Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation

NCT02867384 | Completed Phase 2 Results DMC

• 1 other identifier: 16-256
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 5

Brief Summary

This research study is studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD).

Conditions

Graft vs. Host Disease

Keywords

Graft vs. Host Disease

Outcome Measures

Primary Outcomes (1)

• Corticosteroid-Requiring Chronic Graft-Versus-Host Disease (cGVHD) Rate

  Corticosteroid-requiring cGVHD is defined as the percentage of participants who develop chronic Graft Versus Host Disease cGVHD requiring treatment with corticosteroids within the first year following Hematopoietic Cell Transplantation HCT.

  1 year

Secondary Outcomes (10)

• All Chronic Graft-Versus-Host Disease (cGVHD) Rate

  at 1 year and 2 years

• Immunosuppression-Free Survival at 1 Year (IFS1)

  1 year

• Immunosuppression-Free Survival at 2 Years (IFS2)

  2 years

• NIH Moderate-Severe Chronic Graft-Versus-Host Disease (cGVHD) Rate

  at 1 year and at 2 years

• Cumulative Incidence Of Non-Relapse Mortality (NRM)

  at 1 year and at 2 years

Study Arms (2)

Obinutuzumab

ACTIVE COMPARATOR

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

Drug: Obinutuzumab

Placebo

SHAM COMPARATOR

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

Drug: Placebo

Interventions

Obinutuzumab DRUG

B cell depletion

Also known as: Gazyva

Obinutuzumab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy or lactation. Negative pregnancy test is required within the screening window
• Active use of any other investigational agents.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Roche-Genentech: collaborator

Study Sites (5)

Stanford University

Palo Alto, California, 94305, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Corey Cutler, MD
• Organization: Dana-Farber Cancer Institute

corey_cutler@dfci.harvard.edu

6176323470

Study Officials

• Corey Cutler, MD MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 15, 2016
• Study Start: November 29, 2016
• Primary Completion: November 29, 2023
• Study Completion: November 14, 2024
• Last Updated: February 19, 2026
• Results First Posted: March 12, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)