NCT02221310

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 7, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

11.3 years

First QC Date

July 31, 2014

Last Update Submit

October 24, 2023

Conditions

Acute Myelogenous LeukemiaMyelodysplastic Syndrome

Keywords

targeted therapyleukemiaMDSimmune therapy

Outcome Measures

Primary Outcomes (1)

  • Response rate

    overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS

    1 year

Study Arms (1)

Gemtuzumab Ozogamicin

EXPERIMENTAL

Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.

Drug: Gemtuzumab Ozogamicin

Interventions

Gemtuzumab OzogamicinDRUG

Gemtuzumab Ozogamicin 7.5 mg/m\^2/dose given IV over 2 hours once during conditioning

Also known as: Mylotarg
Gemtuzumab Ozogamicin

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Disease Status:
  • History of AML Induction/Reinduction Failure
  • AML 1st Complete Remission (CR) with poor cytogenetics
  • AML 2nd CR with minimal residual disease (MRD)
  • AML 3rd CR
  • AML in refractory relapse but ≤25% bone marrow leukemia blasts
  • MDS with \>6% bone marrow blasts at diagnosis
  • Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis
  • Disease Immunophenotype:
  • Disease must express a minimum of \>/= 10% CD33+ for patients with AML
  • Organ Function:
  • Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood donor, unrelated adult donor

You may not qualify if:

  • Patients with active central nervous system (CNS) AML/MDS disease at time of conditioning therapy
  • Female patients who are pregnant
  • Karnofsky \<50% or Lansky \<50% if 10 years or less
  • Age \>25 years
  • Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

Related Publications (1)

  • Satwani P, Bhatia M, Garvin JH Jr, George D, Dela Cruz F, Le Gall J, Jin Z, Schwartz J, Duffy D, van de Ven C, Foley S, Hawks R, Morris E, Baxter-Lowe LA, Cairo MS. A Phase I study of gemtuzumab ozogamicin (GO) in combination with busulfan and cyclophosphamide (Bu/Cy) and allogeneic stem cell transplantation in children with poor-risk CD33+ AML: a new targeted immunochemotherapy myeloablative conditioning (MAC) regimen. Biol Blood Marrow Transplant. 2012 Feb;18(2):324-9. doi: 10.1016/j.bbmt.2011.11.007. Epub 2011 Nov 9.

    PMID: 22079471BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesLeukemia

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mitchell S Cairo, MD

    New York Medical College

    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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 20, 2014

Study Start

December 7, 2011

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

US(1)