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| ID | Type | Description | Link |
|---|---|---|---|
| 95889 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| BMT173 | Other Identifier | OnCore |
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The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.
Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Cytokine-induced Killer Cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIK cells | Drug | 2x10e8 cells/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To document the toxicities of infusion of autologous CIK cells | Day 42 post autologous stem cell transplant | |
| Measure freedom from progression (FFP) | 1 and 2 years post-transplant | |
| Measure event free survival | 1 and 2 years post-transplant | |
| Measure overall survival | 1 and 2 years post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Measure disease response | at day 40-60, day 90, day 180, and yearly |
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Inclusion Criteria:
Patients between 18 and 75 years of age, inclusive candidates for standard autologous SCT who are at high risk for relapse:
Patients must have ECOG performance status < 2
Patients must have adequate renal function with a serum creatinine of < 2 mg/dl or creatinine clearance > 50 ml/min.
Patients must have adequate liver function with a total bilirubin < 2 mg/dl or transaminases < 3 times the upper limit of normal.
Patients must have negative antibody serology for human immunodeficiency virus (HIV1 and 2)
Adult women and minorities will be included. Patients with childbearing potential must use effective contraception.
Patients must sign informed consent prior to initiation of any study-related treatments.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sally Arai | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D002330 | Carmustine |
| D003520 | Cyclophosphamide |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| etoposide | Drug | 60 mg/kg |
|
|
| bcnu | Drug | 15 mg/kg |
|
|
| cyclophosphamide | Drug | 100 mg/kg |
|
|
| gemcitabine | Drug | 1250 mg/m2 |
|
|
| vinorelbine | Drug | 30 mg/m2 |
|
|
| melphalan | Drug | 200 mg/m2 |
|
|
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |