NCT00004208

Brief Summary

The main objective of this trial is to evaluate the efficacy and toxicity of intensive immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion dependent low and intermediate risk myelodysplastic syndrome (MDS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 21, 2000

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

6.2 years

First QC Date

January 21, 2000

Last Update Submit

March 10, 2015

Conditions

Myelodysplastic Syndromes

Keywords

refractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastsde novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Best response rate (CR + PR)

    6 months

Secondary Outcomes (4)

  • Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders

    2 and 5 years after first response

  • Overall survival

    2 and 5 years

  • Leukemia-free survival

    2 and 5 years

  • Transformation-free survival

    2 and 5 years

Study Arms (2)

Arm A: ATG + CSA

ACTIVE COMPARATOR

Treatment consists of 15 mg/kg ATG (Mérieux; horse antithymocyte globulin; i.e. 1.5 vial/10 kg of body weight/day) given over 8-12 hours for 5 consecutive days. Cyclosporine A (CSA) will be administered orally in a dose of 2.5 mg/kg bid starting day 1 and continued through day 180.

Drug: ATG + CSA

Arm B: Supportive care

OTHER

Patients randomized to this arm will be treated as outpatients.

Behavioral: Supportive care

Interventions

ATG + CSADRUG

Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)

Arm A: ATG + CSA
Supportive careBEHAVIORAL

Patients randomized to this arm will be treated as outpatients.

Arm B: Supportive care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Hypoplastic MDS, or MDS subtype RA, RAS or RAEB with ≤ 10% blasts, or RAEB with 10-20% blasts and the patient refusing or not eligible for the MDS high risk protocol (EORTC 06961) * Transfusion dependence \< 24 months or neutrophils \< 0.5 × 109/l. * ECOG/SAKK performance status ≤ 2 * Age \> 18 years * No active uncontrolled infection * No prior chemotherapy or radiotherapy * No history of heart failure, clinically relevant cardiac arrhythmia or other hemato-oncological disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Related Publications (2)

  • Passweg JR, Giagounidis AA, Simcock M, Aul C, Dobbelstein C, Stadler M, Ossenkoppele G, Hofmann WK, Schilling K, Tichelli A, Ganser A. Immunosuppressive therapy for patients with myelodysplastic syndrome: a prospective randomized multicenter phase III trial comparing antithymocyte globulin plus cyclosporine with best supportive care--SAKK 33/99. J Clin Oncol. 2011 Jan 20;29(3):303-9. doi: 10.1200/JCO.2010.31.2686. Epub 2010 Dec 13.

    PMID: 21149672RESULT

  • Passweg JR, Giagounidis A, Simcock M, et al.: Immunosuppression for patients with low and intermediate risk myelodysplastic syndrome: a prospective randomized multicenter trial comparing antithymocyte globulin + cyclosporine with best supportive care: SAKK 33/99. [Abstract] Blood 110 (11): A-1461, 2007.

    RESULT

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemia, RefractoryAnemia, Refractory, with Excess of Blasts

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jakob R. Passweg, MS

    Kantonsspital Basel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

October 1, 2006

Study Completion

October 1, 2011

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

CH(1)