CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Anti-Thymocyte Globulin +10 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓CD20+ lymphoid malignancies in relapse after ≥1 prior regimen, or T-cell lymphoid malignancies (relapsed or newly diagnosed with high-risk features like IPI ≥2)
  • ✓Fully-matched or one-antigen mismatched sibling or unrelated donor required
  • ✓Left ventricular ejection fraction ≥40%, no uncontrolled arrhythmias or symptomatic heart disease
  • ✓FEV1, FVC, and DLCO ≥40%
Key exclusion· 15
  • ✕History of anaphylaxis following exposure to rituximab, Velcade, boron, or mannitol
  • ✕Grade 3 or 4 NCI toxicity with prior bortezomib therapy
  • ✕Active CNS disease
  • ✕Known HIV, HTLV-I, hepatitis B, or hepatitis C infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00439556
NCT00439556Phase 2Completed
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Bortezomib (Velcade®) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoid Malignancies

M.D. Anderson Cancer Center·interventional·Posted Feb 23, 2007·Updated Sep 10, 2019

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Anti-Thymocyte Globulin, and 9 other interventions for CD20 Positive and 3 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects and best dose of bortezomib when given with chemotherapy and to see how well they work in treating participants with lymphoid malignancies undergoing stem cell transplant. Giving chemotherapy before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells called graft versus host disease. Giving tacrolimus and methotrexate after the transplant may stop this from happening. Giving bortezomib and chemotherapy may work better in treating participants with lymphoid malignancies undergoing a stem cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCD20 Positive, Hematopoietic and Lymphoid Cell Neoplasm, Lymphocytic Neoplasm, Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 23, 2007
Enrollment StartFeb 13, 2007
Primary CompletionJun 7, 2018
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 19.4 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic hematopoietic stem cell transplantation

Anti-Thymocyte Globulinbiological

Given IV

Bortezomibdrug

Given IV

Carmustinedrug

Given IV

Cytarabinedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC

Melphalandrug

Given IV

Methotrexatedrug

Given IV

Rituximabbiological

Given IV

Tacrolimusdrug

Given IV and PO