AzTrials
AzTrials

Acute Myelocytic LeukemiaPhase 2RELAZA2NCT01462578

Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)

A Phase 2 study testing Azacitidine in people with Acute Myelocytic Leukemia and Myelodysplastic Syndrome, run by Technische Universität Dresden at 11 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Assessment of efficacy of azacitidine to prevent a relapse Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
11 sitesGermany
Study dates
Sep 2011to Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • Known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure,
  • Participation of the patient in another clinical trial within the last 4 weeks before the inclusion
  • 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)
Show all 19Show fewer
  • 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
  • Severe hepatic impairment (AST and ALT may not exceed three times the normal) or liver cirrhosis or malignant liver tumor
  • Dialysis dependent renal dysfunction
  • Known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease These criteria are not for the screening phase up to a known allergic reaction to azacitidine or intolerance to apply.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Charité Campus Benjamin Franklin

    Berlin

  • Universitätsklinikum Bonn

    Bonn

  • Klinikum Chemnitz (Küchwald)

    Chemnitz

  • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I

    Dresden

  • Universitätsklinikum Essen, Klinik für Hämatologie (Westdeutsches Tumorzentrum)

    Essen

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

    Frankfurt am Main

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V

    Heidelberg

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

    München

  • LMU München, Klinikum Großhadern, Med. Klinik III

    München

  • Universitätsklinikum Münster, Innere Medizin A - KMT-Zentrum

    Münster

Other trials in Germany

About this study

Official title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)

Assessment of efficacy of azacitidine to prevent a relapse

Read the detailed description

Analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a hematological relapse in MDS or AML patients with significant residuals or an increase of minimal residual disease (MRD) which is defined as:

  • 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 markers in the quantitative PCR for t(6,9), NPM1+ AML >1% (ratio to reference gene) after conventional chemotherapy or allogeneic HSCT or
  • persistence of the (above) MRD level >1% after conventional chemotherapy or allogeneic HSCT
  • tolerance of azacitidine
  • quality of the response of the MRD (major vs. minor) and the relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine
  • modulation of CD34+, NK- and T-cells of MDS and AML patients by azacitidine
Being tested
Azacitidine
Keywords
Neoplasms benign, malignant and unspecified, Acute myeloid leukemia, AML, Myelodysplastic syndrome, MDS
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Also called Vidaza®

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

Study groups in NCT01462578
Study groupRoleWhat they receive
AzacytidineExperimentalAzacytidine injection: 75 mg/m²/d, subcutaneous
Receives: Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months after end of treatment

Secondary outcomes (4)

  1. Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD

    Measured: 2 years follow-up after treatment

  2. Number of patients with infectious SAEs (rate of SAE)

    Measured: 2 years follow-up after treatment

  3. Rate of changes of methylation in CD34+ cells

    Measured: 2 years follow-up after treatment

  4. Relapse-free survival and overall survival

    Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment

    Measured: 12, 24 and 30 months after start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionAug 2018
  4. Study completionFeb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01462578
Sponsor's protocol ID
TUD-RELA02-048
Other IDs
2010-022388-37, VZ-MDS-PI-0245
Acronym
RELAZA2
Status last verified
Nov 2021
First submitted
22 Jun 2011
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30442503

  • Platzbecker AS, Georgi JA, Middeke JM, Sockel K, Wehner R, Herbst R, Wolf D, Baldus CD, Oelschlagel 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. 2026 Mar 5;147(10):1098-1110. doi: 10.1182/blood.2025030816.

    PubMed 41359791

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine in people with Acute Myelocytic Leukemia and Myelodysplastic Syndrome, run by Technische Universität Dresden at 11 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with hematological relapse 6 months after start of treatment with azacitidin (time frame: 6 months after end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01462578, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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