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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-95084 | |||
| NCI-V96-0809 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.
OBJECTIVES:
OUTLINE: Patients are stratified by number of HLA-incompatible alleles (1 vs 2 or 3).
Patients with graft failure are offered autologous bone marrow transplantation (BMT) or second allogeneic BMT.
Patients are followed at 1, 3, 6, and 12 months and then annually for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candidates for transplant | Experimental | Pts stratified by number of HLA-incompatible alleles(1 vs 2 or 3). Harvest:Begin 6-10 d before transplant,allogeneic BM is harvest & tx in vitro. Begin 5-6 d before transplant,G-CSF-stimulated,PBSC harvest,selected for CD34+ cells,& treatment in vitro. If doable,ABM harvest in event of allogeneic graft failure. Myeloablation:Pts u/g TBI 3x d days -9 to -6, thiotepa IV over 4hrs days -5 & -4, & cyclophosphamide IV days -3 & -2. Transplant:CD34+, E-rosette & T-cell-depleted PBSC infuse over 15mins & T-cell-depleted bone marrow infused over 1-5mins day 0. Pts get G-CSF IV over 30 min begin day 1 & continue til blood counts recover & tapering. Pts get anti-thymocyte globulin IV over 4-6hrs days 8,10,12,&14 & oral methylprednisolone days 8-14 followed by tapered doses days 15-17. See detailed description for more details. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological |
| ||
| filgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| overall disease survival | 2 to 4 years post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate progenitor cell doses and doses of clonable T-cells | 2 years |
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DISEASE CHARACTERISTICS:
One of the following diagnoses:
Acute myelogenous leukemia (AML) meeting 1 of the following conditions:
Failed to achieve first remission after an intensive induction regimen containing an anthracycline and cytarabine
In second remission and not enrolled in a protocol for autologous bone marrow transplantation
Failed to achieve or sustain second remission
In first remission but at high risk of relapse because of 1 of the following factors:
Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:
Chronic myelogenous leukemia (CML) in first or second chronic phase or accelerated phase
Stage IV lymphoblastic lymphoma not in first remission or that failed to achieve a remission within the first 4 weeks of induction therapy
Juvenile CML
Myelodysplastic syndrome
Severe aplastic anemia unresponsive to anti-thymocyte globulin or cyclosporine
No CNS or skin involvement with leukemia
No requirement for mediastinal irradiation
No healthy, HLA-identical related donor of at least 1 year of age or matched unrelated donor available within 4-6 months
Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Age 16 and over:
Under age 16:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Richard J. O'Reilly, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| Biological |
|
| cyclophosphamide | Drug |
|
| cytarabine | Drug |
|
| methylprednisolone | Drug |
|
| thiotepa | Drug |
|
| in vitro-treated bone marrow transplantation | Procedure |
|
| in vitro-treated peripheral blood stem cell transplantation | Procedure |
|
| radiation therapy | Radiation |
|
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D009196 | Myeloproliferative Disorders |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D000069585 | Filgrastim |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D008775 | Methylprednisolone |
| D013852 | Thiotepa |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D013812 | Therapeutics |
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