SCT Plus Immune Therapy in Average Risk AML/MDS

NCT02117297 | Completed Phase 2 FDA Drug

• 2 other identifiers: NYMC-504L 10,394
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (3)

• to evaluate incidence of graft failure

  If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.

  Day +42

• to evaluate survival rates

  Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.

  1 year

• to determine toxicity

  to monitor for serious adverse events related to protocol investigational therapy

  1 year

Secondary Outcomes (3)

• Minor histocompatibility antigen

  1 year

• Chimerism

  1 year

• Graft-versus-host disease

  1 Year

Study Arms (1)

Gemtuzumab Ozogamicin

EXPERIMENTAL

Consolidation therapy with GO will be administered between days 60 and 180 post transplantation when the ANC is \>1000/mm3 and platelet count is \>40,000/mm3 untransfused x 3 days after AlloSCT and again at minimum 8 weeks later.

Drug: Gemtuzumab Ozogamicin

Interventions

Gemtuzumab Ozogamicin DRUG

Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.

Also known as: Mylotarg

Gemtuzumab Ozogamicin

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Disease Status:
• AML 1st CR with a matched family donor
• AML 1st CR with unrelated donor
• AML 2nd CR or CRP
• MDS and \< or = 5% bone marrow myeloblasts at diagnosis
• Disease Immunophenotype:
• Disease must express a minimum of \> or = 10% CD33 positivity for patients with AML
• Organ Function:
• Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function

You may not qualify if:

• Patients with active CNS AML disease at time of preparative regimen
• Secondary MDS
• Poor cytogenetics
• Female patients who are pregnant
• Karnofsky \<70% or Lansky \<50% if 10 years or less
• Age \>25 years
• Seropositive for HIV

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mitchell S. Cairo, M.D.

  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: April 8, 2014
• First Posted: April 17, 2014
• Study Start: January 12, 2012
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

US (1)