Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial)

Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with conditioning regimen consisted of fludarabine, iv busulfan, and melphalan (single center prospective trial) - Allogeneic stem cell transplantation for relapsed/refractory aggressive lymphoma with fludarabine, iv busulfan, and melphalan.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013940

Enrollment

Registered

2014-05-13

Start date

2014-02-19

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 lymphomas (NHL)

Interventions

Allogeneic stem cell transplantation with conditioning regimen consisted of fludarabine 180 mg/m2, iv busulfan 12.8 mg/kg, and melphalan 80 mg/kg.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Candidates for allogeneic stem cell transplantation who fulfill each criteria. 1) ECOG performance status: 0-2, no severe organ dysfunction. 2) Relapse or refractory aggressive NHL (progressive disease during first-line chemotherapy, early relapse (<12 mo) after first-line chemotherapy, less than PR with salvage chemotherapy, relapse after high dose chemotherapy associated with autologous hematopoietic stem cell transplantation, mobilization failure) 3) >=stable disease with recent salvage chemotherapy. 4) Donor availability: HLA A/B/DR 6-locus matched related/unrelated bone marrow, related peripheral blood, cord blood >=2x10^7/kg with disparity <=2 antigens.

Exclusion criteria

Exclusion criteria: Positive for anti-HIV antibody Active double cancer Severe mental conditions Active infectious disease Known hypersensitivity to drugs to be used in the protocol. Not appropriate for enrollment as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
Survival rate with engraftment on day 60 after transplantation	—

Secondary

Measure	Time frame
Survival rate with engraftment on day 100. Grade>=3 AEs from start of conditioning to day 100 after transplantation. Non relapse mortality at day 100, 12 months after transplantation. Relapse rate at day 100, 12 months after transplantation. Event free survival rate at 12 months after transplantation. Overall survival at 12 months after transplantation. Rate of infectious disease at 12 months after transplantation. Rate and severity of acute or chronic graft-versus-host disease at 12 months after transplantation.	—

Measure

Time frame

Survival rate with engraftment on day 100. Grade>=3 AEs from start of conditioning to day 100 after transplantation. Non relapse mortality at day 100, 12 months after transplantation. Relapse rate at day 100, 12 months after transplantation. Event free survival rate at 12 months after transplantation. Overall survival at 12 months after transplantation. Rate of infectious disease at 12 months after transplantation. Rate and severity of acute or chronic graft-versus-host disease at 12 months after transplantation.

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Countries

Japan

Contacts

Public ContactKoji Izutsu

Toranomon Hospital Department of Hematology

izutsu-tky@umin.ac.jp03-3588-1111

Outcome results

None listed

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