NCT01462578

Brief Summary

Assessment of efficacy of azacitidine to prevent a relapse

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

June 22, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

6.9 years

First QC Date

June 22, 2011

Last Update Submit

November 12, 2021

Conditions

Acute Myelocytic LeukemiaMyelodysplastic Syndrome

Keywords

Neoplasms benign, malignant and unspecifiedAcute myeloid leukemiaAMLMyelodysplastic syndromeMDS

Outcome Measures

Primary Outcomes (1)

  • Number of patients with hematological relapse 6 months after start of treatment with azacitidin

    6 months after end of treatment

Secondary Outcomes (4)

  • Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD

    2 years follow-up after treatment

  • Number of patients with infectious SAEs (rate of SAE)

    2 years follow-up after treatment

  • Rate of changes of methylation in CD34+ cells

    2 years follow-up after treatment

  • Relapse-free survival and overall survival

    12, 24 and 30 months after start of treatment

Study Arms (1)

Azacytidine

EXPERIMENTAL

Azacytidine injection: 75 mg/m²/d, subcutaneous

Drug: Azacitidine

Interventions

AzacitidineDRUG

Azacytidine injection: 75 mg/m²/d, subcutaneous; initial minimum 6 cycles; another 6 or 12 cycles according to MRD niveau; maximum 24 cycles

Also known as: Vidaza®
Azacytidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening:
  • signed informed consent
  • Age ≥18 years
  • patients with MDS or AML after conventional chemotherapy or allogeneic HSCT and positive molecular marker such as t(6,9), NPM1 pos. or CD34+ or CD117+ in the case of an allogeneic HSCT
  • Treatment:
  • MDS or AML without haematological relapse (blasts \<5% in the bone marrow), and
  • decrease of CD34 donor chimerism (\<80%) after allogeneic related or unrelated HSCT in CD34+ or CD117+ MDS or AML or
  • increase in the AML-specific molecular marker in the quantitative PCR for t(6,9), NPM1+ AML \>1% after conventional chemotherapy or allogeneic HSCT or
  • persistence of the (above) MRD levels \>1% (relative to the reference gene) after conventional chemotherapy or allogeneic HSCT
  • leukocytes \> 3 Gpt/l and platelets \>75 Gpt/l (transfusion independent)

You may not qualify if:

  • Known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure,
  • addiction or other disorders that do not allow the concerned person, to assess the nature and scope and possible consequences in the clinical investigation
  • pregnant or breast feeding women
  • women of childbearing potential, except women who meet the following criteria:
  • post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH \>40 U/ml)
  • postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy )
  • regular and proper use of a contraceptive method with error rate \<1% per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD) during study treatment and up to 1 year after completion of therapy
  • sexual abstinence during study treatment and up to 1 year after completion of therapy
  • Vasectomy of the partner
  • Men who do not use one of the following types of effective contraception during study treatment and up to 1 year after completion of therapy:
  • sexual abstinence
  • State post-vasectomy
  • Condom
  • Evidence that the participating person is not expected to comply with the protocol (such as lack of cooperation)
  • Uncontrolled active infection
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Charité Campus Benjamin Franklin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Klinikum Chemnitz (Küchwald)

Chemnitz, Germany

Location

Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I

Dresden, Germany

Location

Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum)

Essen, Germany

Location

Klinikum der J. W. Goethe-Universität, Medizinische Klinik II Hämatologie / Onkologie

Frankfurt am Main, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V

Heidelberg, Germany

Location

Klinikum rechts der Isar der TU München, III. Med. Klinik und Poliklinik

München, Germany

Location

LMU München, Klinikum Großhadern, Med. Klinik III

München, Germany

Location

Universitätsklinikum Münster, Innere Medizin A - KMT-Zentrum

Münster, Germany

Location

Related Publications (2)

  • Platzbecker U, Middeke JM, Sockel K, Herbst R, Wolf D, Baldus CD, Oelschlagel U, Mutherig A, Fransecky L, Noppeney R, Bug G, Gotze KS, Kramer A, Bochtler T, Stelljes M, Groth C, Schubert A, Mende M, Stolzel F, Borkmann C, Kubasch AS, von Bonin M, Serve H, Hanel M, Duhrsen U, Schetelig J, Rollig C, Kramer M, Ehninger G, Bornhauser M, Thiede C. Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial. Lancet Oncol. 2018 Dec;19(12):1668-1679. doi: 10.1016/S1470-2045(18)30580-1. Epub 2018 Nov 12.

    PMID: 30442503RESULT

  • Platzbecker AS, Georgi JA, Middeke JM, Sockel K, Wehner R, Herbst RT, Wolf D, Baldus CD, Oelschlaegel U, Mutherig A, Fransecky L, Noppeney R, Bug G, Gotze KS, Kramer A, Bochtler T, Stelljes M, Esseling E, Stolzel F, von Bonin M, Serve H, Hanel M, Duhrsen U, Harig A, Muller-Tidow C, Schetelig J, Stasik S, Rollig C, Ehninger G, Kramer M, Schmitz M, Bornhauser M, Platzbecker U, Thiede C. Azacitidine to treat measurable residual disease in patients with MDS/AML: final long-term results of the RELAZA2 trial. Blood. 2025 Dec 8:blood.2025030816. doi: 10.1182/blood.2025030816. Online ahead of print.

    PMID: 41359791DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesNeoplasms

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Uwe Platzbecker, Prof. Dr.

    Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2011

First Posted

October 31, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2018

Study Completion

February 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

DE(11)