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Clinical Trials/ACTRN12606000386538
ACTRN12606000386538
Completed
Phase 2

A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim or Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine Salvage Therapies in the Treatment of Relapsed/Refractory CD20+ Non-Hodgkin Lymphomas to Improve the Outcome of Quality of Life and to Minimise Inpatient Stay.

Associate Professor Andrew Spencer0 sites12 target enrollmentSeptember 4, 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Relapsed and refractory CD20+ lymphoma
Sponsor
Associate Professor Andrew Spencer
Enrollment
12
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 4, 2006
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Associate Professor Andrew Spencer

Eligibility Criteria

Inclusion Criteria

  • Relapsed or primary refractory CD20\+ NHL, ECOG 0 – 2, Written informed consent.

Exclusion Criteria

  • Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy, Bilirubin \> 50µmol/litre unless secondary to lymphoma, Creatinine \> 2 x upper limit of normal unless secondary to lymphoma, Absolute neutrophil count \<0\.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma, Relapse within 6 months of a prior transplant procedure (autologous or allogeneic), Known sensitivity to E coli derived preparations.

Outcomes

Primary Outcomes

Not specified

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