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


Last updated date
Study Location
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, 35233, United States


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
CD33 Positive Acute Myelogenous Leukemia
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3 + months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.


- Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.

- Documentation that malignant cells express CD33

4) Age >=3 months

5) Adequate non-hematologic organ function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Untreated AML and MDS or AML and MDS in complete remission.

- Patients with a known history of VOD/SOS.

- Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody,
calicheamicin derivatives or other ingredients.

- Participation in other studies involving investigational drug(s) (Phases 1-4) during
study participation.


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CD33 Positive Acute Myelogenous LeukemiaExpanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy
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3 Months+
Advanced Information
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: [email protected]

Detailed Description


[email protected]

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 * Wang ES, Aplenc R, Chirnomas D, Dugan M, Fazal S, Iyer S, Lin TL, Nand S, Pierce KJ, Shami PJ, Vermette JJ, Abboud CN. Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2020 Aug;61(8):1965-1973. doi: 10.1080/10428194.2020.1742897. Epub 2020 May 20.

*   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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2019