NCT00488436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2002

Longer than P75 for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

Enrollment Period

5.1 years

First QC Date

June 19, 2007

Last Update Submit

November 17, 2008

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic SyndromeAntithymocyte GlobulinCyclosporine

Outcome Measures

Primary Outcomes (1)

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

    3 years

Interventions

Antithymocyte globulinDRUG
CyclosporineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital de Cabueñes

Asturias, Spain

Location

Hospital germans Trias i Pujol

Badalona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital Ntra Sra del Rossell

Cartagena, Spain

Location

Hospital Materno Infantil de Las Palmas

Las Palmas de Gran Canaria, Spain

Location

Hospital Virgen de la Victoria

Málaga, Spain

Location

Hospital Morales Messeguer

Murcia, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

Hospital Dr Pesset

Valencia, Spain

Location

Hospital Clinico Universitario

Zaragoza, Spain

Location

Related Publications (12)

  • 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.

    PMID: 1288301BACKGROUND

  • 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.

    PMID: 9753062BACKGROUND

  • 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.

    PMID: 1830630BACKGROUND

  • 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.

    PMID: 1547338BACKGROUND

  • 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.

    PMID: 9488617BACKGROUND

  • 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.

    PMID: 11684279BACKGROUND

  • 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.

    PMID: 11739151BACKGROUND

  • 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.

    PMID: 9401087BACKGROUND

  • 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.

    PMID: 9058730BACKGROUND

  • 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.

    PMID: 6952920BACKGROUND

  • 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.

    PMID: 11090046BACKGROUND

  • 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.

    PMID: 11535540BACKGROUND

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Antilymphocyte SerumCyclosporine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptides

Study Officials

  • Sanz Guillermo, Dr

    Hospital La Fe de Valencia

    STUDY DIRECTOR

  • Julia Antonio, Dr

    Hospital Vall d'Hebron Barcelona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

May 1, 2002

Primary Completion

June 1, 2007

Study Completion

December 1, 2007

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

ES(11)