Status:
TERMINATED
Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Hemophilia A
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the rate of response when administering rituximab to suppress or eliminate the anti-body in a patient's blood that inhibits the effectiveness of their factor r...
Detailed Description
This is a prospective Phase II randomized multi-institutional controlled pilot trial comparing the regimen of single agent rituximab with 6 weeks cytotoxic therapy with oral cyclophosphamide to eradic...
Eligibility Criteria
Inclusion
- Diagnosis of acquired hemophilia A in a previously non-coagulopathic individual.
- Prior treatment with at least 3 weeks of immunosuppressive therapy
- Factor VIII: C levels \<50% within 14 days prior to study entry, which do not correct in coagulation assays in which normal plasma is mixed and incubated with patient plasma.
- Measurable anti-factor VIII:C antibody inhibitor activity \> 0.6 Bethesda Units/ml.
- Age ³18 years
- Written informed consent
- Use of an effective means to avoid pregnancy, including abstinence, for women of childbearing potential,.
- Serum bilirubin less than or equal to the upper limit of normal (ULN); ALT and AST £2.5´ ULN within 14 days prior to study entry
- Serum creatinine £1.5´ the ULN within 14 days prior to study entry
- Negative serum pregnancy test, for all women of childbearing potential, within 14 days prior to study entry
Exclusion
- Continued treatment requirement of prednisone ≥30mg/day or equivalent dosing of other corticosteroid preparations to control serious symptoms of an underlying autoimmune disease state.
- Treatment with cyclophosphamide, danazol, vinca alkaloids, azathioprine, IVIG, or other immunosuppressive, immunomodulatory, or cytotoxic agents (other than decreasing doses of corticosteroids) within 30 days prior to study entry.
- Anticipated need for repeated extracorporeal plasmapheresis in order to reverse refractory bleeding associated with acquired hemophilia.
- Treatment with other experimental agents within 30 days prior to study entry
- Known sensitivity to murine or chimeric products
- Hepatitis BsAg positivity or high risk for reactivation of Hepatitis B.
- Active infection requiring antibiotic therapy within 7 days prior to study entry
- Current use of any required medications, which in the opinion of the treating physician, could be inducing the formation of auto-FVIII:C inhibitory antibodies
- Prior treatment with rituximab or other monoclonal antibody therapy
- Known HIV antibody positivity
- NCI-CTC Grade ³1 cardiac arrhythmia ( refer to CTC v3)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Currently pregnant women, lactating women, or women within 12 months of delivery, spontaneous miscarriage, or therapeutic or elective termination of pregnancy.
- Known severe leucopenia (absolute neutrophil count \<1000/µL) or thrombocytopenia (\<25,000/µL);
- Known pre-existing cystitis or severe urinary outflow obstruction.
- Known history of recurrent severe opportunistic infections, eg. generalized herpes zoster;
- Inability or unwillingness to comply with study design and requirements and follow-up procedures.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00306670
Start Date
April 1 2006
End Date
August 1 2011
Last Update
February 10 2017
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