Bortezomib and Chemotherapy in Treating Participants With Lymphoid Malignancies Undergoing Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00439556|
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|CD20 Positive Hematopoietic and Lymphoid Cell Neoplasm Lymphocytic Neoplasm Lymphoma||Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Biological: Anti-Thymocyte Globulin Drug: Bortezomib Drug: Carmustine Drug: Cytarabine Drug: Etoposide Biological: Filgrastim Drug: Melphalan Drug: Methotrexate Biological: Rituximab Drug: Tacrolimus||Phase 2|
I. To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Velcade (bortezomib) in patients with lymphoid malignancies undergoing allogeneic peripheral blood stem cell or bone marrow transplantation.
II. To determine the 1-year disease-free-survival (DFS) and the toxicity profile of Velcade (bortezomib) in patients with lymphoid malignancies undergoing allogeneic peripheral blood stem cell or bone marrow transplantation.
I. To compare the incidence of graft versus host disease (GVHD) with historical controls.
OUTLINE: This is a dose-escalation study of bortezomib.
Participants receive carmustine intravenously (IV) over 1 hour on day -6, cytarabine IV over 1 hour twice daily (BID) on days -5 to -2, etoposide IV over 3 hours BID on days -5 to -2, and melphalan IV over 30 minutes on day -1. Participants also receive rituximab IV on days -13, -6, +1, and +8, and bortezomib IV over 1 minute on days -13, -6, -1, and +2. Participants receiving a matched unrelated or mismatched donor transplant also receive anti-thymocyte globulin IV over 4-6 hours on days -6 and -5. Participants then undergo allogeneic hematopoietic stem cell transplantation over 30-45 minutes on day 0 and receive filgrastim subcutaneously (SC) once daily (QD) starting on day +7 until blood counts return to normal level. Participants receive tacrolimus IV starting on day -2 changing to orally (PO) before leaving the hospital for 6-8 months after the transplant. Participants also receive methotrexate IV over a few minutes on days +1, +3, and +6 and those receiving a matched unrelated or mismatched donor transplant also receive methotrexate IV on day +11.
After completion of study treatment, participants are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bortezomib (Velcade®) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoid Malignancies|
|Actual Study Start Date :||February 13, 2007|
|Actual Primary Completion Date :||June 7, 2018|
|Actual Study Completion Date :||June 7, 2018|
Experimental: Treatment (chemotherapy, transplant, filgrastim, tacrolimus)
See Detailed Description
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic hematopoietic stem cell transplantation
Biological: Anti-Thymocyte Globulin
Given IV and PO
- Maximum tolerated dose of bortezomib defined as the highest dose level at which 0/6 or 1/6 patients experience dose limiting toxicity (DLT) (Phase I) [ Time Frame: Up to 90 days after start of treatment ]DLT will be defined as a grade 3 or 4 neurological toxicity, graft failure, or death from graft versus host disease within the first 90 days.
- Disease-free survival (Phase II) [ Time Frame: At 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439556
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Issa Khouri||M.D. Anderson Cancer Center|