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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 on November 16, 2019

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
CD33 Positive Acute Myelogenous Leukemia
Sex
Females and Males
Age
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.
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- 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 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.

OR

- 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.

NCT02312037
Pfizer
No longer available
Expanded 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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Descriptive Information
Brief TitleExpanded 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

Contact:

[email protected]

Study TypeExpanded Access
InterventionBiological: 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 StatusNo longer available
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location CountriesSpain
 
Administrative Information
NCT NumberNCT02312037
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now