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Autologous peripheral blood stem cell transplantation as consolidation for high risk diffuse large B-cell lymphoma:A phase II study

Autologous peripheral blood stem cell transplantation as consolidation for high risk diffuse large B-cell lymphoma:A phase II study - Up-front transplantation for high risk diffuse large B-cell lymphoma:A phase II study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012546
Enrollment
18
Registered
2014-01-06
Start date
2014-01-06
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

Diffuse Large B-Cell Lymphoma:IPI high risk group, CR1

Interventions

A high dose chemotherapy (ex.MCEC) combination therapy followed by autologous peripheral blood stem cell transplantation

Sponsors

Nishiwaki Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ECOG 0-1 3. Cardiac: LV Ejection fraction>40% by Echocardiogram 4. Pulmonary: SpO2>94% and FEV1.0%>70%. 5. Hepatic: total bilirubin>2.0mg/dl and AST>2.5x ULN. 6. Renal: Serum creatinine clearance>30ml/min

Exclusion criteria

Exclusion criteria: 1.Drug allergy used for conditioning regimen. 2.Positive HBs antigen or seropositive to HIV.(Not exclude for seropositive to HCV) 3.Uncontrolled infection. 4.Patients inappropriate for transplantation with reasons other than above.

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival and the treatment-related toxicity

Secondary

MeasureTime frame
-Relapse rate within one year after the transplant -Non-relapse mortality rate within one-year after the transplant -1-year disease-free survival -2-year overall survival rate

Countries

Japan

Contacts

Public ContactTakao Kashiwagi

Nishiwaki Municipal Hospital Department of Medicine

byoin@hospital.city.nishiwaki.hyogo.jp81-795-22-0111

Outcome results

None listed

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