Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS
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ClinicalTrials.gov Identifier: NCT02221310 |
Recruitment Status :
Recruiting
First Posted : August 20, 2014
Last Update Posted : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Myelogenous Leukemia Myelodysplastic Syndrome | Drug: Gemtuzumab Ozogamicin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamide (Immunochemotherapy) and Allogeneic Stem Cell Transplantation in Patients With High Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
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Experimental: Gemtuzumab Ozogamicin
Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.
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Drug: Gemtuzumab Ozogamicin
Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning
Other Name: Mylotarg |
- Response rate [ Time Frame: 1 year ]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

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Ages Eligible for Study: | up to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221310
Contact: Mitchell S Cairo, MD | 914-594-2150 | mitchell_cairo@nymc.edu | |
Contact: Erin Morris, RN | 714-964-5359 | erin_morris@nymc.edu |
United States, New York | |
New York Medical College | Recruiting |
Valhalla, New York, United States, 10595 | |
Contact: Sandra Fabricatore, RN, PNP 914-594-2152 sandra.fabricatore@wmchealth.org | |
Contact: Erin Morris, RN 714-964-5359 erin_morris@nymc.edu | |
Principal Investigator: Mitchell S Cairo, MD |
Principal Investigator: | Mitchell S Cairo, MD | New York Medical College |
Responsible Party: | Mitchell Cairo, Principal Investigator, New York Medical College |
ClinicalTrials.gov Identifier: | NCT02221310 |
Other Study ID Numbers: |
NYMC-515 L-10,349 ( Other Identifier: New York Medical College ) |
First Posted: | August 20, 2014 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
targeted therapy leukemia MDS immune therapy |
Leukemia Preleukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms |
Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Gemtuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |