Comparison of two methods for the prevention of graft-versus-host reactions after bone marrow transplantation.

Phase 1

• Conditions: Hematologic malignancies treated by reduced-intensity conditioning allogeneic transplants.; MedDRA version: 18.0Level: PTClassification code 10001756Term: Allogenic bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: LLTClassification code 10018799Term: GVHDSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024297-19-BE
• Lead Sponsor: CHU de Liege

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-18
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Hematological malignancies confirmed histologically and not rapidly progressing:
- AML in CR (defined as = 5% marrow blasts and absence of blasts in the peripheral blood);
- MDS with = 5% marrow blasts and absence of blasts in the peripheral blood;
- CML in CP;
- MPS not in blast crisis and not with extensive marrow fibrosis,
- ALL in CR;
- Multiple myeloma not rapidly progressing;
- CLL;
- Non-Hodgkin’s lymphoma (aggressive NHL should have chemosensitive disease);
- Hodgkin’s disease with chemosensitive disease.
Clinical situations:
•Theoretical indication for a standard allo-transplant, but not feasible because:
- Age > 50 yrs;
- Unacceptable end organ performance;
- At the physician’s decision;
- Patient’s refusal.
•Indication for a standard auto-transplant:
-perform mini-allotransplantation 2-6 months after standard autotransplant.

•Other inclusion criteria
-Male or female; fertile patients must use a reliable contraception method;
-Age =75 yrs (children of any age are allowed in the protocol);
-Informed consent given by patient or his/her guardian if of minor age.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any condition not fulfilling inclusion criteria;
•HIV positive;
•Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT;
•Life expectancy severely limited by disease other than malignancy;
•Administration of cytotoxic agent(s) for cytoreduction” within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
•CNS involvement with disease refractory to intrathecal chemotherapy.
•Terminal organ failure, except for renal failure (dialysis acceptable)
-a.Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension;
-b.Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
-c.Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease;
•Uncontrolled infection;
•Karnofsky Performance Score <70%;
•Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
•Patient is a female who is pregnant or breastfeeding;
•Any condition precluding the use of sirolimus or MMF.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified