Phase I Study of Milatuzumab for Graft Versus Host Disease
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|ClinicalTrials.gov Identifier: NCT01663766|
Recruitment Status : Terminated (PIs agreed no safety signals were shown, drug did not appear to lessen the risk of preventing GVHD no further patients would be enrolled)
First Posted : August 13, 2012
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|GVHD (Acute or Chronic) Acute Myeloid or Lymphoblastic Leukemia (AML or ALL) Myelodysplastic Syndrome Chronic Myelogenous Leukemia (CML) Multiple Myeloma (MM) Non-Hodgekin Lymphoma (NHL-both Follicular & Diffuse Large Cell) Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia (CLL or SLL)||Drug: milatuzumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Milatuzumab (hLL1) for Prevention of Acute Graft Versus Host Disease Following Reduced-Intensity Conditioning Allogeneic Stem Cell Transplant in Patients With Hematologic Malignancies|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Milatuzumab will be added to the standard GVHD reduced intensity consitioning and prophylaxis regimen of fludarabine, busulfan, tacrolimus and low-dose methotrexate.
Milatuzumab is a humanized anti-CD74 antibody that is administered intravenously.
- All patients administered any dose of study drug will be included in the evaluation of safety [ Time Frame: Safety will be assessed by measuring the change from baseline during 7 days of treatment and up to 30 days after treatment ]Safety will be measured by physical examinations and hematology and chemistry blood tests. Cardiac safety will be done using MUGA scans or echocardiograms. These assessments will be done routinely during treatment and up to 30 days after treatment and any change from baseline will be assessed. Long term safety will be assessed every 3 months after that for up to 1 year; any change from baseline will be assessed.
- Determine the therapeutic efficacy of milatuzumab in this patient population [ Time Frame: Efficacy will be assessed 30 days after treatment. ]Acute GVHD will be assessed at days +30 and +100 by laboratory testing. Chronic GVHD assessment will be performed at days +100, +270 & +365 after stem cell transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663766
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Study Chair:||William Wegener, MD, PhD||Immunomedics, Inc.|