Spots Global Cancer Trial Database for An Open-label Phase II Study of Lorvotuzumab Mertansine

Study Description

Brief Summary: The goal of this clinical research study is to learn if lorvotuzumab mertansine can help to control blood cancers that have the CD56 tumor marker. The safety of this drug will also be studied.

Detailed Description: Study Treatment: If you are found to be eligible to take part in this study, you will receive lorvotuzumab by vein on Days 1 and 8 (+/- 2 days) of each cycle. It may take a few minutes or several hours to receive the study drug. Your doctor will discuss this with you. All treatments with IMGN901 must be administered at MD Anderson. Each cycle is 21 days (+/-6 days). However, they may be longer or shorter depending on if/how the disease responds to the treatment, how your bone marrow reacts to treatment, and what the doctor thinks is in your best interest. Your dose of lorvotuzumab may be raised, lowered, and/or delayed if the doctor thinks it is in your best interest. Study Visits: On Day 1 of each cycle, you will have a physical exam. One (1) time each week during the first 4 cycles, blood (about 1 tablespoon) will be drawn for routine tests. After Cycle 4, you will have these blood draws 1 time every 2-4 weeks. If your doctor thinks it is needed, more blood may need to be drawn. The study doctor or study staff will discuss this with you if more blood is needed. During the first cycle, all the laboratory evaluations will be done at MD Anderson. After Cycle 1, you may be able to have these blood draws performed at a local lab or clinic that is closer to your home, and the results reported to the research nurse of the study at MD Anderson. The study doctor or study staff will discuss this option with you. The results of these blood draws will be sent to the study doctor for review. On Day 21 of Cycle 1 (+/- 7 days), then every 1-3 cycles after that, you will have a bone marrow aspiration/biopsy to check the status of the disease. If the doctor thinks it is needed, these may be done more or less often, depending on your response to the study drug. You will have blood draws and/or bone marrow aspirations at any time that the doctor thinks it is needed while you are on study. If you stay on study for more than 6 months and you are not having side effects, you may have some of the above tests more or less frequently. For example, you may only have a bone marrow aspiration 1 time every 6-12 months and blood draws 1 time each cycle. The study doctor will discuss this with you. Length of Study: You may take up to 12 cycles of lorvotuzumab. If the doctor thinks it is in your best interest, you may be able to continue receiving the study drug beyond Cycle 12. 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 follow-up. End-of-Study Visit: If you leave the study before the end of Cycle 12, within 30 days (+/- 7 days) after the last dose of study drug: * Blood (about 2-3 tablespoons) will be drawn for routine tests. * If the doctor thinks it is needed, you will have a bone marrow aspirate/biopsy to check the status of the disease. Long Term Follow-Up: If the disease appears to get better and you are responding well to the study drug, you will return to MD Anderson every 3-6 months for up to 5 years after your last dose of study drug for the study staff to check how you are doing. If you cannot return to MD Anderson for these visits, you may be called by a member of the study staff. The call should last about 10 minutes. This is an investigational study. Lorvotuzumab is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the drug is designed to work. Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial