Clinical Trial: An Open-label Phase II Study of Lorvotuzumab Mertansine

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Open-label Phase II Study of Lorvotuzumab Mertansine (IMGN901) in CD56 Expressing Hematological Malignancies

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 Summary:

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.

  • Overall Response Rate (ORR) of IMGN901 in Participants CD56 Expressing Hematological Malignancies [ Time Frame: 53 days ]
    ORR, defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 cycles of therapy with IMGN901.
  • Overall Response Rate (ORR) of IMGN901 in Participants with Myelofibrosis [ Time Frame: 53 days ]
    ORR defined as a 50% shrinkage in spleen size on manual palpation (or 35% shrinkage in spleen size on imaging examination) and/or a 50% reduction in the total symptom score within 3 cycles of IMGN901 therapy.
  • Overall Response Rate (ORR) of IMGN901 in Participants with Blastic Plasmacytoid Dendritic Cell Neoplasm [ Time Frame: 53 days ]
    ORR, defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 cycles of therapy with IMGN901.


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: April 15, 2015
    Date Started: May 2015
    Date Completion:
    Last Updated: August 3, 2016
    Last Verified: August 2016