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

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00488436

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.3

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: Antithymocyte globulin Drug: Cyclosporine	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Hospital de Cabueñes	Asturias	Spain
2	Hospital germans Trias i Pujol	Badalona	Spain
3	Hospital de Basurto	Bilbao	Spain
4	Hospital Ntra Sra del Rossell	Cartagena	Spain
5	Hospital Materno Infantil de Las Palmas	Las Palmas de Gran Canaria	Spain
6	Hospital Virgen de la Victoria	Malaga	Spain
7	Hospital Morales Messeguer	Murcia	Spain
8	Hospital de Navarra	Pamplona	Spain
9	Hospital Arnau de Vilanova	Valencia	Spain
10	Hospital Dr Pesset	Valencia	Spain
11	Hospital Clinico Universitario	Zaragoza	Spain