Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02312037
Previous Study | Return to List | Next Study

Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy (AML)

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.
ClinicalTrials.gov Identifier: NCT02312037
Expanded Access Status : No longer available
First Posted : December 9, 2014
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 4, 2014
First Posted Date December 9, 2014
Last Update Posted Date September 17, 2018
 
Descriptive Information
Brief Title Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
Brief Summary

An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.

Contact: B1761026@iconplc.com

Detailed Description

Contact:

B1761026@iconplc.com

Study Type Expanded Access
Intervention Biological: Antibody Drug Conjugate Chemotherapeutic

Three Treatment Regimens:

  1. Mylotarg <=9 mg/m2 as a single agent on Day 1 & 14 of a 28-day cycle for a total of two cycles
  2. Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen
  3. Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL
Other Name: Gemtuzumab ozogamicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Spain
 
Administrative Information
NCT Number NCT02312037
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018