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Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT01310101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-02-03

No results posted yet for this study

Summary

The rationale of the study is to explore the safety and efficacy of ofatumumab in combination with dexamethasone (O-dex regimen) in patients with refractory/relapsed CLL. Moreover, the hypothesis is that this approach will be able to achieve at least the same response rates compared with R-dex regimens (historical controls; manuscript submitted to Leukemia), while maintaining lower toxicity profile.

Conditions

Interventions

DRUG

ofatumumab plus dexamethasone

Dose and schedule Cycle 1: Ofatumumab: 300 mg as an i.v. infusion on day 1 of the cycle; Ofatumumab: 2000 mg as an i.v. infusion on days 8, 15, 22; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18 Cycles 2 to 6 (cycles every 28 days): Ofatumumab: 1000 mg i.v. infusion on day 1, 8, 15 and 22 of the cycle; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18

Sponsors & Collaborators

  • University Hospital Hradec Kralove

    collaborator OTHER

  • Faculty Hospital Kralovske Vinohrady

    collaborator OTHER_GOV

  • General Teaching Hospital, Prague

    collaborator OTHER

  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Jiří Mayer, Prof., M.D. · University Hospital Brno, Department of Internal Medicine - Hematology and Oncology

  • Michael Doubek, A.Prof.,M.D. · University Hospital Brno, Department of Internal Medicine - Hematology and Oncology

  • Lukáš Smolej, M.D., Ph.D. · University Hospital Hradec Králové, Department of clinical hematology

  • Tomáš Kozák, Doc.,M.D. · University Hospital Královské Vinohrady, Department of clinical hematology

  • Petra Obrtlíková, M.D., Ph.D. · Charles University in Prague and General University Hospital in Prague, 1st Department of medicine - Department of hematology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01310101 on ClinicalTrials.gov