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NCT02221310

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

Completed Phase 2 Last updated 26 October 2023
What this trial tests

Phase 2 trial testing Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia in 25 participants. Completed in 4 April 2023.

Timeline
7 December 2011
Primary endpoint
4 April 2023
4 April 2023

Quick facts

Lead sponsorNew York Medical College
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date7 December 2011
Primary completion4 April 2023
Estimated completion4 April 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

New York Medical College

Who can join

Under 25, any sex, with Acute Myelogenous Leukemia or Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Acquired Resistance to Antibody-Drug Conjugates.
    Collins DM, Bossenmaier B, Kollmorgen G, Niederfellner G. · · 2019 · cited 109× · PMID 30897808 · DOI 10.3390/cancers11030394
  2. Current Approaches in the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.
    Ramos NR, Mo CC, Karp JE, Hourigan CS. · · 2015 · cited 91× · PMID 25932335 · DOI 10.3390/jcm4040665
  3. Natural killer cell-based immunotherapy for acute myeloid leukemia.
    Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
  4. Gemtuzumab ozogamicin and novel antibody-drug conjugates in clinical trials for acute myeloid leukemia.
    Yu B, Liu D. · · 2019 · cited 37× · PMID 31695916 · DOI 10.1186/s40364-019-0175-x
  5. Trial watch: Tumor-targeting monoclonal antibodies for oncological indications.
    Vacchelli E, Pol J, Bloy N, Eggermont A, et al · · 2015 · cited 32× · PMID 25949870 · DOI 10.4161/2162402x.2014.985940
  6. Therapeutic Antibodies for Myeloid Neoplasms-Current Developments and Future Directions.
    Schürch CM. · · 2018 · cited 30× · PMID 29868474 · DOI 10.3389/fonc.2018.00152
  7. Immunotherapeutic Concepts to Target Acute Myeloid Leukemia: Focusing on the Role of Monoclonal Antibodies, Hypomethylating Agents and the Leukemic Microenvironment.
    Gbolahan OB, Zeidan AM, Stahl M, Abu Zaid M, et al · · 2017 · cited 26× · PMID 28758974 · DOI 10.3390/ijms18081660
  8. Therapeutic Targeting of Acute Myeloid Leukemia by Gemtuzumab Ozogamicin.
    Gottardi M, Simonetti G, Sperotto A, Nappi D, et al · · 2021 · cited 16× · PMID 34572794 · DOI 10.3390/cancers13184566

Verify or expand the search:

Other trials of Gemtuzumab Ozogamicin

Trials testing the same drug.

Other recruiting trials for Acute Myelogenous Leukemia

Currently open trials in the same condition.

Other New York Medical College trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02221310.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing