Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation

NCT00460447 | Unknown Phase 1

• 1 other identifier: EK 92062003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Acute Myeloid Leukemia; Allogeneic Transplantation

Keywords

anti-CD33; Immunotoxin; Acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Documentation of the extramedullary toxicity of the standard therapy

Secondary Outcomes (1)

• 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

Interventions

Gemtuzumab Ozogamicin DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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:
• st HLA-identical related donor (HLA \*A, \*B, \*C and \*DR)
• nd HLA-identical non-related donor with the maximum of 1 allelmismatch (DNA typing A, B, C, DRB1, DQB1)

Sponsors & Collaborators

• University Hospital Carl Gustav Carus: lead

Study Sites (1)

Medizinische Klinik und Poliklinik I

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Martin Bornhäuser, MD

  Medical Clinic, University Hospital Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Bornhäuser, MD

CONTACT

+49351458; martin.bornhaeuser@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 16, 2007
• Study Start: October 1, 2004
• Last Updated: April 16, 2007

Record last verified: 2007-04

Locations

DE (1)