Clinical trial · Interventional
Effects of Antithymocyte Globulin in Adults With Myelodysplastic Syndrome
Mechanism and Response of Thymoglobulin in Patients With Myelodysplastic Syndrome (MDS)
NCT00466843CI-TRIAL-00002348unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antithymocyte globulin (ATG) | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Participants will be treated with ATG
- interventionNames
- Drug: Antithymocyte globulin (ATG)
- Drug: Prednisone
Primary outcomes (2)
- measure
- Bone marrow response and hematologic improvement
- timeFrame
- Measured at Week 16 or 24
- measure
- Bone marrow cytogenetic response
- timeFrame
- Measured at Week 16 or 24
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDKochenderfer 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 12393644
- BACKGROUNDMaciejewski 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 11843844
- BACKGROUNDMolldrem 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 12160363
- DERIVEDKomrokji 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 24488560