deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT02992860

Single Agent JNJ-56022473 in MDS and AML Patients FAILING HYPOMETHYLATING AGENT BASED THERAPY (SAMBA)

Single Agent JNJ-56022473 in MDS and AML Patients Failing Hypomethylating Agent Based Therapy

Sponsor: GWT-TUD GmbH

Conditions Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS)
Interventions Automated CBC Bone marrow analyses and CBC with differential Central biobanking Cytogenetic analysis Flow cytometry analyses Histopathology analysis JNJ-56022473 Pregnancy Test Serum chemistry
Updated 10 times since 2017 Last updated: Oct 23, 2018 Started: Jul 31, 2016 Primary completion: Oct 31, 2018 Completion: Oct 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Enrollement was stopped due to a recommendation by the IDMC/FDA for a parallel clinical trial with TALA, where potentielly no efficancy could be determined.

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This PHASE2 trial investigates Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) and is currently terminated or withdrawn. GWT-TUD GmbH leads this study, which shows 10 recorded versions since 2016 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Oct 2017 · 9 months · monthly snapshotRecruiting~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotSuspended~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotSuspended~Nov 2018 – ~Nov 2020 · 24 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

10 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

▶ Show 5 earlier versions

  1. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2

  2. Nov 2018 — Nov 2020 [monthly]

    Terminated PHASE2

    Status: Suspended → Terminated

  3. Jun 2018 — Nov 2018 [monthly]

    Suspended PHASE2

  4. Oct 2017 — Jun 2018 [monthly]

    Suspended PHASE2

    Status: Recruiting → Suspended

  5. Jan 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jul 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GWT-TUD GmbH
Data source: GWT-TUD GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations