IPI-145 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

Leukemia Clinical Trial

Official title: Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With IPI-145

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied.

Clinical Trial Description

Study Drug Administration:

If patient is found to be eligible to take part in this study, they will receive IPI-145 by mouth twice a day for a month (30 days). Patient should swallow IPI-145 whole with a glass of water (about 8 ounces). If patient forgets to take a dose or if they vomit, they should not take another dose.

Each study cycle lasts 30 days.

Patient's dose of the study drug may change depending on any side effects they may have.

Study Visits:

Patient will have a physical exam within 1 week before Day 1 of each study cycle.

The first 2 cycles are called induction and all cycles after that are called consolidation cycles. Blood (about 1 tablespoon each time) will be drawn 1 to 3 times a week during induction (Cycles 1 and/or 2) and then at least 1 time a week during consolidation. How often blood will be drawn will be based on the study doctor's decision. These blood draws may be done at a clinic close to where patient lives if they choose.

Patient will have a bone marrow aspirate and/or biopsy between Days 14-21 (+/- 3 days) of Cycle 1 then every 1-2 cycles to check the status of the disease. Patient may have additional bone marrow aspirates and/or biopsies if their doctor thinks it is necessary.

Length of Study:

Patient may receive IPI-145 for up to 24 months if the doctor thinks it is in their best interest. Patient will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.

Patient's participation on the study will be over after the follow-up visit/call.

Follow-up Visit/Call:

Patient will have a follow-up visit 30 days after their last dose of the study drug. At this visit, patient will be asked about any side effects they may be having. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes.

This is an investigational study. IPI-145 is not FDA approved or commercially available. Its use in this study is investigational.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT02028039
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2013