Status:
COMPLETED
Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)
Lead Sponsor:
medac GmbH
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based conditioning therapy with reduced intensity i.v. Busulfan-based conditioning in adult AML and MDS patients at increas...
Detailed Description
To compare efficacy and safety of Treosulfan-based conditioning (test) with i.v. Busulfan-based reduced intensity conditioning (reference). The statistical aim of the study is to show non-inferiority...
Eligibility Criteria
Inclusion
- Patients with acute myeloid leukaemia acc. to WHO, 2008 (AML in complete remission at transplant, i.e. blast counts \< 5 % in bone marrow) or myelodysplastic syndrome acc. to WHO, 2008 (MDS with blast counts \< 20 % in bone marrow during disease history) indicated for allogeneic haematopoietic progenitor cell transplantation but considered to be at increased risk for standard conditioning therapies according to the following criteria:
- patients aged ≥ 50 years at transplant and / or
- patients with a HCT-CI score \> 2 \[acc. to Sorror et al., 2005\]
- Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD). Donor selection is based on molecular high resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA- A, B, and C gene loci. In case, no class I and class II completely identical donor (10 out of 10 gene loci) can be identified, one antigen disparity (class I) and/or one allele disparity (class II) between patient and donor are acceptable. Conversely, disparity of two antigens (irrespective of the involved gene loci) cannot be accepted. These definitions for the required degree of histocompatibility apply to the selection of related as well as of unrelated donors.
- Adult patients of both gender, age 18 - 70 years
- Karnofsky Index ≥ 60 %
- Written informed consent
- Men capable of reproduction and women of childbearing potential must be willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter
Exclusion
- Patients with acute promyelocytic leukaemia with t(15;17)(q22;q12) and in CR1
- Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):
- patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine \> 3.0 x ULN or calculated creatinine-clearance \< 60 ml/min
- patients with severe pulmonary impairment, DLCOsb (Hb-adjusted)/or FEV1 \< 50 % or severe dyspnoea at rest or requiring oxygen supply
- patients with severe cardiac impairment diagnosed by echocardiography and LVEF \< 40 %
- patients with severe hepatic impairment indicated by hyperbilirubinaemia \> 3 x ULN or ALT / AST \> 5 x ULN
- Active malignant involvement of the CNS
- HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
- Previous allogeneic HSCT
- Pleural effusion or ascites \> 1.0 L
- Pregnancy or lactation
- Known hypersensitivity to treosulfan, busulfan and/or related ingredients
- Participation in another experimental drug trial within 4 weeks prior to day -6 of the protocol
- Non-cooperative behaviour or non-compliance
- Psychiatric diseases or conditions that might compromise the ability to give informed consent
Key Trial Info
Start Date :
November 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2018
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT00822393
Start Date
November 24 2008
End Date
January 25 2018
Last Update
July 30 2020
Active Locations (33)
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1
Helsinki University Central Hospital, Dept. of Medicine
Helsinki, Finland, 00290
2
Centre Hospitalier Lyon Sud
Lyon, France, 69495
3
Hopital Saint-Louis
Paris, France, 75475
4
Universitätsklinikum Koeln, Stammzelltransplantation
Cologne, Germany, 50937