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Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation

NCT00460447 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-04-16

No results posted yet for this study

Summary

Study Design:

prospective phase II trial with 30 patients in 1 site

Treatment Scheme:

Option 1: Patient \< 60 years of age with relapse after chemotherapy or \> 12 months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14 Fludarabin 30 mg/ m² day -6 to -3 TBI 2x2 Gy day -3 to -2 (total dose 8 Gy) Tacrolimus (level adapted) from day -3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to day 40 PBSC day 0

Option 2: Patient \> 60 years of age or younger patients \< 12 Months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14 Fludarabin 30 mg/ m² day -3 to -1 TBI 1x2 Gy day 0 (total dose 2 Gy) Tacrolimus (level adapted) from day -3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to 40 PBSC day 0

Conditions

Interventions

DRUG

Gemtuzumab Ozogamicin

Sponsors & Collaborators

  • University Hospital Carl Gustav Carus

    lead OTHER

Principal Investigators

  • Martin Bornhäuser, MD · Medical Clinic, University Hospital Dresden

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31

Countries

  • Germany

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 NCT00460447 on ClinicalTrials.gov