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study to evaluate the efficacy of a preparative regimen for transplantation in refractory/relapsed non-Hodgkin lymphoma patients.

Phase II multicentric study to evaluate the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed aggressive B-cell non-Hodgkin lymphoma patients.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-001246-14-IT
Enrollment
Unknown
Registered
2012-03-16
Start date
2011-06-08
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Adult agressive B-cell non-Hodgkin lymphoma patients. MedDRA version: 14.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: SOC Classification code 10005329 Term: Bloo

Interventions

Trade Name: LAVACT Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE CAS Number: 3543757 Concentration unit: mg/l milligram(s)/litre Concentration t

Sponsors

AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Aggressive B-Cell non-Hodgkin lymphoma patients either resistant or relapsed • Age >18 and 70% •Adequate hematologic, renal, pulmonary and hepatic function. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • HIV infection • HCV positivity •Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy • Pregnancy or nursing •Absence of patient’s written informed consent • Current uncontrolled infections •Intercurrent organ damage or medical problems that would interfere with therapy

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the 1-year complete remission (CR) rate.;Secondary Objective: • To assess the safety of the regimen • To assess the disease-free survival • To assess the overall survival;Primary end point(s): To assess the 1-year complete remission (CR) rate.;Timepoint(s) of evaluation of this end point: 1-year—

Secondary

MeasureTime frame
Secondary end point(s): • To assess the safety of the regimen • To assess the disease-free survival • To assess the overall survival;Timepoint(s) of evaluation of this end point: 100 days (safety) 3-years (event-free and overall survival).—

Countries

Italy

Contacts

Public ContactHematology Clinical Trial Office

Presidio Ospedaliero“San Salvatore/Ospedali Riuniti Marche Nord”

a.isidori@ospedalesansalvatore.it+390721364022

Outcome results

None listed

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