A multicenter phase II trial of Recipient pre-treatment with Short-Term Rapamycin for the prevention of acute GVHD after hematopoietic stem cell transplantation in Elderly Patients - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002310-22-IT

Enrollment

Registered

2008-06-25

Start date

2008-06-16

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease MedDRA version: 9.1 Level: LLT Classification code 10048396 Term: Bone marrow transplant rejection MedDRA version: 9.1 Level: LLT Classification code 10000802 Term: Acute GVH disease

Interventions

Trade Name: RAPAMUNE*100CPR RIV 2MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed informed consent Age > 55 years Bone Marrow or PBSC graft HLA-identical or 1 antigen-mismatched donor Early disease (non neoplastic disease, AML or ALL in 1st complete remission, CML in 1st chronic phase, chemosensitive Lymphoma or Myeloma) Reduced Intensity Conditioning (RIC) regimen Normal renal or hepatic function 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

Exclusion criteria: Unable to sign informed consent Age 1 HLA antigen mismatched donor Advanced disease (based on above definitions of early disease) Myeloablative conditioning Renal failure (creatinine > 2 mg/dL or creatinine clearance 5 times normal or bilirubin > 3 mg/dL) HBV, HCV or HIV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: Te evaluate the incidence of acute GVHD grade II-IV.;Secondary Objective: To evaluate: time to acute GVHD grade II-IV incidence of acute GVHD any grade time to acute GVHD any grade overall survival, relapse rate incidence of chronic GVHD time to chronic GVHD Biological end points include the monitoring of the phenotype and function of peripheral blood lymphocytes and APC.;Primary end point(s): Te evaluate the incidence of acute GVHD grade II-IV.	—

Measure

Time frame

Main Objective: Te evaluate the incidence of acute GVHD grade II-IV.;Secondary Objective: To evaluate: time to acute GVHD grade II-IV incidence of acute GVHD any grade time to acute GVHD any grade overall survival, relapse rate incidence of chronic GVHD time to chronic GVHD Biological end points include the monitoring of the phenotype and function of peripheral blood lymphocytes and APC.;Primary end point(s): Te evaluate the incidence of acute GVHD grade II-IV.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026