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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 (AML)

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ClinicalTrials.gov Identifier: NCT02312037
Expanded Access Status : No longer available
First Posted : December 9, 2014
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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


Condition or disease Intervention/treatment
CD33 Positive Acute Myelogenous Leukemia Biological: Antibody Drug Conjugate Chemotherapeutic

Detailed Description:

Contact:

B1761026@iconplc.com

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Study Type : Expanded Access
Official Title: GEMTUZUMAB OZOGAMICIN (MYLOTARG (REGISTERED)) EXPANDED ACCESS PROTOCOL FOR TREATMENT OF PATIENTS IN THE UNITED STATES WITH RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA WHO MAY BENEFIT FROM TREATMENT AND HAVE NO ACCESS TO OTHER COMPARABLE/ALTERNATIVE THERAPY



Intervention Details:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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:

  • 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.

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): NCT02312037


Locations
Show Show 142 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02312037    
Other Study ID Numbers: B1761026
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Pfizer:
Relapsed CD33 AML
Refractory CD33 AML
Relapsed CD33 APL
Refractory CD33 APL
Relapsed CD33 MDS
Refractory CD33 MDS
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antibodies
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents