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Safety Study to Assess AFM11 in Patients With Relapsed or Refractory Adult B-precursor ALL

NCT02848911 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-06-19

No results posted yet for this study

Summary

The purpose of the study is to determine the maximum tolerated dose (MTD) in patients with acute lymphoblastic leukemia (ALL) and to determine the safety and tolerability of increasing doses and different infusion times of AFM11 infusion in patients with adult B-precursor ALL

Conditions

  • Leukemia, B-Cell

Interventions

DRUG

AFM11

Accelerated-titration dose-escalation with 1 patient per dose-level, followed by standard dose-escalation (3 + 3 design), Treatment duration: 2 weeks

Sponsors & Collaborators

  • Affimed GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-09-30
Completion
2019-04-30

Countries

  • Austria
  • Czechia
  • Israel
  • Poland
  • Russia

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 NCT02848911 on ClinicalTrials.gov