Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title: Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

Status Completed

Clinical Trial Summary

You are being asked to take part in this study because you either had Ph positive B-lineage acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently received an allogeneic stem cell transplant (cells from someone else).

The goal of this clinical research study is to learn if blinatumomab in patients who have had an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in patients who either have a small amount of ALL or have had ALL in the past. The safety of this drug will also be studied.

Clinical Trial Description

Study Drug Administration:

Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle will start around 3, 6, 9, and 12 months after your stem cell transplant.

In each cycle, you will receive blinatumomab as a continuous infusion by vein for 4 weeks, followed by a 2 week "rest period" during which you will not receive blinatumomab.

You will need to remain in the hospital for the first 2 cycles so that you can be checked on for side effects.

Length of Study:

You may receive blinatumomab for up to 1 year. You will no longer be able to receive the study drug if the disease comes back (if you do not have ALL), if the disease gets worse (if you have a small amount of ALL), if intolerable side effects occur, or if you are unable to follow study directions.

Study Visits:

Before each cycle:

• You will have a physical exam. As part of the physical exam, you will be checked for graft versus host disease (GVHD, when transplanted donor tissue attacks the tissues of the recipient's body).

• Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell transplant.

• You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing.

Once a week during each cycle, blood (about 4 tablespoons) will be drawn for routine tests.

End of Study Visit:

About 2 weeks after your last dose of blinatumomab:

• You will have a physical exam.

• Blood (about 4 tablespoons) will be drawn to learn the effectiveness of the stem cell transplant.

• You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing.

This is an investigational study. Blinatumomab is FDA approved and commercially available for the treatment of Philadelphia chromosome (Ph) negative B-ALL that has returned after treatment. Its use in patients with Ph positive B-lineage ALL is investigational.

Up to 30 participants will be enrolled in this study. All will take part at MD Anderson. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02807883
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Completion date: February 1, 2022