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Study Summary
No. 2005-1022:.......Blood And Marrow Transplantation......Amin Alousi......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2005-1022
Study Title:A Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination with Corticosteroids for the Initial Treatment of Acute Graft-versus-Host Disease (GVHD)
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Physician New Patient Referral
Name:Amin AlousiPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
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General Information
Disease Group:Blood And Marrow TransplantationSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
For each photopheresis procedure.
Treatment
Agents:
Extracorporeal PhotopheresisHome Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find out whether adding
extracorporeal photopheresis (ECP) to standard therapy for acute GVHD with
corticosteroids improves response to treatment, length of treatment, and
survival.
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Study Objectives / Outcomes
    Primary Objective
    -To assess the efficacy of photopheresis (extracoporeal photochemotherapy or ECP) in combination with methylprednisolone for the up-front treatment of acute graft-versus-host disease (GvHD) compared with methylprednisone alone.

    Secondary Objectives
    -To assess the safety of the combination of corticosteroids with ECP
-To assess the 6 months survival of these patients.
-To assess the steroid sparing effect of photopheresis.
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Study Status Information
Study Activation / Registration Date:01/23/2008
IRB Review and Approval Date:08/21/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must be recipients of allogeneic bone marrow or stem cell grafts.

2) Patient must weigh above 40 kg

3) Patients must have new onset, clinical grade II-III acute or late-acute GVHD of the GI tract or liver, or the skin that developed post transplantation. The diagnosis of GVHD must be pathologically confirmed in at least one organ or highly suspected clinically. Pathological confirmation may occur after registration and after the start of therapy. Definition of Late Acute GVHD vs Acute GVHD: The diagnosis of Late Acute GVHD includes clinical features that are identical to Acute GVHD, however, Late Acute GVHD is diagnosed on or after day 100 post transplantation.

4) Continued from #3: These manifestations include a macularpapular rash, abnormal liver studies (cholestatic jaundice) and/or nausea/vomiting / diarrhea. Patients must not have any concurrent classical features of chronic GVHD in addition to the above manifestations. Features of chronic GVHD include dry eyes and mouth, contractures, and/ or sclerodermal, lichenoid skin changes.

5) In the clinical judgment of the PI, patients must be able to sustain a platelet count and a hematocrit >/= 20,000/mL and >/= 27% respectively, with or without transfusions.

6) The absolute WBC must be >1500/mL

7) Patient must be willing to comply with all study procedures.

8) All patients with childbearing potential, including males and females, must commit to using adequate contraceptive precautions throughout their participation in the study and for 3 months following the last ECP treatment.

Exclusion Criteria:1) Patients developing chronic GVHD following immune modulation with immunosuppression withdrawal or donor lymphocyte infusion (DLI).

2) Any clinical Manifestation consistent with de novo chronic GVHD or overlapped syndrome of acute and chronic GVHD.

3) Patients who are unable to tolerate the volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome.

4) Active bleeding

5) International normalized ration (INR) >2

6) Patients cannot have received methylprednisolone > 2mg/kg/day for more than 72 hours prior to registration.

7) Patients cannot have received any other immunosuppression for treatment of GVHD but calcineurin inhibitors and corticosteroids. Patients are allowed to have had any GVHD prophylaxis with the exception of ECP

8) Patients with known hypersensitivity or allergy to psoralen

9) Patients with known hypersensitivity or allergy to both citrate and heparin

10) Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.

11) Uncontrolled, persistent hypertriglyceridemia, with levels > 800 mg%

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Links
Registration Number: NCT00609609
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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