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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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The goal of this clinical research study is to see if low intensity chemotherapy given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells from a donor can increase the length of remission in patients with leukemia and lymphoma. The safety of this treatment will also be studied.
Rituxan is an antibody made from human and mouse protein. It reacts with a certain antigen on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. 90Y Zevalin and 111In Zevalin are murine-based antibodies combined with a radioactive agent that can also destroy lymphoma cells. Unlike Rituxan, 90Y Zevalin cannot be traced by regular scanning and requires indium to determine its distribution through the body.
Before treatment starts, patients will have a physical exam, including blood tests and urine tests. Women who are able to have children must have a negative blood pregnancy test. Bone marrow samples will be taken. For bone marrow sampling, a large needle is placed in the hipbone after it has been numbed. The bone marrow is then withdrawn through the needle. Patients will have a chest x-ray, computed tomography (CT) scans, an EKG, and tests of lung function.
Blood tests, urine tests, bone marrow sampling, and x-rays will be done as needed to track the effects of the transplant. Patients will have transfusions of blood and platelets as needed. Blood tests will be done daily while patients are in the hospital.
Patients in this study will receive an unlabeled antibody form of Y2B8 called rituxan by vein followed by a dose of 111In Zevalin by vein. 111In Zevalin includes the radioactive agent indium, which shows up when patients have x-rays or scans. The scans can show where and how fast the drug travels in the body and how long the drug stays in the body. Doctors need to be able to see how much of the drug goes to the tumor and how much goes to normal organs to see if it is safe to give 90Y Zevalin on an outpatient basis. A scan will be taken 48 to 72 hours after 111In Zevalin is given.
If the radiation in the 111In Zevalin is not a threat to normal organs and bone marrow, patients may receive 90Y Zevalin. Seven days after the 111In Zevalin injection, patients will receive a second dose of rituxan followed by a dose of 90Y Zevalin.
Patients will also receive fludarabine and cyclophosphamide daily for 3 days. All of the chemotherapy drugs will be given through a catheter (plastic tube) that extends into the large chest vein. The catheter will be left in place throughout treatment. When chemotherapy is finished, blood stem cells from a donor will be given through the catheter. Granulocyte colony-stimulating factor (G-CSF or GCSF), a hormone that helps the production of blood cells, will be injected under the skin once a day until the neutrophil counts recover in the blood. Patients will receive methotrexate for 3 days post transplant and tacrolimus for 6 months or more to prevent graft versus host disease.
All patients will have complete checkups, including blood and urine tests 2 or 3 times during the first 12 weeks of the study. Tumors will be measured by CT or MRI and gallium scans. Patients will be asked to fill out a survey about quality of life issues (maintaining normal routine, family life, social life, pain). It takes about half an hour to fill out the survey. A bone marrow sample may be taken. A test of heart function will be done. Checkups and tests will be done every 3 months for 1 year and then every 6 months for 4 more years.
Treatment will be given in the hospital at M. D. Anderson. Patients will need to stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston area for about 100 days after the transplant. After that, patients will need to return to Houston from time to time for blood tests, urine tests, and other exams.
This is an investigational study. 90Y-Zevalin is approved by the FDA for relapsed and refractory lymphoma. Its use in this trial, however, is investigational. About 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90Y Zevalin in ASCT | Experimental | Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevalin Radioimmunotherapy | Drug | Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Graft Failure | Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells. | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issa F. Khouri, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22586182 | Derived | Khouri IF, Saliba RM, Erwin WD, Samuels BI, Korbling M, Medeiros LJ, Valverde R, Alousi AM, Anderlini P, Bashir Q, Ciurea S, Gulbis AM, de Lima M, Hosing C, Kebriaei P, Popat UR, Fowler N, Neelapu SS, Samaniego F, Champlin RE, Macapinlac HA. Nonmyeloablative allogeneic transplantation with or without 90yttrium ibritumomab tiuxetan is potentially curative for relapsed follicular lymphoma: 12-year results. Blood. 2012 Jun 28;119(26):6373-8. doi: 10.1182/blood-2012-03-417808. Epub 2012 May 14. |
| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center official website | View source |
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Recruitment Period: October 30, 2002 to September 21, 2010. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 90Y Zevalin in ASCT | Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen. Rituximab : 250 mg/m^2 on day 1 and day 8 Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg Fludarabine : 30 mg/m^2/day x 3 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rituximab | Drug | 250 mg/m^2 on day 1 and day 8 |
|
|
| Fludarabine | Drug | 30 mg/m^2/day for 3 days |
|
|
| Cyclophosphamide | Drug | 750 mg/m^2/day for 3 days, given on the same days as fludarabine, at 4-hour intervals |
|
|
| Allogeneic Stem Cell Transplantation | Procedure | Allogeneic stem cell transplantation 2 days after chemotherapy |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 90Y Zevalin in ASCT | Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen. Rituximab : 250 mg/m^2 on day 1 and day 8 Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg Fludarabine : 30 mg/m^2/day x 3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Graft Failure | Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells. | Posted | Number | participants | 100 days |
|
|
|
9 Years and 1 Month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 90Y Zevalin in ASCT | Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen. Rituximab : 250 mg/m^2 on day 1 and day 8 Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg Fludarabine : 30 mg/m^2/day x 3 | 7 | 70 | 70 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | # of participants affected-1 |
|
| Thrombosis | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| C-Diff Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Viral Hepatitis B reactivation | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| secondary malignancy- Melanoma | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Right Inguinal hernia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Prolonged Hospitalization, Generalized Weakness/Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death due to G.I. GVHD | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary Malignancy-Early Nodular Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death Due to Chronic Liver/G.I GVHD | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neuoropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated ALT | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated Alkaline Phosphatase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Increased Bilirubin | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Increased LDH | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Low Ejection Fraction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Elevated Creatinine | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Altered Mood | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin Dryness | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Altered Mood-Agitation | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fasciitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Issa Khouri, MD / Professor | UT MD Anderson Cancer Center | rvalverde@mdanderson.org |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D016393 | Lymphoma, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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