Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)

• Status: Terminated
• Trial end date: 2017-04-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: MedImmune LLC
• Treatments: Immunotoxin HA22

Criteria

Inclusion Criteria:

1. 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.

2. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.

3. 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

4. Provision of written informed consent.

Exclusion Criteria:

1. Patient with active heart disease (NYHA class greater than or equal to 2 as assessed by history and physical examination).

2. Patients with a cardiac ejection fraction (as measured by either multigated radionuclide angiography (MUGA) or echocardiogram) less than 40%

3. Patients with active hepatitis

4. 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.

5. prior radioimmunotherapy within 3 years of enrollment

6. serum albumin less than 2g/dL

7. oxygen saturation at rest by pulse oximetry less than 88% or PaO2 less than or equal to 55mm Hg

8. history of microangiopathic hemolysis, TTP or HUS.

9. symptomatic central nervous system (CNS) involvement

10. Less than 100 days post -transplant or any evidence of active graft-versus-host disease (GVHD)

11. 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

12. monoclonal antibody therapy less than 1 month

13. 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

14. HIV+/AIDS

15. history of exposure to pseudomonas exotoxin containing molecule

16. Patients with active lung infection or active pulmonary edema.

17. 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.

18. Patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial

19. Pre-treatment greater than corrected QT interval (QTc) interval of 490 ms