Status:
TERMINATED
Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
MedImmune LLC
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of moxetumomab pasudotox that can be given to patients with relapsed and/or refractory ALL.
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of 3-6 participants will be enrolled ...
Eligibility Criteria
Inclusion
- Patients age 18 years or older with previously treated ALL (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (CD22) are also eligible to participate, Pediatric patients younger than 18 may be considered with sponsor approval once the MTD has been established in the adult population.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Adequate liver function (bilirubin less than or equal to 1.5 mg/dL and serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than or equal 2.5 x upper limit of normal (ULN), unless considered due to tumor or hemolysis), and renal function ( Calculated CrCl of greater than or equal to 50 or serum creatinine less than 2 x ULN.) Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dL (unless due to hemolysis or Gilbert's disease, i.e. mainly indirect bilirubin) and creatinine less than or equal 2 mg/dL
- Provision of written informed consent.
Exclusion
- Patient with active heart disease (NYHA class greater than or equal to 2 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either multigated radionuclide angiography (MUGA) or echocardiogram) less than 40%
- Patients with active hepatitis
- Pregnant or breast-feeding women. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of treatment.
- prior radioimmunotherapy within 3 years of enrollment
- serum albumin less than 2g/dL
- oxygen saturation at rest by pulse oximetry less than 88% or PaO2 less than or equal to 55mm Hg
- history of microangiopathic hemolysis, TTP or HUS.
- symptomatic central nervous system (CNS) involvement
- Less than 100 days post -transplant or any evidence of active graft-versus-host disease (GVHD)
- systemic chemotherapy less than 14 days prior; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the Principal Investigator
- monoclonal antibody therapy less than 1 month
- investigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the Principal Investigator
- HIV+/AIDS
- history of exposure to pseudomonas exotoxin containing molecule
- Patients with active lung infection or active pulmonary edema.
- Patients with laboratory findings consistent with Grade equal to greater than 3 disseminated intravascular coagulation (DIC) or any Grade 2 DIC that does not correct.
- Patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial
- Pre-treatment greater than corrected QT interval (QTc) interval of 490 ms
Key Trial Info
Start Date :
December 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2017
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01891981
Start Date
December 17 2013
End Date
April 12 2017
Last Update
October 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030