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

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ClinicalTrials.gov Identifier: NCT00350545
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sally Arai, Stanford University

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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Drug: Rituximab Drug: Prednisone Drug: Cyclosporine A Drug: tacrolimus Not Applicable

Detailed Description:
To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Study Start Date : August 2006
Actual Primary Completion Date : May 2012
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: rituximab + prednisone arm
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
375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
Other Name: Rituxan
Drug: Prednisone
1 mg/kg; po per day with taper
Other Names:
  • Deltasone
  • Liquid Pred
  • Meticorten
  • Orasone
Drug: Cyclosporine A
trough 200-300 or lower; po
Other Names:
  • cyclosporine
  • Ciclosporin
Drug: tacrolimus
trough 5-10 or lower; po
Other Names:
  • FK-506
  • Fujimycin



Primary Outcome Measures :
  1. Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. [ Time Frame: 6 months ]
    Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse.


Secondary Outcome Measures :
  1. Number of Participants With Complete and/or Partial GVHD Response [ Time Frame: 6 months ]
    To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began

  2. Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial [ Time Frame: 1 year ]
    Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began

  3. Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation [ Time Frame: 6 and 12 Months ]
    Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment.

  4. Overall Survival [ Time Frame: 6 and 12 months ]
    Overall survival at 6 and 12 months



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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350545


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: David Miklos Stanford University
Principal Investigator: Sally Arai Stanford University

Responsible Party: Sally Arai, Associate Professor of Medicine (Blood and Marrow Transplantation), Stanford University
ClinicalTrials.gov Identifier: NCT00350545     History of Changes
Other Study ID Numbers: IRB-04948
96950 ( Other Identifier: Stanford University alternate IRB Number )
BMT177 ( Other Identifier: OnCore )
NCI-2011-00450 ( Other Identifier: National Cancer Institute (NCI) )
First Posted: July 10, 2006    Key Record Dates
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available in the publication which is forthcoming.

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Rituximab
Prednisone
Tacrolimus
Cyclosporins
Cyclosporine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Immunosuppressive Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents