Conditioning treatment with treosulfan or busulfan for chemotherapy prior to stem cell transplantation in patients with leukemia.
- Conditions
- Patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) considered ineligible to standard conditioning therapies prior to allogeneic stem cell transplantation.MedDRA version: 16.1Level: PTClassification code 10000881Term: Acute myeloid leukaemia (in remission)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-002356-18-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 960
1. 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 [according to Sorror et al., 2005]
2. 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 unrelated donors.
3. Adult patients of both gender, 18 – 70 years of age
4. Karnofsky Index = 60 %
5. Written informed consent
6. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 787
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 173
1. Patients with acute promyelocytic leukaemia with t(15;17)(q22;q12) and in CR1
2. 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 electrocardiogram and LVEF < 40 %
- patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN
3. Active malignant involvement of the CNS
4. HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
5. Previous allogeneic HSCT
6. Pleural effusion or ascites > 1.0 L
7. Pregnancy or lactation
8. Known hypersensitivity to treosulfan, busulfan and/or related ingredients
9. Participation in another experimental drug trial within 4 weeks prior to day –6 of the protocol
10. Non-cooperative behaviour or non-compliance
11. Psychiatric diseases or conditions that might compromise the ability to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method