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| Name | Class |
|---|---|
| Jazz Pharmaceuticals | INDUSTRY |
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This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPX-351 Salvage Therapy and Transplant | Experimental | Subjects will receive CPX-351 salvage chemotherapy on Day -21, -19, and -17 as a bridge to allogeneic stem cell transplantation using a Fludarabine/Melphalan/rATG conditioning regimen and a haplo-cord graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPX-351 | Drug | Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) | 1 year |
| Neutrophil Engraftment | Evaluate the time to neutrophil engraftment, defined as the first day in which absolute neutrophil count (ANC) >500/mm3 for three consecutive days | 100 days |
| Overall Survival at Day 100, 6 months, and 1 year | Evaluate survival of subjects alive, with or without presence of disease, at the designated time points | Day 100, 6 months, and 1 year post-transplant |
| Disease-Free Survival at Day 100, 6 months, and 1 year | Evaluate survival of subjects alive without disease at the designated time points | Day 100, 6 months, and 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Relapse Mortality | Death that cannot be explained by persistence, relapse, or progression of underlying disease | Day 100 |
| Relapse Rate | Time to first relapse or progression of underlying disease after initiation of protocol therapy |
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Inclusion Criteria:
Subject must have refractory or relapsed Acute Myeloid Leukemia (AML) according to previously established criteria:
Subjects with Myelodysplastic Syndrome (MDS):
(a) Either Refractory Anemia with Excess Blasts I or Refractory Anemia with Excess Blasts II (RAEB I or RAEB II)
Karnofsky performance status ≥ 70
Willing to participate as a research subject and sign an informed consent form
Adequate physical function measured by:
If subject has prior malignancy, must be without any evidence of disease of that prior malignancy for at least 2 years (excludes skin cancers that may have been excised within that 2 year period).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Mayer, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
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| Fludarabine | Drug | Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3) |
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| Melphalan | Drug | Melphalan 140 mg/m2 (Day -2) |
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| Rabbit Anti-Human T-Lymphocyte Globulin | Drug | Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days) |
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| Haplo-Cord Stem Cell Transplantation | Biological | Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit. |
|
| Day 100, 6 months, 1 year |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000629812 | CPX-351 |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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