Evaluation of 3 Different Doses of IV Busulfan

Acute Myeloid Leukemia Clinical Trial

— AAA  

Official title:

Prospective and Multicentre Evaluation of 3 Different Doses of IV Busulfan Associated With Fludarabine and Thymoglobuline in the Conditioning of Allogeneic Stem Cell Transplantation (SCT) From a Matched Related or Unrelated Donor in Patients With Poor Prognosis Myeloid Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01985061
• Other study ID #: AAA-IPC2011-003
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: 33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies.

The study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design.

In addition, this trial will associate four ancillary studies to the main clinical objective:

1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with poor prognosis myeloid malignancies:

• Myelodysplastic syndrome,

• Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),

• CR1 AML with poor risk cytogenetics

2. Adult patients: aged = 55 years up to 65 or < 55 years not eligible for myeloablative conditioning regimen based on Total Body Irradiation (TBI) or double alkylating agent combinations.

3. Availability of a HLA identical sibling or matched unrelated donor (10/10)

4. Affiliation to social security

5. Written Informed Consent

Exclusion Criteria:

1. History of previous Allo-Hematological Stem Cell Transplantation (HSCT)

2. HIV positivity

3. Signs of chronic active hepatitis B and/or C

4. Evolutive psychiatric disease

5. Concomitant neoplastic disease

6. Pregnant or lactating woman or without contraception (for child bearing potential wom-en)

7. Usual contra-indications for Allo-HSCT

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• BX2

• BX3

• BX4-Suspended
Suspended

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression or death	2-year progression free survival rates	up to 2 years
Secondary	Time to neutrophil>0.5G/l and platelets>50G/l	hematologic recovery	up to 2 months
Secondary	Graft versus host disease		up to 2 years
Secondary	relapse		up to 2 years
Secondary	Occurrence of grade 3-4 adverse events according the CTC-AE v4.0 scale	safety	up to 6 months

External Links

•   official web site of the sponsor