lead Sponsor: Australasian Leukaemia & Lymphoma Group (ALLG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-02
• Study Completion: 2018-06-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. AML of intermediate or poor prognosis
2. Age 51 – 70 years.
3. Achieved CR1 or CRi.
4. Indication for a RIC but not a myeloablative alloSCT.
5. Judged to be able to tolerate a RICT if a suitable donor (MSD and/or MUD) is found.
6. Judged to be able to tolerate further standard consolidation chemotherapy.
7. Willing to undergo a RICT if a suitable donor is found.
8. Signed informed consent.
9. Willing and able to comply with protocol requirements.
10. Registration Form filled in and sent before initiation of donor search.

Exclusion Criteria

1. AML with good risk features.
2. Planned to receive full dose conditioning.
3. Initiation of donor search performed before registration in the study.
4. Additional malignancy that might interact with the endpoints of the study.
5. Serum creatinine > 2 x the ULN, or abnormal liver function; ALT or AST > 3 x ULN.
6. Other severe concurrent illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine in a group of elderly AML CR1 patients with a potential matched sibling donor (MSD) whether a reduced intensity conditioning transplantation<br>(RICT) leads to a superior overall survival compared to standard of care. Overall survival (OS) is defined as the time interval between the date of inclusion and the date of death from any cause. <br>[Primary endpoint is Overall Survival-Patients in both groups will be followed for survival, relapse and quality of life for a minimum of two<br>years.]