Description:
Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab
Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Title
- Brief Title: SCT Plus Immune Therapy in Average Risk AML/MDS
- Official Title: Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)
Clinical Trial IDs
- ORG STUDY ID:
NYMC-504
- SECONDARY ID:
L 10,394
- NCT ID:
NCT02117297
Conditions
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
Interventions
Drug | Synonyms | Arms |
---|
Gemtuzumab Ozogamicin | Mylotarg | Gemtuzumab Ozogamicin |
Purpose
Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab
Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
Detailed Description
Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) +
Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning
regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab
and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk
AML/MDS meeting eligibility criteria.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Maximum Eligible Age: | 25 Years |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | to evaluate incidence of graft failure |
Time Frame: | Day +42 |
Safety Issue: | |
Description: | If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study. |
Secondary Outcome Measures
Measure: | Minor histocompatibility antigen |
Time Frame: | 1 year |
Safety Issue: | |
Description: | To measure the minor histocompatibility antigen expression on AML tissue, donor and recipient, and the development of MHA specific CTLs post AlloSCT. |
Measure: | Chimerism |
Time Frame: | 1 year |
Safety Issue: | |
Description: | To determine the degree of mixed/complete donor chimerism after RI AlloSCT in patients with average risk AML/MDS. |
Measure: | Graft-versus-host disease |
Time Frame: | 1 Year |
Safety Issue: | |
Description: | To estimate the risk of acute and chronic GVHD following RI AlloSCT and FK506/MMF GVHD prophylaxis in patients with average risk AML/MDS. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | New York Medical College |
Last Updated
May 27, 2021