EUCTR2005-005719-83-ES
Active, not recruiting
Not Applicable
Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-Tlymphocyte-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 - ATGfamilystudy
niversitary Hospital Hamburg0 sites160 target enrollmentStarted: March 15, 2012Last updated:
ConditionsAcute lymphoblastic and myeloid leukemiaMedDRA version: 14.1Level: LLTClassification code 10000842Term: Acute lymphatic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAteGe-Fresenius
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- niversitary Hospital Hamburg
- 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
Similar Trials
Active, not recruiting
Phase 1
Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-thymocyte-globulin (ATG) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study - NDAcute myeloid leukemia in first or subsequent complete remissionMedDRA version: 9.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloidEUCTR2005-005719-83-ITAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI160
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 availableacute lymphoblastic and myeloid leukemiaMedDRA version: 8.1Level: LLTClassification code 10024330Term: Leukemia acuteEUCTR2005-005719-83-DEniversity Hospital Hamburg-Eppendorf160
Active, not recruiting
Phase 1
Prevention of graft-against-host disease in patients treated with allogeneic stem cell transplantation: Possible role of extracorporeal photophoresisGraft-versus-host disease (GVHD), both acute and chronic untill one year after allogeneic stam cell transplatationTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2017-000614-39-NOOSLO UNIVERSITY HOSPITAL HF156
Completed
Phase 1
PTCy and Ruxolitinib GVHD Prophylaxis in MyelofibrosisPrimary MyelofibrosisMyeloproliferative DisordersNCT02806375St. Petersburg State Pavlov Medical University20
Unknown
Phase 3
Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal CellsChronic Graft-Versus-Host DiseaseNCT02291770Guangdong Provincial People's Hospital130