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To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.
Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.
This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I Rituxan and BEAM post-autologous stem cell transplant | Experimental | Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituxan | Drug | 375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Disease response at day 100 | 100 day |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Survival time from diagnosis until death | diagnosis until death |
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Inclusion Criteria:
Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR).
o Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
At least 19 years of age
Signed written informed consent
Expected survival of at least 6 months
WHO performance status greater or equal to 2
Male or female subjects of reproductive potential who are able to follow accepted birth control measures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie M Vose, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, Section of Oncology/Hematology | Omaha | Nebraska | 68198 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| BEAM | Drug | BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1 |
|
| Autologous stem cell transplant | Procedure | following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |