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Monoclonal Antibodies

Obinutuzumab for Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Corey Cutler, MD MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year and at 2 years

Awards & highlights

Study Summary

This trial is testing a drug to see if it can prevent a long-term complication from a bone marrow transplant.

Who is the study for?

Adults over 18 who've had a stem cell transplant for blood cancer can join this trial if they're doing well post-transplant (60+ days), have no relapse, and their body is making enough blood cells. They must match their donor in certain genes, not be pregnant or breastfeeding, and agree to use birth control. People with prior chronic GVHD, active infections, recent immune-depleting treatments or participation in other cGVHD trials can't join.Check my eligibility

What is being tested?

The study tests Obinutuzumab against a placebo to prevent chronic Graft vs. Host Disease after allogeneic peripheral blood stem cell transplantation. Participants will randomly receive either the drug or placebo to see if it helps stop the condition where transplanted cells attack the patient's body.See study design

What are the potential side effects?

Obinutuzumab might cause allergic reactions, lower resistance to infections, and possibly affect fertility. Since its effects on unborn children are unknown, precautions like using contraception are required during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stem cell transplant.

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My stem cell transplant used cells from my blood.

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I had a stem cell transplant and over 80% of my blood cells come from the donor.

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I can take care of myself but might not be able to do active work.

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My transplant donor was a close match to me.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year and at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year and at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year and at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Rate Of Corticosteroid-Requiring cGVHD At One Year From HCT

Secondary outcome measures

Cumulative Incidence Of Non-Relapse Mortality And Relapse

Immunosuppression-Free Survival (IFS) Rate

Overall cGVHD Rate After HCT

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ObinutuzumabActive Control1 Intervention

Obinutuzumab or will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. Premedication with histamine blockers and acetaminophen will be provided All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials

Group II: PlaceboPlacebo Group1 Intervention

Placebo will be administered at a pre- determine dose, intravenously, at 3, 6, 9 and 12 months from transplantation. Premedication with histamine blockers and acetaminophen will be provided All subjects will undergo allogeneic stem cell transplantation according to locally approved clinical trials

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,691 Total Patients Enrolled

Roche-GenentechIndustry Sponsor

24 Previous Clinical Trials

3,504 Total Patients Enrolled

Corey Cutler, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02867384 — Phase 2

Graft-versus-Host Disease Research Study Groups: Obinutuzumab, Placebo

Graft-versus-Host Disease Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT02867384 — Phase 2

Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02867384 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell me how many different hospitals are conducting this research project?

"Currently, this trial is being conducted at 5 locations. 3 of these are in Boston, Palo Alto and Salt Lake City with 2 other undisclosed sites. If you are considering participating in this study, please choose the location nearest to you to reduce travel time and effort."

Answered by AI

How many people are signing up for this clinical trial?

"Roche-Genentech, the sponsor of this study, needs to enroll 200 eligible patients from different clinical trial sites. For example, potential enrollees could be seen at Massachusetts General Hospital in Boston or Stanford University in Palo Alto."

Answered by AI

Could you please provide some background on Obinutuzumab research?

"Currently, there are 103 ongoing studies evaluating Obinutuzumab. 18 of those active studies are in the critical third phase. Most of the research for Obinutuzumab is conducted in La Jolla, California; however, there are 486 clinical trial sites across the United States."

Answered by AI

Has Obinutuzumab been cleared by the FDA?

"Obinutuzumab falls into the Phase 2 category, which suggests that while there is some safety data available, none exists to support efficacy. Our team scored it a 2."

Answered by AI

Are people currently being recruited for this experiment?

"Yes, this information is accurate. The clinical trial in question was first posted on November 29th, 2016 and is actively recruiting participants as of June 22nd, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation

Corey S. Cutler, MD, MPH 2016. "Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02867384.

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