Phase I Study of Milatuzumab for Graft Versus Host Disease
|ClinicalTrials.gov Identifier: NCT01663766|
Recruitment Status : Unknown
Verified March 2015 by Immunomedics, Inc..
Recruitment status was: Active, not recruiting
First Posted : August 13, 2012
Last Update Posted : March 3, 2015
|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)|
|Estimated Enrollment :||40 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|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2017|
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.
- 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.
- Efficacy [ 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.
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.|