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NCT02221310
Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS
Phase 2 trial testing Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia in 25 participants. Completed in 4 April 2023.
4 April 2023
Quick facts
| Lead sponsor | New York Medical College |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 7 December 2011 |
| Primary completion | 4 April 2023 |
| Estimated completion | 4 April 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gemtuzumab Ozogamicin (Gemtuzumab Ozogamicin) — full drug profile →
Conditions studied
- Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
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):
-
Acquired Resistance to Antibody-Drug Conjugates.
Collins DM, Bossenmaier B, Kollmorgen G, Niederfellner G. · · 2019 · cited 109× · PMID 30897808 · DOI 10.3390/cancers11030394 -
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 -
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 -
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 -
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 -
Therapeutic Antibodies for Myeloid Neoplasms-Current Developments and Future Directions.
Schürch CM. · · 2018 · cited 30× · PMID 29868474 · DOI 10.3389/fonc.2018.00152 -
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 -
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:
- PubMed search for NCT02221310
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gemtuzumab Ozogamicin
Trials testing the same drug.
- NCT06917911 — Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin · Phase 2 · not yet recruiting
- NCT05564390 — MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Wi · Phase 2 · recruiting
- NCT04915612 — Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patient · Phase 1 · completed
- NCT04207190 — Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · completed
- NCT04293562 — A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed A · Phase 3 · recruiting
Other recruiting trials for Acute Myelogenous Leukemia
Currently open trials in the same condition.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
- NCT06680661 — ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis · Phase 2 · recruiting
- NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
- NCT05974150 — Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia · recruiting
Other New York Medical College trials
Trials by the same sponsor.
- NCT06617286 — CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma · Phase 1, PHASE2 · not yet recruiting
- NCT07225972 — Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC · Phase 3 · not yet recruiting
- NCT07013565 — Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL · Phase 2 · active not recruiting
- NCT05987124 — Defibrotide Dose-escalation for SOS Post-HSCT · Phase 2 · recruiting
- NCT05564598 — CMV CTLs in Neonates With CMV Infection · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02221310 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by New York Medical College
- Last refreshed: 26 October 2023
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