Status:
WITHDRAWN
Pentostatin, Cyclophosphamide Plus Rituximab (PCR) for the Therapy of Poor-Prognosis Chronic Graft-Versus-Host Disease
Lead Sponsor:
University of Rochester
Conditions:
Active Chronic Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic graft-versus-host disease (GvHD) is a severe, life threatening complication from getting a bone marrow or stem cell transplant. It is caused by certain cells from the donor that attack your ce...
Detailed Description
As above, your chronic GvHD either has not responded to, or is not expected to, respond to standard immunosuppressive treatment for chronic GvHD. These standard treatments are given in relatively low ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic GvHD requires at least one diagnostic and/or at least one distinctive manifestation. The latter must be confirmed by pertinent biopsy, laboratory tests, or radiology in the same or another organ. (See 19.11 details)
- Confirmation of active chronic GvHD is desired but may not be feasible.
- Age \>/= 18 yrs. No gender or ethnic restrictions.
- Previously untreated chronic GvHD
- Up to 15 days' of single agent therapy may be given for patients to be considered "previously-untreated", provided progression is not observed.
- Vogelsang score20 \>/= 2
- If patients progress while on prednisone \>/= 0.5 mg/kg/day (or equivalent) for treatment of acute GvHD as they develop chronic GvHD, they may be considered candidates irrespective of the Vogelsang Score.
- Prior therapy. Patients must have received prednisone \>/= 0.5 mg/kg/day plus one (or more) of the following second agents: tacrolimus, cyclosporine, sirolimus, or mycophenolate.
- All second and subsequent failures are eligible.
- Special circumstances: involvement of a "critical organ". In these cases, progressive involvement after the use of initial therapy will suffice as a eligibility criteria irrespective of the Vogelsang score.
Exclusion
- Previous history of severe adverse reaction to either study agent.
- Prior exposure alone to any of the agents in PCR is not a contraindication, Use of more than one of the agents in PCR to treat GvHD will exclude patients from entry.
- Serious active infection (especially hepatitis B or C) not responding to therapy.
- Active malignancy and/or the requirement of immunomodulation as treatment of malignancy.
- Hematologic abnormalities: WBC \<3.0 K/uL, ANC \< 1.0 K/uL, Hgb \< 8.0 g/dL, platelets \< 50.0 K/uL.
- Non-hematologic toxicities\*:
- \*Renal. Measured creatinine clearance \<35 ml/min or the concomitant need for dialysis.
- \*Pulmonary. DLCO \<40%, FEV1, 50%.
- \*Hepatic. LFT (as measured by AST, ALT, T.bili) One or all of the levels found to be \>3 x normal.
- Other. History of any significant co-morbid disease felt to make proposed therapy excessively risky.
- Psychiatric. Patients with uncompensated severe psychiatric illness that would preclude signing the necessary consent forms or being compliant.
- Compliance. Patients unlikely to adhere to study procedure and/or is unable or unwilling to return for necessary follow-up.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01001780
Start Date
August 1 2009
End Date
January 1 2011
Last Update
October 16 2013
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642