- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669890
Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML (High Risk)
Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamid and Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ Acute Myelogenous Leukemia/Myelodysplastic Syndrome/Juvenile Myelomonocytic Leukemia
The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well tolerated.
This study will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (Part A)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York City, New York, United States, 10032
- Morgan Stanley Children's Hospital of NYP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Eligibility
Inclusion Criteria:
Disease Status
- AML Induction Failure
- AML in 1st, 2nd, or 3rd Relapse (>10% bone marrow blasts)
- AML greater than or equal to 3rd CR
- MDS with >6% bone marrow blasts at diagnosis
- Secondary MDS with less than or equal to 5% bone marrow myeloblasts at diagnosis
- JMML with >6% bone marrow myeloblasts at diagnosis
Disease Immunophenotype Patients (AML only) receiving gemtuzumab ozogamicin must express minimum of >10% or =10% CD33 positivity. Patients with <10% CD33 positivity will not receive gemtuzumab ozogamicin.
Organ Function
Patients must have adequate organ function as defined below:
- Adequate renal function defined as:
- Serum creatinine <1.5 x normal, or
- Creatinine clearance or radioisotope GFR 40 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range
- Adequate liver function defined as:
- Total bilirubin 1.5 x normal, or SGOT (AST) or SGPT (ALT) <2.0 x normal or =2.0 x normal
- Adequate cardiac function defined as:
- Shortening fraction of >27% by echocardiogram, or
- Ejection fraction of >47% by radionuclide angiogram or echocardiogram
- Adequate pulmonary function defined as:
- DLCO >55% or =55% by PFT
- For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air
Exclusion Criteria:
- Patients with active CNS AML/JMML/MDS disease at time of conditioning therapy
- Female patients who are pregnant (positive HCG)
- Karnofsky <50% or Lansky <50% if 10 years or less
- Age >65 years
- Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study 515
|
Conditioning Regimen
Other Names:
Dose Escalation
Other Names:
Conditioning Regimen
Other Names:
(Unrelated Donors only)
Other Names:
GVHD Prophylaxis
Other Names:
GVHD Prophylaxis
Other Names:
GVHD Prophylaxis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal tolerated dose or tolerable dose of Gemtuzumab Ozogamicin (anti-CD33 immunotoxin) therapy combined with Busulfan/ Cyclophosphamide in the conditioning regimen prior to AlloSCT in patients with high risk CD33+ AML/JMML/MDS
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes, if applicable, of minimal residual disease (cytogenetics, FISH, RT-PCR) in patients with high risk CD33+ AML/JMML/MDS after AlloSCT.
Time Frame: 1 year
|
1 year
|
Progression Free Survival (PFS), overall survival (OS), and disease free survival (DFS), (if applicable), following GO, Bu/CY and AlloSCT in patients with high risk CD33+ AML/JMML/MDS.
Time Frame: 1 year
|
1 year
|
Quality of life before and after GO, Bu/CY conditioning and AlloSCT in patients with high risk CD33+ AML/JMML/MDS
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mitchell S Cairo, MD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Myelodysplastic-Myeloproliferative Diseases
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Leukemia
- Preleukemia
- Leukemia, Myelomonocytic, Juvenile
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Antitubercular Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Cyclophosphamide
- Methotrexate
- Tacrolimus
- Mycophenolic Acid
- Busulfan
- Thymoglobulin
- Gemtuzumab
Other Study ID Numbers
- AAAA2533
- CHNY-01-515 (Other Identifier: CU)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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