A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

NCT00350545 | Completed Results DMC

• 4 other identifiers: IRB-0494896950BMT177NCI-2011-00450
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.

Conditions

Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.

  Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse.

  6 months

Secondary Outcomes (4)

• Number of Participants With Complete and/or Partial GVHD Response

  6 months

• Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial

  1 year

• Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation

  6 and 12 Months

• Overall Survival

  6 and 12 months

Study Arms (1)

rituximab + prednisone arm

EXPERIMENTAL

Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered.

Drug: Rituximab; Drug: Prednisone; Drug: Cyclosporine A; Drug: tacrolimus

Interventions

Rituximab DRUG

375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9

Also known as: Rituxan

rituximab + prednisone arm

Prednisone DRUG

1 mg/kg; po per day with taper

Also known as: Deltasone, Liquid Pred, Meticorten, Orasone

rituximab + prednisone arm

Cyclosporine A DRUG

trough 200-300 or lower; po

Also known as: cyclosporine, Ciclosporin

rituximab + prednisone arm

tacrolimus DRUG

trough 5-10 or lower; po

Also known as: FK-506, Fujimycin

rituximab + prednisone arm

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children and adults with a new diagnosis of chronic GVHD- that requires systemic immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone any type of donor hematopoietic cell graft or conditioning regimen.
• Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors, mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other immunosuppressive medications should not be dose increased.
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
• All subjects must provide written informed consent.

You may not qualify if:

• Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.
• Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg is allowed.
• Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis, colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated with CMV disease and is responding to therapy.
• Known Hepatitis B surface Ag positive
• Active malignant disease relapse.
• Pregnancy
• Lactating
• Inability to comply with the Rituximab treatment regimen.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Rituximab; Prednisone; Cyclosporine; Tacrolimus

Condition Hierarchy (Ancestors)

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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: David B. Miklos
• Organization: Stanford University

dmiklos@stanford.edu

650 725-4959

Study Officials

• David Miklos

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sally Arai

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine (Blood and Marrow Transplantation)

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: August 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2014
• Last Updated: November 20, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)