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

Phase 1

Completed

• Conditions: Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM); Cancer; Haematological malignancies

• Registration Number: ISRCTN32763606
• Lead Sponsor: niversity Hospital Ulm (Universitatsklinikum Ulm) (Germany)

Brief Summary

2008 results in: https://www.ncbi.nlm.nih.gov/pubmed/17978170 (added 34/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Study Completion: 2008-02-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified