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

Primary Purpose

Myelodysplastic Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Antithymocyte globulin
Cyclosporine
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic Syndrome, Antithymocyte Globulin, Cyclosporine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Cabueñes
  • Hospital germans Trias i Pujol
  • Hospital de Basurto
  • Hospital Ntra Sra del Rossell
  • Hospital Materno Infantil de Las Palmas
  • Hospital Virgen de la Victoria
  • Hospital Morales Messeguer
  • Hospital de Navarra
  • Hospital Arnau de Vilanova
  • Hospital Dr Pesset
  • Hospital Clinico Universitario

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 19, 2007
Last Updated
November 17, 2008
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00488436
Brief Title
Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
Official Title
SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PETHEMA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic Syndrome, Antithymocyte Globulin, Cyclosporine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Antithymocyte globulin
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Primary Outcome Measure Information:
Title
Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanz Guillermo, Dr
Organizational Affiliation
HOSPITAL LA FE VALENCIA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julia Antonio, Dr
Organizational Affiliation
Hospital Vall d'Hebron Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Cabueñes
City
Asturias
Country
Spain
Facility Name
Hospital germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital Ntra Sra del Rossell
City
Cartagena
Country
Spain
Facility Name
Hospital Materno Infantil de Las Palmas
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospital Morales Messeguer
City
Murcia
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
Country
Spain
Facility Name
Hospital Dr Pesset
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
1288301
Citation
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.
Results Reference
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PubMed Identifier
9753062
Citation
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.
Results Reference
background
PubMed Identifier
1830630
Citation
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.
Results Reference
background
PubMed Identifier
1547338
Citation
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.
Results Reference
background
PubMed Identifier
9488617
Citation
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.
Results Reference
background
PubMed Identifier
11684279
Citation
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.
Results Reference
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PubMed Identifier
11739151
Citation
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.
Results Reference
background
PubMed Identifier
9401087
Citation
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.
Results Reference
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PubMed Identifier
9058730
Citation
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.
Results Reference
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PubMed Identifier
6952920
Citation
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.
Results Reference
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PubMed Identifier
11090046
Citation
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.
Results Reference
background
PubMed Identifier
11535540
Citation
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.
Results Reference
background
Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology

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

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