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

Leukemia Clinical Trial

Official title: Phase I/II Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)

Status Terminated

Clinical Trial 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.

Clinical Trial 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 in the Phase 1 portion of the study.

If you are in Phase 1, the dose of moxetumomab pasudotox you receive will depend on when you join the study. The first group will receive the lowest dose level of moxetumomab pasudotox. Each additional group will receive a higher dose than the previous group, if no intolerable side effects were seen.

If you are in Phase 2, you will receive the highest dose of moxetumomab pasudotox found to be safe in the Phase 1 portion of the study.

Study Drug Administration:

You will receive moxetumomab pasudotox by vein on Days 1, 3, 5, 7, 9, and 11 of each 21-day cycle. You may be treated in the hospital for the first cycle. If your doctor thinks it is needed, the length of study cycles may be changed.

You may receive drugs to control side effects one hour before your dose of the study drug and up to 12 hours after your dose of the study drug. You may also receive fluids for hydration before and after your dose of the study drug.

Study Visits:

Every week during Cycle 1, blood (about 1 tablespoon) will be drawn for routine tests.

Within 1 week before Day 1 of each study cycle:

• You will have a physical exam.

• Blood (about 2 tablespoons) will be drawn for routine tests.

• If your doctor thinks it is needed, you will have an eye exam.

• Blood (about 2 teaspoons) will be drawn to test for drug antibodies.

On Day 1 (1st dose) of Cycle 1, before and right after your first dose of study drug and then 4-5 more times over the next 8 hours, blood (about 1/2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. At the 6th dose, blood (about 1/2 teaspoon each time) will be drawn before and right after your dose of study drug for PK testing. PK testing for the 1st and 6th dose will be repeated for Cycle 2 and every 4th treatment cycle until the end of treatment.

If the doctor thinks the disease is responding to the study drug, blood (about 1 tablespoon) will be drawn at least 1 time every week for routine tests.

Between Days 14-21 (+/- 7 days) of Cycle 1, you will have a bone marrow biopsy/aspiration. You will have additional bone marrow biopsy/aspirations every 2-4 cycles after that, and then every 3 months for up to 1 year during the follow-up period.

At the end of each cycle, urine will be collected for routine tests.

After your last dose of study drug, blood (about 2 teaspoons) will be drawn to test for drug antibodies.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. If your doctor thinks the disease is responding, you may receive up to 6 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visit:

About 30 days after the last dose of the study drug, you will be asked to return to the clinic for follow-up tests. During this visit, you may have blood drawn and other tests performed to check the status of the disease, to test for drug antibodies, and to check your health.

If you cannot come to MD Anderson, you will be contacted by phone and asked about your health.

This is an investigational study. Moxetumomab pasudotox is not FDA approved or commercially available. At this time, it is being used for research purposes only.

Up to 60 patients will take part in the study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT01891981
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 1
• Start date: December 17, 2013
• Completion date: April 12, 2017