Phase 2
Completed N=40
Bortezomib and Chemotherapy in Treating Participants With Lymphoid Malignancies Undergoing Stem Cell Transplant
CD20 Positive · Hematopoietic and Lymphoid Cell Neoplasm · Lymphocytic Neoplasm · Lymphoma
Source: ClinicalTrials.gov NCT00439556 ↗
Enrolled (actual)
40
Serious AEs
20.5%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicity (DLT) — 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity (DLT) |
0; 0; 0 | — |
| PRIMARY Disease-free Survival |
16; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Any histological subtype of CD20+ lymphoid malignancies or T-cell lymphoid malignancies.
- Patients with CD20+ lymphoid malignancies in relapse after failing >= 1 prior regimen of conventional treatment and not eligible for non-myeloablative transplant. Patients with T-cell lymphoid malignancies can either be in relapse or newly diagnosed with high risk features (such as high International Prognostic Index [IPI] of >= 2).
- Patients with prior non-myeloablative transplant are eligible if not from the same donor.
- A fully-matched or one-antigen mismatched sibling or unrelated donor.
- Left ventricular ejection fraction (EF) >= 40% with no uncontrolled arrhythmias or symptomatic heart disease.
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 40%.
- Serum creatinine = 140/90).
- Uncontrolled chronic diarrhea.
- A prior allogeneic transplant from the same donor.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patient has received other investigational drugs within 3 weeks before enrollment.
- Active peripheral neuropathy greater or equal to grade 2.
Data sourced from ClinicalTrials.gov (NCT00439556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.