Rituximab for Prevention of Chronic GVHD

NCT00379587 | Completed Phase 1 Results

• 1 other identifier: 05-377
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted form one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to "reject" the body. Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them.

Conditions

Hematological Malignancies

Keywords

Rituximab; Chronic GVHD

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years

  by 1 and 2 years after peripheral blood stem cell (PBSC) infusion

Secondary Outcomes (3)

• Incidence of Grade 3 or Higher Infectious Complications

  by 1 and 2 years after peripheral blood stem cell (PBSC) infusion

• Incidence of Relapse or Progression of Disease

  by 4 years after peripheral blood stem cell (PBSC) infusion

• Incidence of Adverse Hematological Events

  by 18 months after peripheral blood stem (PBSC) infusion

Interventions

Rituximab DRUG

Rituximab at months 3, 6, 9 and 12 post-transplant

375 mg/m2 RRituximab DRUG

Rituximab 375 mg/m2 q3months

Eligibility Criteria

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

You may qualify if:

• Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation
• Peripheral blood stem cells must have been used as the stem cell source
• Patients must have received transplantation from donors who are identical at 6 HLA loci, or mismatched at no more than 1 locus.
• Patients who have undergone a non-myeloablative stem cell transplant must have \> 80% donor hematopoiesis within 30 days of study enrollment
• years of age or older
• Performance Status 0-2
• Life expectancy of \> 100 days
• Subjects with CLL are eligible, if there is no more than 20% residual leukemia in the bone marrow at the time of study entry

You may not qualify if:

• Evidence of relapsed or residual malignancy within 30 days of trial entry
• Highly aggressive B cell malignancy, such as Burkitt's lymphoma or Burkitt's-like lymphoma
• Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow
• Evidence of any active uncontrolled infection, or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV
• Evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD
• GVHD with chronic features diagnosed prior to day +100 or prior to enrollment
• Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD
• No Donor Lymphocyte Infusion (DLI) prior to day 100 and not plans for a DLI in the upcoming 30 days
• Heart failure uncontrolled by medications
• Pregnancy or lactation

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genentech, Inc.: collaborator
• Biogen: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Cutler C, Kim HT, Bindra B, Sarantopoulos S, Ho VT, Chen YB, Rosenblatt J, McDonough S, Watanaboonyongcharoen P, Armand P, Koreth J, Glotzbecker B, Alyea E, Blazar BR, Soiffer RJ, Ritz J, Antin JH. Rituximab prophylaxis prevents corticosteroid-requiring chronic GVHD after allogeneic peripheral blood stem cell transplantation: results of a phase 2 trial. Blood. 2013 Aug 22;122(8):1510-7. doi: 10.1182/blood-2013-04-495895. Epub 2013 Jul 16.

  PMID: 23861248 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Bronchiolitis Obliterans Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

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

corey_cutler@dfci.harvard.edu

617-632-5946

Study Officials

• Corey Cutler

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 22, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 19, 2014
• Results First Posted: March 19, 2014

Record last verified: 2014-02

Locations

US (1)