An Expanded Access Program for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier:
NCT01026376
First received: December 3, 2009
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including both previously treated and untreated patients.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: decitabine
Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Expanded Access Program for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Farmaceutica Ltda.:

Study Start Date: June 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: decitabine
    Cycles of 15mg/m2 infusion during 3h, 3 times a day, per 3 days
    Drug: decitabine
    Cycles of 20mg/m2 infusion during 1h, once a day, per 5 days
Detailed Description:

Myelodysplastic Syndromes (MDS), which includes a diverse group of bone marrow disorders that result in ineffective production of blood cells, frequently occurs in elderly patients. Historically, the available treatments for MDS have been symptomatic and supportive, and have not been shown to be effective in producing sustained improvement in hematopoiesis (production of all types of blood cells ) or in delaying leukemic evolution (leukemia is a serious disease in which too many white blood cells are produced, causing weakness and sometimes death). This project is an open-label (all people involved know the identity of the intervention), multicenter, international single arm, Phase 3b study to provide expanded access to Decitabine for patients with myelodysplastic syndromes (MDS). The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) according some medical classifications: FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including previously treated and untreated for MDS. The secondary objectives are to evaluate the safety and tolerability of Decitabine, as well as the overall response rate according to the International Working Group (IWG) 2000 and IWG 2006 response criteria, hematologic improvement, cytogenetic response rates (evaluation based on genetic), time to acute myeloid leukemia progression or death (evaluate the length of time that passes prior to onset of leukemia progression and/or death), blood product transfusion requirements per patient (with corresponding dates to collect the number of transfusion independent days), days in the hospital (including reason for hospitalization and the ward within the hospital where the hospitalizations occur) and, optionally, quality of life assessment (EORTC QLQ C-30). 3-day cycle: Decitabine will be administered as a 15mg/m2 administered by continuous infusion over 3 hours repeated every 8 hours for 3 days. 5-day cycle: Another optional schedule could be adopted (at discretion of investigators), Decitabine at a dose of 20mg/m² administered intravenously over 1 hour, once daily for 5 consecutive days, of a 4-week cycle. Treatment may be continued as long as the patient continues to benefit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a diagnosis of MDS (de novo / primary or secondary) of all FAB subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups
  • Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2
  • Adequate hepatic and renal function as measured by the following pre-treatment laboratory criteria within 21 days of starting treatment with Decitabine (laboratory measure of liver function no more than 2.5 times the upper limit of normal, laboratory measure of total bilirubin and serum creatinine no more than 1.5 times the upper limit of normal)
  • Female patients must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study
  • Have a negative serum or urine pregnancy test at screening
  • Male subjects should be advised not father a child while on or within 2 months of completion of Decitabine therapy

Exclusion Criteria:

  • Have a diagnosis of AML (>20% bone marrow blasts) or other progressive malignant disease
  • has previously been treated with Azacitidine or Decitabine
  • Have uncontrolled heart disease or uncontrolled congestive heart failure
  • Have uncontrolled restrictive or obstructive pulmonary disease
  • Have active viral or bacterial infection
  • Have known positive serology for HIV
  • Have a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study
  • Have known hypersensitivity to any of the excipients of decitabine
  • Are pregnant or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026376

Locations
Brazil
Belo Horizonte, Brazil
Botucatu, Brazil
Brasilia, Brazil
Campinas, Brazil
Fortaleza, Brazil
Pinheiros, Brazil
Rio De Janeiro, Brazil
Sao Paulo, Brazil
São Paulol, Brazil
Hong Kong
Hong Kong, Hong Kong
Thailand
Bangkok, Thailand
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.
  More Information

No publications provided

Responsible Party: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT01026376     History of Changes
Other Study ID Numbers: CR015037, DACOGENMYE3001
Study First Received: December 3, 2009
Last Updated: April 17, 2013
Health Authority: Korea: Food and Drug Administration
Brazil: National Health Surveillance Agency

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Myelodysplastic Syndromes
Decitabine

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014