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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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