Conditioning with Thiotepa, Busulfan and Fludarabin following allogeneic Transplantation in refractory or relapsed non Hodgkin lymphomas patients

Allogeneic Transplantation after a Conditioning with Thiotepa, Busulfan and Fludarabin for the treatment of refractory/early relapsed aggressive B-cell non Hodgkin lymphomas: a Phase II Multi-Center Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005378-73-IT

Enrollment

Registered

2013-01-11

Start date

2013-01-29

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Refractory/early relapsed aggressive B-cell non Hodgkin lymphomas MedDRA version: 14.1 Level: PT Classification code 10003899 Term: B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: THIOPLEX*INIET 1F 15MG Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: THIOTEPA CAS Number: 52-24-4 Concentration unit: mg milligram(s) Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy. •Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy •Patients younger than 65 years old •A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered •Patient must be competent to give consent 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 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Patients treated with an autologous transplant as salvage therapy •Patients with progressive lymphomas despite conventional therapies •Patients with progressive lymphomas despite conventional therapies •Uncontrolled CNS involvement with disease •Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment •Females who are pregnant or breastfeeding •Organ dysfunction defined as follows: ?Cardiac function: ejection fraction 3 mg/dl and/or transaminases >4x the upper limit of normal ?Renal: creatinine clearance 20% risk of disease recurrence

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression free survival;Secondary Objective: -Transplant-related morbidity (TRM) at day +100 and at +365 -Overall survival -Incidence of acute and chronic GVHD;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: 3 years	—

Secondary

Measure	Time frame
Secondary end point(s): -Transplant-related morbidity (TRM) at day +100 and at +365 -Overall survival -Incidence of acute and chronic GVHD;Timepoint(s) of evaluation of this end point: 3 years	—

Countries

Italy

Contacts

Public ContactUFFICIO SPERIMENTAZIONI CLINICHE

FO.NE.SA.ONLUS

gismm2001@yahoo.com+39 0116336107

Outcome results

None listed

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