Recruiting
Phase 2

Antithymocyte Globulin

Sponsor:

Office of Rare Diseases (ORD)

Code:

NCT00466843

Conditions

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antithymocyte globulin (ATG)

Prednisone

Study Details

Brief summary:

Myelodysplastic syndrome (MDS) is a rare, potentially serious bone marrow disease. Currently available treatments for MDS have been only somewhat beneficial. The purpose of this study is to determine the effects of the medication antithymocyte globulin (ATG) in adults with MDS and to determine which individuals with MDS are most likely to benefit from treatment with ATG.

Conditions

Myelodysplastic Syndrome

Study ID

NCT00466843

Start date

Apr, 2007

Status verified date

Jun, 2009

Completion date

Feb, 2010

Anticipated

Primary completion date

Feb, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of MDS that meets International Prognostic Scoring System (IPSS) criteria for low risk, intermediate-1 risk, or intermediate-2 risk. More information about this criterion can be found in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Willing and able to attend study visits
  • Willing to use acceptable forms of contraception prior to study entry and for the duration of the study

Exclusion Criteria:

  • Any serious medical illness that might limit survival to less than 2 years
  • Any other uncontrolled condition or illness. More information about this criterion can be found in the protocol.
  • Prior anti-lymphocyte serotherapy (received serum from an immunized animal)
  • Proliferative chronic myelomonocytic leukemia
  • MDS that is caused by radiotherapy, chemotherapy, and/or immunotherapy for cancerous or autoimmune diseases
  • Previous or current cancer. More information about this criterion can be found in the protocol.
  • Receiving any other investigational agents
  • Certain abnormal lab values. More information about this criterion can be found in the protocol.
  • History of a grade 2 National Cancer Institute common toxic criteria allergic reaction to rabbit proteins
  • Psychiatric illness that might interfere with study participation
  • HIV-1 infection
  • Pregnancy or breastfeeding

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Participants will be treated with ATG

Interventions

Antithymocyte globulin (ATG)

ATG 2.5 mg/kg/day via IV will be given for 4 doses. Each participant will receive only one cycle of therapy. The daily infusion will be administered over at least 6 hours and slowed as necessary to minimize infusion-related symptoms.

Prednisone

All participants will be pre-treated with prednisone (1 mg/kg/day by mouth) 2 days prior to the first ATG does and continuing for 14 days after the final dose to prevent serum sickness

Primary outcome measure

  • Bone marrow response and hematologic improvement [ Time Frame: Measured at Week 16 or 24 ]
  • Bone marrow cytogenetic response [ Time Frame: Measured at Week 16 or 24 ]

Central Contacts and Locations

Locations

H. Lee Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Tera Uliano, RN

813-745-1706

Principal Investigator:

Alan List, MD

Cleveland Clinic Foundation - Case Western University

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Robin Heggeland, RN

heggelr@ccf.org

Principal Investigator:

Jaroslaw P. Maciejewski, MD, PhD

Penn State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Lynn Ruiz

lruiz@psu.edu

Principal Investigator:

Thomas P. Loughran, Jr., MD

More Information

Sponsor

Office of Rare Diseases (ORD)

Last update posted

Jun 2, 2009

Last verified

Jun, 2009

Keywords

  • Abnormal hematopoiesis
  • Leukemia
  • Autoimmune Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Office of Rare Diseases (ORD) on 2009-06-02.