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
Contact: B1761026@iconplc.com
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
Detailed Description
Contact:
B1761026@iconplc.com
B1761026@iconplc.com
Conditions
CD33 Positive Acute Myelogenous Leukemia
Eligibility 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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Relapsed CD33 AML
Refractory CD33 AML
Relapsed CD33 APL
Refractory CD33 APL
Relapsed CD33 MDS
Refractory CD33 MDS
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
3 Months
NCT Id
NCT02312037
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
B1761026
Overall Status
No longer available
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
See Also Links
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Olga Derman
Investigator Email
ODERMAN@montefiore.org
Investigator Phone
MeSH Terms
GEMTUZUMAB
CALICHEAMICINS
AMINOGLYCOSIDES
GLYCOSIDES
CARBOHYDRATES
ANTIBODIES, MONOCLONAL, HUMANIZED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS