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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

Must not have

Allogeneic stem cell transplantation using in vivo or ex vivo T cell depletion

Any evidence of prior active or resolved chronic GVHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year and at 2 years

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant with T cell removal.

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I have had chronic graft-versus-host disease.

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I have had a stem cell transplant using cord blood or bone marrow.

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I do not have severe skin or liver issues from a recent transplant.

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I do not have any active infections or a history of Hepatitis B, C, or HIV.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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 / 11Eligibility criteria met