Vaccination against childhood leukemia

Phase 1

• Conditions: Relapsed acute lymphatic leukemia; MedDRA version: 18.1Level: LLTClassification code 10000842Term: Acute lymphatic leukaemiaSystem Organ Class: 100000004864; MedDRA version: 18.1Level: LLTClassification code 10054444Term: Leukemia relapseSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-005281-29-DE
• Lead Sponsor: niversity Hospital Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-15
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•pediatric patients with ALL (T, B, pro-B, pre-B or c-ALL) = CR3 or with = 1st relapse after stem cell transplantation (SCT); hematological remission has to be reached (<5% blasts in bone marrow or detectable minimal residual disease (MRD) =5x10E-2) after salvage chemotherapy and/or subsequent SCT.
•age 1-18 years.
•Informed consent must be given by legal representatives

Are the trial subjects under 18? yes
Number of subjects for this age range: 13
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following criteria will not be included in the trial:
•Frank relapse (>5% leukemic blasts)
•Ejection fraction <25%; on echocardiography
•Creatinine-clearance <40ml/min;
•Liver function abnormalities with bilirubin >4 mg/dL and elevation of transaminases higher than 400 U/L
•Severe infection (HIV, Chronic active viral hepatitis)
•Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukencephalopathy.
•Acute GvHD grade III or IV or extensive chronic GvHD.
•Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune haemolytic anemia)
•Need for immunosuppressive drugs
•Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study
•Women during pregnancy and lactation.
•History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
•Participation in other clinical trials or observation period of competing trials.
•No leukemic blasts available for DNA extraction and cryopreservation requirements.
•Females of childbearing potential (FCBP1) that do not agree
?to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
•Males that do not agree
?to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy
? to refrain from donating semen or sperm while on and for 28 days after discontinuation from this study treatment.
•Subjects that do not agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
•All subjects that do not agree not to share medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified