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Study Evaluating the Efficacy of 90Yttrium-epratuzumab in Adults With CD22+ Relapsed/Refractory B-ALL

NCT02844530 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-01-19

No results posted yet for this study

Summary

The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370 MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for the expression of CD22 has been chosen in order to propose this protocol to all adults with CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be assessed in comparison with standard of care salvage chemotherapy regimens. Only three standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for the comparative analysis of clinical efficacy.

Conditions

  • CD22+ Relapsed/Refractory B-ALL

Interventions

DRUG

90Y-epratuzumab tetraxetan

The Primary objective is to compare the complete response rate (CR + CRp) after 2 injections of 370 MBq/m² of 90Y-epratuzumab tetraxetan RIT at day 1 and day 8 versus standard of care salvage chemotherapy regimens in adult CD22+ relapsed/refractory B-ALL. A second RIT cycle (consolidation) will be allowed in the experimental group in case of response (CR or CRp). From an ethical point of view, it will be also permitted to propose the RIT experimental treatment in the control group in case of treatment failure or relapse during the 6 months following inclusion. Follow-up will be also 12 months from the RIT for these patients

DRUG

chemotherapy/ immunotherapy

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02844530 on ClinicalTrials.gov