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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00992446 |
Purpose
RATIONALE: Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells and make them more likely to die. Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus kill any lymphoma cells that remain after transplant.
PURPOSE: This phase II trial is studying the side effects and how well bortezomib and vorinostat work in treating patients with non-Hodgkin lymphoma after an autologous stem cell transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Large Cell Lymphoma Contiguous Stage II Adult Diffuse Large Cell Lymphoma Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Contiguous Stage II Grade 1 Follicular Lymphoma Contiguous Stage II Grade 2 Follicular Lymphoma Contiguous Stage II Grade 3 Follicular Lymphoma Contiguous Stage II Mantle Cell Lymphoma Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3 Follicular Lymphoma Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Stage I Adult Diffuse Large Cell Lymphoma Stage I Adult Diffuse Mixed Cell Lymphoma Stage I Adult Diffuse Small Cleaved Cell Lymphoma Stage I Adult T-cell Leukemia/Lymphoma Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage I Grade 1 Follicular Lymphoma Stage I Grade 2 Follicular Lymphoma Stage I Grade 3 Follicular Lymphoma Stage I Mantle Cell Lymphoma Stage I Mycosis Fungoides/Sezary Syndrome Stage II Adult T-cell Leukemia/Lymphoma Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage II Mycosis Fungoides/Sezary Syndrome Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult T-cell Leukemia/Lymphoma Stage III Cutaneous T-cell Non-Hodgkin Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Mycosis Fungoides/Sezary Syndrome Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult T-cell Leukemia/Lymphoma Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Mycosis Fungoides/Sezary Syndrome |
Drug: rituximab Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Drug: bortezomib Drug: vorinostat Procedure: autologous hematopoietic stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bortezomib and Vorinostat as Maintenance Therapy After Autologous Transplant for Non-Hodgkin's Lymphoma Using R-BEAM or BEAM Conditioning Transplant Regimen |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
All patients receive BEAM as conditioning regimen for transplant. Only patients with CD20+ lymphoma also receive rituximab IV on days -19 and -12. Patients undergo autologous stem cell transplantation on day 0. Patients then receive bortezomib 1.3 mg/m2 IV on days 2 and 8 and oral vorinostat once daily on days 1-14 per 28 day cycle. Vorinostat therapy begins at dose of 200 mg orally daily d1-14 per 28 day cycles for total of 3 cycles. If tolerated, then Vorinostat increased to 300 mg po daily d1-14 for 2 cycles and then if tolerated, increase to 400 mg orally daily d1-14 for 7 cycles. . Treatment with bortezomib and vorinostat repeats for 12 courses in the absence of disease progression or unacceptable toxicity.
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Drug: rituximab
Given IV
Other Names:
Drug: carmustine
Given IV
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Drug: melphalan
Given IV
Other Names:
Drug: bortezomib
Given IV
Other Names:
Drug: vorinostat
Given orally
Other Names:
Procedure: autologous hematopoietic stem cell transplantation
Undergo transplantation
|
PRIMARY OBJECTIVES:
I. Assess toxicities of combining vorinostat and bortezomib as maintenance therapy after ASCT for NHL.
SECONDARY OBJECTIVES:
I. Ability to complete planned therapy. II. Time to disease progression and event-free survival. III. Overall survival.
OUTLINE:
All patients receive carmustine IV over 3 hours on day -7; cytarabine IV twice daily over 3 hours and etoposide IV twice daily over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with CD20+ lymphoma receive additional rituximab IV on days -19 and -12. Patients undergo autologous stem cell transplantation on day 0. Patients then receive bortezomib IV on days 2 and 8 and oral vorinostat once daily on days 1-14 of 28-day cycle. Treatment with bortezomib and vorinostat repeats for total of 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for at least 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
Inclusion Criteria for Transplant:
Inclusion Criteria for Maintenance Therapy:
Exclusion
Exclusion Criteria for Transplant:
Exclusion Criteria for Maintenance Therapy:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Leona A. Holmberg 206-667-6447 | |
| Principal Investigator: Leona A. Holmberg | |
| Principal Investigator: | Leona Holmberg | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Holmberg, Leona, Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00992446 History of Changes |
| Other Study ID Numbers: | 2292.00, NCI-2009-01302 |
| Study First Received: | October 7, 2009 |
| Last Updated: | December 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Autologous Stem cell transplant, NHL, maintenance therapy |
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Leukemia Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, B-Cell Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, Large-Cell, Anaplastic Lymphoma, B-Cell, Marginal Zone |
Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Antibodies, Monoclonal Cytarabine Melphalan Rituximab Carmustine Vorinostat |