Safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma: a clinical phase I study

Safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma: a clinical phase I study - Safety of bendamustine-containing conditioning for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin's B-cell lymphoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012083

Enrollment

Registered

2013-10-21

Start date

2013-10-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Relapsed or refractory aggressive non-Hodgkin&#39

Interventions

A combination therapy of bendamustine, etoposide, cytarabine and melphalan as a conditioning regimen for autologous stem cell transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with aggressive non-Hodgkin's B-cell lymphoma who are refractory to/relapsed after one or more prior chemotherapies 2) Patients in PR or CR after salvage regimen 3) Patients whose CD34+ cells are collected at a dose of more than 2.0x10^6 cells/kg 4) Patients with ECOG PS 0-1 5) Patients with adequate liver function: AST <2.5x ULN, ALT <2.5x ULN, T-Bil <2x ULN (except for disease activity) 6) Patients with adequate renal function: GFR >50 ml/min 7) Patients with adequate pulmonary function: %VC >80%, FEV1.0/FVC >70% 8) Patients with adequate cardiac function: EF >50% (assessed on cardiac ultrasonography)

Exclusion criteria

Exclusion criteria: 1) Patients with concomitant active cancer 2) Patients with active viral hepatitis or HBs-Ag positive 3) Patients with known CNS involvement of the lymphoma 4) Patients with previous serious allergy to any of the drugs given 5) Patients with abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or poor compliance of antihypertensive treatment, uncontrolled arrhythmias 6) Patients with serious or uncontrolled medical condition such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease 7) Patients unable to give written informed consent 8) Others: Inappropriate patients determined by a principal investigator or sub-investigators

Design outcomes

Primary

Measure	Time frame
The maximum tolerated dose of bendamustine in a combination therapy with etoposide, cytarabine and melphalan	—

Countries

Japan

Contacts

Public ContactTakaaki Toyama

Keio University School of Medicine Division of Hematology

takt@a7.keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Safety of bendamustine-containing combination therapy as a conditioning regimen for autologous stem cell transplantation for relapsed/refractory aggressive non-Hodgkin&#39;s B-cell lymphoma: a clinical phase I study