Effects of Antithymocyte Globulin in Adults With Myelodysplastic Syndrome
Mechanism and Response of Thymoglobulin in Patients With Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
54
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2007
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJune 2, 2009
June 1, 2009
2.8 years
April 25, 2007
June 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bone marrow response and hematologic improvement
Measured at Week 16 or 24
Bone marrow cytogenetic response
Measured at Week 16 or 24
Study Arms (1)
1
EXPERIMENTALParticipants will be treated with ATG
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCLA Oncology Center
Los Angeles, California, 90095, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Cleveland Clinic Foundation - Case Western University
Cleveland, Ohio, 44195, United States
Penn State University
Hershey, Pennsylvania, 17033, United States
Related Publications (4)
Kochenderfer JN, Kobayashi S, Wieder ED, Su C, Molldrem JJ. Loss of T-lymphocyte clonal dominance in patients with myelodysplastic syndrome responsive to immunosuppression. Blood. 2002 Nov 15;100(10):3639-45. doi: 10.1182/blood-2002-01-0155. Epub 2002 Jul 5.
PMID: 12393644BACKGROUNDMaciejewski JP, Rivera C, Kook H, Dunn D, Young NS. Relationship between bone marrow failure syndromes and the presence of glycophosphatidyl inositol-anchored protein-deficient clones. Br J Haematol. 2001 Dec;115(4):1015-22. doi: 10.1046/j.1365-2141.2001.03191.x.
PMID: 11843844BACKGROUNDMolldrem JJ, Leifer E, Bahceci E, Saunthararajah Y, Rivera M, Dunbar C, Liu J, Nakamura R, Young NS, Barrett AJ. Antithymocyte globulin for treatment of the bone marrow failure associated with myelodysplastic syndromes. Ann Intern Med. 2002 Aug 6;137(3):156-63. doi: 10.7326/0003-4819-137-3-200208060-00007.
PMID: 12160363BACKGROUNDKomrokji RS, Mailloux AW, Chen DT, Sekeres MA, Paquette R, Fulp WJ, Sugimori C, Paleveda-Pena J, Maciejewski JP, List AF, Epling-Burnette PK. A phase II multicenter rabbit anti-thymocyte globulin trial in patients with myelodysplastic syndromes identifying a novel model for response prediction. Haematologica. 2014 Jul;99(7):1176-83. doi: 10.3324/haematol.2012.083345. Epub 2014 Jan 31.
PMID: 24488560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan List, MD
H. Lee Moffitt Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
April 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 2, 2009
Record last verified: 2009-06