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

Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndrome

Intervention: Antithymocyte globulin (Drug); Cyclosporine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Sanz Guillermo, Dr, Study Director, Affiliation: HOSPITAL LA FE VALENCIA
Julia Antonio, Dr, Study Director, Affiliation: Hospital Vall d'Hebron Barcelona

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.

Clinical Details

Official title: SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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:

- 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

Locations and Contacts

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

Additional Information

Spanish association of Haematology

Related 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.

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.

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.

Young NS. The problem of clonality in aplastic anemia: Dr Dameshek's riddle, restated. Blood. 1992 Mar 15;79(6):1385-92. Review.

Jonásova A, Neuwirtová R, Cermák J, Vozobulová V, Mociková K, Sisková M, Hochová 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.

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.

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.

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.

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.

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.

Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Löwenberg 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.

Cheson BD, Bennett JM, Kantarjian H, Schiffer CA, Nimer SD, Löwenberg 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.

Starting date: May 2002
Last updated: November 17, 2008

Page last updated: August 20, 2015

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