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PHASE II STUDY OF 90Y-IBRITUMOMAB TIUXETAN AND FOTEMUSTINE ASSOCIATED WITH CYTARABINE ETOPOSIDE MELPHALAN AS CONDITIONING CHEMORADIOIMMUNOTHERAPY IN PATIENTS AFFECTED BY LYMPHOMA (HODGKIN AND NON-HODGKIN) CD20+ REFRACTORY/RELAPSED WITH MINIMAL RESIDUAL PERSISTANT DISEASE PRE-AUTOLOGOUS TRANSPLANT - Z-FEAM

PHASE II STUDY OF 90Y-IBRITUMOMAB TIUXETAN AND FOTEMUSTINE ASSOCIATED WITH CYTARABINE ETOPOSIDE MELPHALAN AS CONDITIONING CHEMORADIOIMMUNOTHERAPY IN PATIENTS AFFECTED BY LYMPHOMA (HODGKIN AND NON-HODGKIN) CD20+ REFRACTORY/RELAPSED WITH MINIMAL RESIDUAL PERSISTANT DISEASE PRE-AUTOLOGOUS TRANSPLANT - Z-FEAM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006899-30-IT
Enrollment
Unknown
Registered
2008-12-15
Start date
2008-12-05
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

PATIENTS <= 65 YEARS AFFECTED BY LYMPHOMA (HODGKIN AND NON-HODGKIN) CD20+ REFRACTORY/RELAPSED WITH MINIMAL RESIDUAL PERSISTANT DISEASE PRE-AUTOLOGOUS TRANSPLANT MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell MedDRA version: 9.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease

Interventions

Trade Name: ZEVALIN Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Ibritumomab tiuxetan(90Y) Concentration unit: MBq megabecquerel(s) Concentration type: equal

Sponsors

ISTITUTI FISIOTERAPICI OSPITALIERI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PATIENTS = 70 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 F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: SECOND CONCOMITANT NEOPLASM HIV SEROPOSITIVITY

Design outcomes

Primary

MeasureTime frame
Main Objective: TO ESTABILISH FACTIBILITY AND SAFETY OF Z-FEAM BY ASSESSMENT: 1. HEMATOLOGICAL AND EXTRA-HEMATOLOGICAL TOXICITY 2. TRANSPLANT RELATED MORTALITY 3. MYELOID RECOVERY 4. IMMUNOLOGICAL RECONSTITUTION;Secondary Objective: TREATMENT EFFICACY IN TERMS OF: 1. COMPLETE RESPONSE 2. PROGRESSION FREE SURVIVAL 3. EVENT FREE SURVIVAL 4. OVERALL SURVIVAL;Primary end point(s): HEMATOLOGICAL AND EXTRAHEMATOLOGICAL TOXICITY RATE—

Countries

Italy

Outcome results

None listed

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