06.02.2003

Sayın TTR üyeleri AÜTF Hematoloji BD Hemaferezis Ünitesinde yürütülmekte olan Faz III steroide Refrakter cilt kronik GVHH’de ECP +CsA ve MP vs CsA+MP etkinliği açık etiket, tek kör, randomize çalışmanın hasta alıma ve alınamam kriterleri aşağıda sunulmuştur. Uygun hastanız olduğu zaman her türlü geliş, gidiş ve çalışma giderleri tarafımızdan karşılanmak üzere merkezimizle işbirliği yaparsanız, çok sevineceğiz. Sadece 16 merkezin katıldığı bu çok merkezli çalışmada ülkemizden verilecek hasta sayısının arttırılmasına çalışmaktayız.
Prof. Dr. Osman İlhan, Doç.Dr. Önder Arslan, Dr. Mutlu Arat
A. Inclusion Criteria

Patients must meet each of the following criteria to be eligible for enrollment into this study:
1. Histologically confirmed chronic cutaneous GvHD greater than 80 days after stem cell or marrow transplant from a related or unrelated donor.
2. Documented skin involvement on the Skin Assessment CRF (see Section V.C and Appendix B).
3. Patients identified by the investigator as likely to be unresponsive to current therapy can be entered into the steroid challenge screening phase. If the patient progresses or shows negligible or no improvement, he or she can be entered into the randomization phase of the trial.

OR

Steroid dependent patients who flare upon attempts to taper steroids. If there is documented flare upon steroid taper, the patient can be entered into the randomization phase of the trial.

OR
Patients already on the maximum tolerable dose of steroids.
4. Adequate renal, hepatic, and cardiac reserve to enable the patient to tolerate the extracorporeal volume shifts associated with ECP, as determined by the physician’s clinical judgment.
5. WBC ³ 1000/cmm and platelets ³ 25,000/mL.
6. Karnofsky Performance score ³ 30.
7. Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study.
8. Weight ³ 40 kg (88 lb).
9. Systolic blood pressure ³ 90 mm Hg.
10. Patients must be able and willing to comply with all study procedures.
11. Signed and witnessed informed consent must be obtained prior to conducting any study procedures. The parent or legal guardian of a minor must also provide written informed consent.

B. Exclusion Criteria

The presence of any of the following criteria will exclude the patient from participating in this study:
1. Hypersensitivity or allergy to psoralen (methoxsalen).
2. Hypersensitivity or allergy to both heparin and citrate products. (If hypersensitive or allergic to only one of these two products, exclusion does not apply.)
3. Participation in another clinical trial of immunosuppressive/steroid treatment for chronic GvHD within 7 days prior to screening.
4. Active gastrointestinal bleeding due to GvHD of the gut.
5. Previous treatment with ECP.
6. Females who are pregnant and/or lactating.