Receptor for Hyaluronan-Mediated Motility (RHAMM [CD168]) peptide vaccination for patients with haematological malignancies: a phaseI/II pilot study

niversity Hospital Ulm (Universitatsklinikum Ulm) (Germany)0 个研究点目标入组 10 人开始时间: 2007年10月31日最近更新: 2019年6月17日

适应症

试验速览

•1. Diagnosis of Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM)
•2. AML: up to 25% blasts in the Bone Marrow (BM); MDS: up to 20% blasts in the BM; MM: partial remission (immunofixation still positive or immunoglobulins still detectable in the urine)
•3. Human Leukocyte Antigen A2 (HLA-A2) expression
•4. RHAMM-messenger Ribonucleic Acid (mRNA) expression
•5. Karnofsky Index greater than or equal to 70 or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
•6. Aged greater than 18 years
•7. At least one cycle of treatment with standard chemotherapy for this haematological malignancy preceding the peptide vaccination
•8. Survival time at least 6 months
•9. Sufficient renal function (creatinine and Blood Urea Nitrogen [BUN] less than threefold of the upper limit)
•10. Sufficient liver function tests (Serum Glutamic Oxaloacetic Transaminase [SGOT]/Serum Glutamic Pyruvic Transaminase [SGPT] threefold of the upper limit)
•11. Compliance of the patient
•12. Informed consent must be obtained in written form

•1. Allogeneic hematopoietic stem cell transplantation in the history planned
•2. Central Nervous System (CNS) involvment, severe psychiatric disease
•3. Severe partial or global respiratory failure (New York Heart Association [NYHA] stage greater than or equal to III)
•4. Immunosuppressive therapy in the last 4 weeks
•5. Pregnancy or breastfeeding
•6. Females with no sufficient contraception
•7. Contradictions against study therapeuticals (including galenic substances)
•8. Severe infections
•9. Simultaneous participation in another clinical study trial

发起方

niversity Hospital Ulm (Universitatsklinikum Ulm) (Germany)