GVHD (Acute or Chronic)Phase 1NCT01663766
Phase I Study of Milatuzumab for Graft Versus Host Disease
A Phase 1 study testing milatuzumab in people with GVHD (Acute or Chronic) and Acute Myeloid or Lymphoblastic Leukemia (AML or ALL), run by Gilead Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GVHD (Acute or Chronic), Acute Myeloid or Lymphoblastic Leukemia (AML or ALL), Myelodysplastic Syndrome
- What is being tested?
- milatuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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) in first remission
- Response no better than a PR with chemoimmunotherapy or relapse within 2 years of chemoimmunotherapy
- Richter's transformation
- Complex karyotype
- At least 4 weeks beyond prior chemotherapy (excluding steroids), antibody therapy, radiation, or radioimmunoconjugate therapy, and with any kinase inhibitors discontinued at least one week prior to starting the conditioning regimen.
- ECOG performance status ≤ 2
- Life expectancy of greater than 3 months
- Adequate organ function measured by the following within seven days of beginning conditioning:
- AST (SGOT) ≤ 3.0 x institutional upper limit of normal (IULN)
- Total bilirubin ≤ 1.5 xIULN unless due to Gilbert's disease
- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
- DLCO > 40% with no symptomatic pulmonary disease
- LVEF by echocardiogram or MUGA of at least 30%
- Women of child bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
- Matched (8/8) related or matched unrelated donor identified. Haploidentical or umbilical cord grafts are not allowed.
- Donor willing to donate peripheral blood stem cells and meets institutional criteria for stem cell donation.
Who cannot join
- Prior allogeneic stem cell transplant
- Patients requiring a myeloablative conditioning regimen
- Patients best served by a bone marrow transplant are not eligible as this study will be restricted only to peripheral stem cells.
- No suitable donor identified
- Prior anaphylactic response or Grade 4 infusion reaction to milatuzumab
- Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Patients with active hepatitis B infection are not eligible. Patients with a history of hepatitis B (surface antigen or core antibody positive) must take lamivudine or equivalent during study therapy and for one year after completion of milatuzumab.
- LVEF < 30%
- Seropositivity for HIV or Hepatitis C
- Patients with known CNS lymphoma are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Active secondary malignancies with the exception of non-melanomatous skin cancers or low risk prostate cancer under observation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
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
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.
- Conditions
- 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)
- Being tested
- milatuzumab
- Keywords
- 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)
- Medical subject headings
- Graft vs Host Disease, Bronchiolitis Obliterans Syndrome, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milatuzumabDrug
Also called IMMU-115, hLL1, anti-CD74
Milatuzumab is a humanized anti-CD74 antibody that is administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Milatuzumab | Experimental | Milatuzumab will be added to the standard GVHD reduced intensity consitioning and prophylaxis regimen of fludarabine, busulfan, tacrolimus and low-dose methotrexate. Receives: Drug: milatuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
All patients administered any dose of study drug will be included in the evaluation of safety
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.
Measured: Safety will be assessed by measuring the change from baseline during 7 days of treatment and up to 30 days after treatment
Secondary outcomes (1)
Determine the therapeutic efficacy of milatuzumab in this patient population
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.
Measured: Efficacy will be assessed 30 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD (Acute or Chronic)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
- Investigators
- William Wegener, MD, PhD, Study chair, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663766
- Sponsor's protocol ID
- IM-T-IMMU-115-03
- Status last verified
- Sep 2020
- First submitted
- 7 Aug 2012
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01663766
- Acronym / sponsor ID
- IM-T-IMMU-115-03
- Conditions
- 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)
- Keywords
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University
- Study start
- Dec 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milatuzumab | Experimental | Drug: milatuzumabMilatuzumab will be added to the standard GVHD reduced intensity consitioning and prophylaxis regimen of fludarabine, busulfan, tacrolimus and low-dose methotrexate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (11 listed)
- Prior allogeneic stem cell transplant
- Patients requiring a myeloablative conditioning regimen
- Patients best served by a bone marrow transplant are not eligible as this study will be restricted only to peripheral stem cells.
- No suitable donor identified
- Prior anaphylactic response or Grade 4 infusion reaction to milatuzumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milatuzumabAlso: IMMU-115, hLL1, anti-CD74Milatuzumab is a humanized anti-CD74 antibody that is administered intravenously. | Drug | Milatuzumab |
Primary outcome
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.
1 secondary outcome
Determine the therapeutic efficacy of milatuzumab in this patient population
Time frame: Efficacy will be assessed 30 days after treatment.
Results and safety
The study was stopped early (reason given: PIs agreed no safety signals were shown, drug did not appear to lessen the risk of preventing GVHD no further patients would be enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Related trials for GVHD (Acute or Chronic)
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GVHD (Acute or Chronic)
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TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT
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Active, not recruitingObservational study
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
Acute Graft-versus-host Disease, Acute GVHD
RecruitingPhase 1
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Hematologic Malignancy, GvHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Wegener, MD, PhD study chair
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing milatuzumab in people with GVHD (Acute or Chronic) and Acute Myeloid or Lymphoblastic Leukemia (AML or ALL), run by Gilead Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PIs agreed no safety signals were shown, drug did not appear to lessen the risk of preventing GVHD no further patients would be enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.