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Clinical Trials/EUCTR2014-002388-13-SE
EUCTR2014-002388-13-SE
Active, not recruiting
Phase 1

A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics, safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric subjects with newly diagnosed advanced myelodysplastic syndrome or juvenile myelomonocytic leukemia before hematopoietic stem cell transplantation.

Celgene Corporation0 sites55 target enrollmentMarch 9, 2015
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DrugsVidaza 25 mg/ml powder for suspension for injection

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Celgene Corporation
Enrollment
55
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 9, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient has newly diagnosed advanced primary or secondary MDS with an amount of immature cells in blood or bone marrow or chromosomal abnormality linked to secondary MDS. Blood or bone marrow samples confirming diagnosis within 14 days prior to ICF as for the MDS.
  • •1\. Patient has newly diagnosed JMML, with samples from blood and bone marrow confirming diagnosis within the 14 days prior to informed consent/informed assent signature, with specific alteration in genes (which carry the information that determines a person characteristics) in the body
  • •Both MDS and JMML:
  • •2\.Patient has a Lansky play score/ Karnofsky performance status at least equal to 60
  • •3\.Patient has a normal renal function and a normal liver function.
  • •4\.Subjects should be between 1 month to less than 18 years at time of signing ICF/ IAF
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 55
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •MDS exclusions:
  • •1\.Patient has an illness caused by 'genetic defects' (which cause abnormalities in the information that determine a person's characteristics).
  • •2\.Patient has inherited disease that cause bone marrow (the soft tissue inside of the bone) failures.
  • •JMML Exclusion:
  • •1\.Patient has a specific deviation in so called Germline.
  • •1\.Patient has any other organ dysfunction that will interfere with the administration of the therapy according to this protocol.
  • •2\.Hypersensitivity to azacitidine

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
To determine the safety, clinical efficacy, and effect of azacitidine on the body and the DNA structure in children and young adults with newly diagnosed advanced Myelodysplastic Syndromes or Juvenile myelomonocyctic leukemia before transplantation of the bone marrow and blood. At the end of the study, the data will be compared to data from an older study of patients with the same diseases.
EUCTR2014-002388-13-NLCelgene Corporation28
Active, not recruiting
Phase 1
To determine the safety, clinical efficacy, and effect of azacitidine on the body,within the body and interactions within the body in children and young adults with newly diagnosed advanced Myelodysplastic Syndromes or Juvenile myelomonocyctic leukemia before transplantation of the bone marrow and blood. At the end of the study, the data will be compared to data from an older study of patients with the same diseases.newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT)MedDRA version: 20.0 Level: LLT Classification code 10054439 Term: Juvenile chronic myelomonocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes System Organ Class: 100000004851MedDRA version: 20.1 Level: PT Classification code 10023249 Term: Juvenile chronic myelomonocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-002388-13-CZCelgene Corporation28
Active, not recruiting
Phase 1
To determine the safety, clinical efficacy, and effect of azacitidine on the body,within the body and interactions within the body in children and young adults with newly diagnosed advanced Myelodysplastic Syndromes or Juvenile myelomonocyctic leukemia before transplantation of the bone marrow and blood. At the end of the study, the data will be compared to data from an older study of patients with the same diseases.
EUCTR2014-002388-13-ATCelgene Corporation55
Active, not recruiting
Phase 1
To determine the safety, clinical efficacy, and effect of azacitidine on the body,within the body and interactions within the body in children and young adults with newly diagnosed advanced Myelodysplastic Syndromes or Juvenile myelomonocyctic leukemia before transplantation of the bone marrow and blood. At the end of the study, the data will be compared to data from an older study of patients with the same diseases.newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT)MedDRA version: 20.0 Level: LLT Classification code 10054439 Term: Juvenile chronic myelomonocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes System Organ Class: 100000004851MedDRA version: 20.1 Level: PT Classification code 10023249 Term: Juvenile chronic myelomonocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-002388-13-IECelgene Corporation55
Active, not recruiting
Not Applicable
To determine the safety, clinical efficacy, and effect of azacitidine on the body,within the body and interactions within the body in children and young adults with newly diagnosed advanced Myelodysplastic Syndromes or Juvenile myelomonocyctic leukemia before transplantation of the bone marrow and blood. At the end of the study, the data will be compared to data from an older study of patients with the same diseases.newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT)MedDRA version: 17.1Level: LLTClassification code 10054439Term: Juvenile chronic myelomonocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.1Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851MedDRA version: 17.1Level: PTClassification code 10023249Term: Juvenile chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-002388-13-ITCelgene Corporation55