Phase I Study of Milatuzumab for Graft Versus Host Disease (NCT01663766) | Clinical Trial Compass
TerminatedPhase 1
Phase I Study of Milatuzumab for Graft Versus Host Disease
Stopped: PIs agreed no safety signals were shown, drug did not appear to lessen the risk of preventing GVHD no further patients would be enrolled
United States12 participantsStarted 2013-12
Plain-language summary
This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic malignancies undergoing stem cell transplant.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males or non-pregnant, non-lactating females, ≥ 18 years of age
* Able to understand and willing to sign informed consent.
* Histologically confirmed hematologic malignancy that is deemed best treated by RIC allogeneic SCT, including:
* Acute myeloid or lymphoblastic leukemia (AML, ALL) with \< 5% blasts in the bone marrow
* Myelodysplastic syndrome and intermediate-2 or high-risk IPSS score with \< 5% blasts in the bone marrow
* Chronic myelogenous leukemia failing to respond to at least two different tyrosine kinase inhibitors
* Multiple myeloma that has relapsed following autologous stem cell transplant
* Follicular lymphoma (grades 1, 2, or 3a by WHO criteria) or monocytoid lymphoma that has relapsed following at least two prior chemotherapy regimens and with either no lymph node groups ≥ 3 cm or with a ≥ 50% reduction in estimated lymph node diameter with most recent salvage therapy
* Diffuse large B-cell NHL that has relapsed after at least 2 prior chemotherapy regimens (could include high-dose chemotherapy with autologous stem cell rescue) and is still sensitive to chemotherapy by virtue of a PR or CR following most recent salvage chemotherapy
* Transformed follicular lymphoma that has achieved a PR or CR following chemotherapy
* Mantle cell lymphoma that has relapsed after at least 2 prior chemotherapy regimens (could include high-dose chemotherapy with autologous stem cell rescue)
* CLL/SLL/PLL that meets one of the following:
* del (17p13.1) i…
What they're measuring
1
All patients administered any dose of study drug will be included in the evaluation of safety
Timeframe: Safety will be assessed by measuring the change from baseline during 7 days of treatment and up to 30 days after treatment