Chronic myelomonocytic leukemia
Conditions
Interventions
Trade Name: Ceplene
Product Name: Ceplene
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Histamin dihydrochloride
Other descriptive name: HISTAMINE DIHYDROCHLORIDE
Concentration unit
Sponsors
Nordic MDS study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • =18 years of age at the time of signing the informed consent form. • CMML-1 with indication for treatment according to NMDSG guidelines*. • Life expectancy of more than three months and ability to undergo routine outpatient evaluations for efficacy, safety, and compliance. • Informed consent obtained and signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Acute myeloid leukemia. • CMML-2 according to WHO criteria. • Systemic mastocytosis. • Previous or intended allogeneic stem cell transplantation. • Concomitant or intended cytostatic or cytoreductive therapy other than hydroxyurea (HU) *. • ECOG performance status =3. • Platelet count (TPK) 1.5 times the upper normal limit. • Serum aminotransferase (AST), alanine transaminase (ALT) and bilirubin >2.0 times the upper normal limit • Active autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis). • Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history or bleeding. • Patients requiring active treatment for hypotension. • Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents. • Patients with a history of histamine hypersensitivity, severe allergies to food or contrast media requiring treatment within the last five years. • Pregnancy. Women of childbearing potential (WCBP) and males having intercourse with WCBP must agree to comply with using an effective contraceptive method for the duration of the treatment (WCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months). • Nursing * Note that treatment with HU is allowed if treatment has been ongoing for at least 3 months prior to enrollment. The use of HU is also allowed to control myeloproliferation after starting study treatment, preferably during resting periods Please refer to section 9.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and feasibility of treatment with HDC/IL-2 in CMML;Secondary Objective: To evaluate the clinical efficacy of HDC/IL-2 treatment in CMML. To investigate the immunological effects of HDC/IL-2 in CMML;Primary end point(s): • Adverse events as defined by CTCAE v4.03.;Timepoint(s) of evaluation of this end point: Continuously from starting treatment until 30 days after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Clinical response and hematological improvement, and durations thereof, according to IWG criteria for MDS/MPN • Changes in size, genotype and phenotype of the malignant populations. • Correlation between genetic aberrations and clinical response. • The quantitative and qualitative effects of HDC/IL-2 on immune cell phenotypes and function. • Disease progression according to IWG criteria for MDS/MPN(1). • Transformation to AML. • Allo-SCT. • Survival.;Timepoint(s) of evaluation of this end point: Safety endpoints will be assessed continuously from starting treatment until 30 days after end of treatment. Efficacy and immunological endpoints will be evaluated after 4 and 10 treatment cycles. | — |
Countries
Sweden
Contacts
Public ContactClinical trials office
Sahlgrenska University Hospital
Outcome results
None listed