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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
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The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.
The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.
-As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 2 umbilical cord units: Second cord blood unit modulated with ProHema |
|
| Group 2 | Active Comparator | 2 umbilical cord units: First cord blood unit modulated with ProHema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | 30mg/m2/day IV x 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety of ProHema modulated umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to engraftment of umbilical cord blood units | 2 years | |
| Fractional chimerism of transplanted cord blood units | 2 years | |
| Rates of acute and chronic GVHD |
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Inclusion Criteria:
Exclusion Criteria:
The following hematologic malignancies are excluded:
Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension
Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected hemoglobin
Renal disease: serum creatinine > 2.0mg/dl
Hepatic disease: serum bilirubin > 2.0mg/dl (expect in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT > 3 x upper limit of normal
Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
HIV antibody
Uncontrolled infection
Pregnancy or breast feeding mother
Inability to comply with the requirements for care after allogeneic stem cell transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Corey Cutler, MD, MPH, FRCP(C) | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23996087 | Derived | Cutler C, Multani P, Robbins D, Kim HT, Le T, Hoggatt J, Pelus LM, Desponts C, Chen YB, Rezner B, Armand P, Koreth J, Glotzbecker B, Ho VT, Alyea E, Isom M, Kao G, Armant M, Silberstein L, Hu P, Soiffer RJ, Scadden DT, Ritz J, Goessling W, North TE, Mendlein J, Ballen K, Zon LI, Antin JH, Shoemaker DD. Prostaglandin-modulated umbilical cord blood hematopoietic stem cell transplantation. Blood. 2013 Oct 24;122(17):3074-81. doi: 10.1182/blood-2013-05-503177. Epub 2013 Aug 30. |
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| Melphalan |
| Drug |
100 mg/m2/day IV x 1 day |
|
| Antithymocyte Globulin | Drug | 1mg/kg/day x 4 days |
|
| Sirolimus | Drug | GVHD Prophylaxis: Target range 3-12 ng/ml |
|
| Tacrolimus | Drug | GVHD Prophylaxis: Target range 5-10 ng/ml |
|
| 2 years |
| 30- and 100-day treatment related mortality | 2 years |
| Measures of immune reconstitution and relapse-free and overall survival at 1 and 2 years after transplantation | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D008558 | Melphalan |
| D000961 | Antilymphocyte Serum |
| D020123 | Sirolimus |
| D016559 | Tacrolimus |
| 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 |
| D018942 | Macrolides |
| D007783 | Lactones |
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