NCT01404741

Brief Summary

5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS), but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. In the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with MDS (55-70 years).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_2

Geographic Reach
1 country

17 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

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

8.8 years

First QC Date

June 30, 2011

Last Update Submit

October 26, 2023

Conditions

Myelodysplastic SyndromeChronic Myelomonocytic Leukemia

Keywords

MDSCMMLallogeneic stem cell transplantation5-azacytidine

Outcome Measures

Primary Outcomes (1)

  • overall survival

    compare to overall survival of patients who receive after 4 cycles of 5-azacytidine either allogeneic stem cell transplantation or continuous 5-azacytidine if no compatible donor is available overall 230 patients

    three years

Secondary Outcomes (7)

  • response

    three years

  • event-free survival

    three years

  • overall survival

    three years

  • impact of Comorbidity-index on outcome

    three years

  • Treatment-related mortality

    three years

  • +2 more secondary outcomes

Study Arms (2)

5-azacytidine treatment until progress

ACTIVE COMPARATOR

5-azacytidine until progress

Procedure: 5-azacytidine until progress

allogeneic stem cell transplantation

EXPERIMENTAL

after 4 cycles 5-azacytidine and if donor available: allogeneic stem cell transplantation after reduced intensity conditioning

Procedure: allogeneic stem cell transplantation

Interventions

allogeneic stem cell transplantationPROCEDURE

donor available, after 4 cycles 5-azacytidine allogeneic stem cell transplantation after reduced conditioning

allogeneic stem cell transplantation
5-azacytidine until progressPROCEDURE

if no donor available 5-azacytidine until progress or toxicities

5-azacytidine treatment until progress

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with proven de novo or therapy-related MDS / CMML (WBC \<13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts ≤ 30 % (= RAEB-t according to FAB)
  • Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza®)
  • Male or Female; Age 55 - 70 years
  • Understand and voluntarily sign an informed consent form
  • ECOG performance status of ≤ 2 at study entry
  • Adequate renal and liver function: creatinine and bilirubin \< 3 x the upper limit of normal
  • Sufficient cardiac function (ejection fraction \> 30 %)

You may not qualify if:

  • Blasts \> 30 % in bone marrow at time of diagnosis
  • Central nervous involvement
  • Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
  • Total bilirubin, SGPT or SGOT ≥ 3 times upper the normal level
  • Left ventricular ejection fraction \< 30 %
  • Creatinine clearance \< 30 ml/min
  • DLCO \< 35 % and/or receiving supplementary continuous oxygen
  • Pregnant or breastfeeding female subject
  • Patients with a life-expectancy of less than six months because of another debilitating disease
  • Serious psychiatric or psychological disorders
  • Uncontrolled invasive fungal infection at time of registration
  • Known positive for HIV or acute infectious hepatitis, type A, B or C
  • Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Charité Campus Benjamin Franklin

Berlin, Germany

Location

Uniklinikum Bonn

Bonn, Germany

Location

Universität zu Köln

Cologne, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt am Main, Germany

Location

Universitätsklinikum Göttingen

Göttingen, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Klinikum rechts der Isar

München, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Klinikum Nürnberg

Nuremberg, Germany

Location

Medizinische Universitätsklinik II

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Related Publications (1)

  • Kroger N, Sockel K, Wolschke C, Bethge W, Schlenk RF, Wolf D, Stadler M, Kobbe G, Wulf G, Bug G, Schafer-Eckart K, Scheid C, Nolte F, Kronke J, Stelljes M, Beelen D, Heinzelmann M, Haase D, Buchner H, Bleckert G, Giagounidis A, Platzbecker U. Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study). J Clin Oncol. 2021 Oct 20;39(30):3318-3327. doi: 10.1200/JCO.20.02724. Epub 2021 Jul 20.

    PMID: 34283629DERIVED

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolaus Kroeger, Prof.

    University Medical Centre Hamburg-Eppendorf, Stem-Cell-Transplantation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 28, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2020

Study Completion

July 1, 2021

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations

DE(17)