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| ID | Type | Description | Link |
|---|---|---|---|
| Rituxan+BEAM | Other Identifier | BCM Center for Cell and Gene Therapy |
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| Name | Class |
|---|---|
| The Methodist Hospital Research Institute | OTHER |
| Center for Cell and Gene Therapy, Baylor College of Medicine | OTHER |
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High-dose chemotherapy followed by autologous (the patient's own) peripheral blood (circulating blood) stem cell (cells that divide to form white cells, red cells and cells that help clot) transplantation is a conventional treatment for patients with lymphoma (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse (recurrence of disease). For patients who did not have a complete response after traditional chemotherapy, the chance is high that the tumor will return even after high-dose chemotherapy. To improve the response and decrease the chance of relapse, doctors have used rituximab, an antibody that kills lymphoma cells, both before and after transplantation. These doctors have reported that more patients had control of the tumor for an extended period of time using rituximab with high-dose chemotherapy with autologous stem cell transplantation. How widely this is applicable is not known.
The purpose of this clinical research trial is to confirm that there is a good control of tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional stem cell transplantation.
Subjects will receive the chemotherapy through a plastic tube (catheter) placed into a vein under the collarbone. The antibody rituximab is given on the day of admission. The subject will also start a six-day course of chemotherapy at that time. The chemotherapy will consist of the following drugs: BCNU, etoposide also called VP-16, Ara-C also called cytosine arabinoside, and melphalan. BCNU is given on the first day, Ara-C and VP-16 on the second, third, fourth and fifth days, and melphalan on the sixth day. The infusion of blood stem cells is given through the catheter the day after the last dose of chemotherapy. This is called Day 0. A week later the subject will receive shots under the skin of Neupogen to help the stem cells grow quickly. Three additional doses of rituximab are given weekly starting 2 weeks later. If the subject recovers and is discharged from the hospital before getting all the doses of rituximab, they can receive the remainder in clinic.
Patients will remain in the hospital for approximately 3-4 weeks, and in the Houston area for about 30 days from the infusion of the donor cells. The patient will have blood, urine, bone marrow, and x-ray examinations performed as necessary to monitor the results of treatment. They will have blood tests daily while hospitalized.
As an outpatient, the patient will be monitored to make sure their immune system (system in the body that helps protect the body and fights bacterial, viral and fungal infections) is recovering, and the patient may require additional infusions of immunoglobulins (infection-fighting blood proteins) until the blood protein levels are safe. The patient will also be taking antibiotic pills for about 6 months to prevent infections. They will have x-rays and other diagnostic tests (PET scans) every 6-12 months during the next 5 years to make sure the tumor stays under control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEAM+R: Autologous Stem Cell Transplant | Other | Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan | Drug | Given on Day -1 Melphalan is administered according to the current SOP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas | 12 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Median Days to Neutrophil Engraftment | Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings. | 30 days post-transplant |
| Number of Participants With Overall Best Response Achieved After Transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Carrum, MD | Associate Professor; Director-Adult Outpatient Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States | ||
| The Methodist Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituxan+BEAM: Autologous Stem Cell Transplant | Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituxan+BEAM: Autologous Stem Cell Transplant | Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Disease-free Survival | Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas | Posted | Number | 95% Confidence Interval | percentage of participant | 12 months post-transplant |
|
|
Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant.
Only related adverse events were collected for this study.
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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 | Rituxan+BEAM: Autologous Stem Cell Transplant | Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular/ General - Other | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Carrum, MD | Baylor College of Medicine | GCarrum@houstonmethodist.org |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| D002330 | Carmustine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| Ara-C | Drug | 200 mg/m2 IB BID given on Days -5, -4, -3, -2 |
|
|
| VP-16 | Drug | 200 mg/m2 IV BID given on Days -5, -4, -3, -2 |
|
|
| BCNU | Drug | BCNU 300 mg/m2 IV given on Day -6 |
|
|
| Rituxan | Drug | 375 mg/m2 IB given on Days -6, +14, +21, +28 |
|
|
| Stem Cells | Drug | Stem cells given on Day 0 |
|
|
Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir. |
| 3 months post-transplant |
| Houston |
| Texas |
| 77030 |
| United States |
| Death |
|
| Lost to Follow-up |
|
| Ongoing |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Disease at diagnosis | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Median Days to Neutrophil Engraftment | Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings. | All of the participants enrolled in the study engrafted. | Posted | Median | Full Range | days | 30 days post-transplant |
|
|
|
| Secondary | Number of Participants With Overall Best Response Achieved After Transplantation | Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir. | Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin's disease. | Posted | Number | participants | 3 months post-transplant |
|
|
|
| 1 |
| 75 |
| 2 |
| 75 |
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
|
| Infection without neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Pain - Other | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 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 |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Relapsed Disease or Progressive Disease (PD) |
|