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CompletedNCT00488436Updated Nov 19, 2008

Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

A Phase 4 interventional study of Antithymocyte globulin and Cyclosporine in Myelodysplastic Syndrome, sponsored by PETHEMA Foundation. Completed at 11 sites in Spain. Per ClinicalTrials.gov, last updated 2008-11-19.

Sponsored by PETHEMA Foundation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Sex
All
01

Study summary

The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.

Read the detailed description

Patients are treated with:

Antithymocyte globulin (Timoglobulin SangStat)

  • 2,5 mg/kg/day IV over 8 hours on days 1-4
  • Total dose: 10 mg/kg
  • Calculated dose adjusted to ideal weight
  • Especial considerations:

Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30 minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if platelet count is \< 50 x 109/L

Cyclosporine (Sandimmun Neoral)

-2,5 mg/kg/12 h over 3 months

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Conditions studied

  • Myelodysplastic Syndrome

Keywords

  • Myelodysplastic Syndrome
  • Antithymocyte Globulin
  • Cyclosporine
03

In context

Preleukemia

1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.

This study's planned enrollment of 25 is below the median of 36 across 1,060 interventional studies indexed under Preleukemia.

Browse Preleukemia studies →

Lead sponsor

PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia
  • At less one of two following conditions:
  • Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time
  • Infection grade III or IV secondary to neutropenia
  • ECOG \< or = 2

Exclusion criteria

Exclusion Criteria:

  • Chronic myelomonocytic leukemia
  • Creatinine greater than 2 mg/dl
  • Bilirubin greater than 2.5 mg/dl
  • History of heart failure
  • History of allergy to rabbit proteins
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Interventions

  • DrugAntithymocyte globulin
  • DrugCyclosporine
06

What researchers measure

Primary outcomes

  1. Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome

    Time frame: 3 years

07

Study locations

11 sites
  • Hospital de Cabueñes
    Asturias, Spain
  • Hospital germans Trias i Pujol
    Badalona, Spain
  • Hospital de Basurto
    Bilbao, Spain
  • Hospital Ntra Sra del Rossell
    Cartagena, Spain
  • Hospital Materno Infantil de Las Palmas
    Las Palmas de Gran Canaria, Spain
  • Hospital Virgen de la Victoria
    Malaga, Spain
  • Hospital Morales Messeguer
    Murcia, Spain
  • Hospital de Navarra
    Pamplona, Spain
  • Hospital Arnau de Vilanova
    Valencia, Spain
  • Hospital Dr Pesset
    Valencia, Spain
  • Hospital Clinico Universitario
    Zaragoza, Spain
08

References and documents

Publications

  • Sugawara T, Endo K, Shishido T, Sato A, Kameoka J, Fukuhara O, Yoshinaga K, Miura A. T cell-mediated inhibition of erythropoiesis in myelodysplastic syndromes. Am J Hematol. 1992 Dec;41(4):304-5. doi: 10.1002/ajh.2830410425. No abstract available. PubMed 1288301 ↗
  • Molldrem JJ, Jiang YZ, Stetler-Stevenson M, Mavroudis D, Hensel N, Barrett AJ. Haematological response of patients with myelodysplastic syndrome to antithymocyte globulin is associated with a loss of lymphocyte-mediated inhibition of CFU-GM and alterations in T-cell receptor Vbeta profiles. Br J Haematol. 1998 Sep;102(5):1314-22. doi: 10.1046/j.1365-2141.1998.00920.x. PubMed 9753062 ↗
  • Smith MA, Smith JG. The occurrence subtype and significance of haemopoietic inhibitory T cells (HIT cells) in myelodysplasia: an in vitro study. Leuk Res. 1991;15(7):597-601. doi: 10.1016/0145-2126(91)90028-r. PubMed 1830630 ↗
  • Young NS. The problem of clonality in aplastic anemia: Dr Dameshek's riddle, restated. Blood. 1992 Mar 15;79(6):1385-92. No abstract available. PubMed 1547338 ↗
  • Jonasova A, Neuwirtova R, Cermak J, Vozobulova V, Mocikova K, Siskova M, Hochova I. Cyclosporin A therapy in hypoplastic MDS patients and certain refractory anaemias without hypoplastic bone marrow. Br J Haematol. 1998 Feb;100(2):304-9. doi: 10.1046/j.1365-2141.1998.00551.x. PubMed 9488617 ↗
  • Epperson DE, Nakamura R, Saunthararajah Y, Melenhorst J, Barrett AJ. Oligoclonal T cell expansion in myelodysplastic syndrome: evidence for an autoimmune process. Leuk Res. 2001 Dec;25(12):1075-83. doi: 10.1016/s0145-2126(01)00083-2. PubMed 11684279 ↗
  • Maciejewski JP, Follmann D, Nakamura R, Saunthararajah Y, Rivera CE, Simonis T, Brown KE, Barrett JA, Young NS. Increased frequency of HLA-DR2 in patients with paroxysmal nocturnal hemoglobinuria and the PNH/aplastic anemia syndrome. Blood. 2001 Dec 15;98(13):3513-9. doi: 10.1182/blood.v98.13.3513. PubMed 11739151 ↗
  • Molldrem JJ, Caples M, Mavroudis D, Plante M, Young NS, Barrett AJ. Antithymocyte globulin for patients with myelodysplastic syndrome. Br J Haematol. 1997 Dec;99(3):699-705. doi: 10.1046/j.1365-2141.1997.4423249.x. PubMed 9401087 ↗
  • Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88. Erratum In: Blood 1998 Feb 1;91(3):1100. PubMed 9058730 ↗
  • Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99. PubMed 6952920 ↗
  • Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL; World Health Organization(WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-4. PubMed 11090046 ↗
  • Cheson BD, Bennett JM, Kantarjian H, Schiffer CA, Nimer SD, Lowenberg B, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Greenberg PL. Myelodysplastic syndromes standardized response criteria: further definition. Blood. 2001 Sep 15;98(6):1985. doi: 10.1182/blood.v98.6.1985. No abstract available. PubMed 11535540 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00488436
Lead sponsor
PETHEMA Foundation
First posted
Jun 20, 2007
Start date
May 2002
Primary completion
Jun 2007
Completion
Dec 2007
Last update
Nov 19, 2008

Study contacts

Sanz Guillermo, Dr
study director · HOSPITAL LA FE VALENCIA
Julia Antonio, Dr
study director · Hospital Vall d'Hebron Barcelona

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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