New drug shows promise in preventing transplant complication
NCT ID NCT02867384
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether the drug obinutuzumab can prevent chronic graft-versus-host disease (cGVHD), a common and serious complication after a stem cell transplant. 181 people who had a stem cell transplant took part. The goal was to see if obinutuzumab could reduce the need for steroids to treat cGVHD in the first year after transplant.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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181 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects deemed potentially eligible by their treating physicians will be screened for enrollment after d+60 from transplantation * Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation are eligible. * Peripheral blood stem cells must have been used as the stem cell source. * Patients must have received transplantation from donors (both related and unrelated) who are identical at 8 HLA loci (A, B, C and DR1), or mismatched at no more than 1 locus (7/8). Among related donors, HLA C typing is not required (6/6 HLA matches). Class I typing is to be performed by PCR-SSP techniques and CDC techniques. Class II typing is performed by PCR-RFLP +/- PCR-SSP techniques. * No evidence of relapsed or residual malignancy within 30 days of trial entry. All patients must undergo appropriate staging for their malignancy (i.e. bone marrow aspiration for the Leukemias and PET-CT scanning for the lymphomas). Evidence of a persistent Cytogenetic abnormality will constitute evidence of residual or relapsed disease in the Leukemias, where present. Individuals with CLL are eligible if there is no more than 20% residual leukemia in the bone marrow at the time of study entry. * Patients who have undergone a non-myeloablative stem cell transplant must have \> 80% donor hematopoiesis within 30 days of study enrollment. Chimerism within 30 days of study entry must be greater than, equal to, or no more than 5% less than the chimerism measured at approximately day+30 (if performed). * Age ≥ 18.0 * ECOG performance status ≤2 (Karnofsky ≥60%) (See Appendix A) * Participants must have normal marrow function as defined by: * WBC ≥ 2,500/μL * Absolute Neutrophil Count ≥ 1,000/μL * Platelets ≥ 50,000/μL * Ability to understand and the willingness to sign a written informed consent document. * The effects of Obinutuzumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Obinutuzumab administration. Exclusion Criteria: * Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow. * Allogeneic stem cell transplantation using in vivo or ex vivo T cell depletion, either by cell manipulation or with T cell depleting antibodies (Any anti-thymocyte globulin preparation or alemtuzumab given within 30 days of transplantation) * Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD. Prior completion of experimental therapy for acute GVHD is permissible if the experimental agent was used \> 30 days prior to enrollment. * Any evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD. Ongoing, tapering therapy for resolved acute GVHD is permissible. * Any evidence of prior active or resolved chronic GVHD. * History of severe allergic reaction to Obinutuzumab * No Donor Lymphocyte Infusion (DLI) prior to day 100, and no plans for a DLI in the upcoming 30 days. * Evidence of any active uncontrolled infection (bacterial, viral or fungal) or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV. Evidence of Hepatitis B exposure includes the presence of Hepatitis B surface antigenemia, a positive serological test for Hepatitis B core antibody or nucleic acid testing (NAT testing) that is positive for Hepatitis B. Vaccination to Hepatitis B is not an exclusion criteria. * Pregnancy or lactation. Negative pregnancy test is required within the screening window * Active use of any other investigational agents.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Stanford University
Palo Alto, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can a new drug regimen beat the standard for stem cell transplant complications?
- One vitamin a pill before transplant: a new shield against a deadly complication?
- A gentler transplant may cure sickle cell and thalassemia — can the body accept donor cells?
- Can a safer dose of an old drug shield vulnerable children from deadly fungal infections?
- Gene analysis may unlock secrets of bone marrow transplant complication