Phase II single centre study assessing the efficacy and safety of I-131 rituximab radioimmunotherapy of relapsed or refractory diffuse large B cell lymphoma.

Phase II single centre study assessing the efficacy and safety of I-131 rituximab radioimmunotherapy of relapsed or refractory, CD 20 positive, diffuse large B cell lymphoma, with the primary objective tumour response.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000236695

Acronym

RITRAL

Enrollment

Registered

2005-08-26

Start date

2005-11-09

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

To evaluate the efficacy and the safety of I-131 rituximab in relapsed large B cell lymphoma administered as induction treatment and followed by standard non-radioactive rituximab as consolidation and maintenance treatment for one year in 40 patients in a single centre phase II open-label non-randomised study.

Interventions

I-131 rituximab administered as tracer dosimetry and a therapeutic dose followed by consolidation and maintenance unlabelled rituximab, 2 monthly for one year.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Histologically proven CD 20 positive diffuse large B cell lymphoma, previously treated with a chemotherapy regimen with or without rituximab in patients who have relapsed or are refractory; with a minimum life expectancy of 3 months.

Exclusion criteria

Pre-exisiting myelodysplasia.

Outcome results