EUCTR2005-005719-83-DE
Active, not recruiting
Not Applicable
Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-T-lymphocyte-globulin (ATG Fresenius) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study - not available
niversity Hospital Hamburg-Eppendorf0 sites160 target enrollmentStarted: August 15, 2006Last updated:
Conditionsacute lymphoblastic and myeloid leukemiaMedDRA version: 8.1Level: LLTClassification code 10024330Term: Leukemia acute
DrugsATG Fresenius S
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- niversity Hospital Hamburg-Eppendorf
- Enrollment
- 160
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Acute myeloid leukemia in first or subsequent complete remission (de\-novo or secondary AML).
- •Acute lymphoblastic leukemia in first or subsequent complete remission.
- •Patient's age: 18 – 65 years.
- •Myeloablative standard conditioning.
- •HLA\-identical sibling (HLA\-A, HLA\-B, HLA\-DRB1 and HLA\-DQB1\).
- •No major organ dysfunctions.
- •Patient's written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •No complete remission at time of randomization.
- •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- •o Total bilirubin, SGPT or SGOT \> 5 times upper the normal level.
- •o Left ventricular ejection fraction \< 30 %.
- •o Creatinine clearance \< 30 ml/min.
- •o DLCO \< 35 % and/or receiving supplementary continuous oxygen.
- •Positive serology for HIV.
- •Pregnant or lactating women.
- •Serious psychiatric or psychological disorders.
- •Progressive invasive fungal infection at time of registration
Investigators
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