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Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by University Hospital Carl Gustav Carus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460447
First Posted: April 16, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Carl Gustav Carus
  Purpose

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


Condition Intervention Phase
Acute Myeloid Leukemia Allogeneic Transplantation Drug: Gemtuzumab Ozogamicin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gentuzumab Ozogamicin Berfore Allogeneic Stem Cell Transplantation in Patients With Relapsed CD33+ Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:
  • Documentation of the extramedullary toxicity of the standard therapy

Secondary Outcome Measures:
  • Induction of a persistent remission by the combination of Mylotarg and dose reduced conditioning followed by allogenic hematopoetic stem cell transplantation in patients with relapsed acute myelotic leukemia

Estimated Enrollment: 30
Study Start Date: October 2004
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - patients with acute myelotic leukemia and expression of CD33 on > 5% of blasts in bone marrow
  • relapse after chemotherapy
  • relapse after autologous or allogenic hematopoetic stem cell transplantation
  • pts. in 2nd remission after chemotherapy and ineligible for a conventional allogeneic transplantation
  • age: 18-70 years
  • informed consent of the patient
  • ASAT/ ALAT < 3fold of upper standard
  • Bilirubin < 2fold of upper standard
  • ejection fraction > 40% in echocardiography
  • potential donor in accordance with the following priorities:
  • 1st HLA-identical related donor (HLA *A, *B, *C and *DR)
  • 2nd HLA-identical non-related donor with the maximum of 1 allelmismatch (DNA typing A, B, C, DRB1, DQB1)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460447


Contacts
Contact: Martin Bornhäuser, MD +49351458 ext 4704 martin.bornhaeuser@uniklinikum-dresden.de

Locations
Germany
Medizinische Klinik und Poliklinik I Recruiting
Dresden, Germany, 01307
Sponsors and Collaborators
University Hospital Carl Gustav Carus
Investigators
Principal Investigator: Martin Bornhäuser, MD Medical Clinic, University Hospital Dresden
  More Information

ClinicalTrials.gov Identifier: NCT00460447     History of Changes
Other Study ID Numbers: EK 92062003
First Submitted: April 12, 2007
First Posted: April 16, 2007
Last Update Posted: October 12, 2017
Last Verified: April 2007

Keywords provided by University Hospital Carl Gustav Carus:
anti-CD33
Immunotoxin
Acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents