Clinical trial · Interventional
Carfilzomib Consolidation Therapy After Autologous Stem Cell Transplantation (ASCT) for Mantle Cell Lymphoma (MCL), T-cell Lymphoma (TCL), and Diffuse Large B-Cell Lymphoma (DLBCL)
Carfilzomib Consolidation Therapy After Autologous Stem Cell Transplantation (ASCT) for Patients With Mantle Cell (MCL), T-cell (TCL), and Diffuse B-Cell Lymphoma (DLBCL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given to patients with lymphoma after a stem cell transplant. The safety of this drug will also be studied. Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Carfilzomib
- description
- Carfilzomib given in four doses, days 1, 2, 15 and 16, every 28 days for 6 months starting within 6 months post ASCT. Doses given in an escalated phase 1 design, starting at 20/20 mg/m2, later increased to 20/27 mg/m2, 20/36 mg/m2 and 20/45 mg/m2. CFZ dose based on actual body surface area at baseline (cycle 1). Patients with a body surface area (BSA) greater than 2.2 m2 receive dose based upon a 2.2 m2 BSA. Adjustments are not made if weight gains or losses are less than or equal to 20% from baseline. Dexamethasone 4 mg by vein or mouth prior to each CFZ dose in cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, then it should be restarted and administered prior to subsequent doses for reactions.
- interventionNames
- Drug: Carfilzomib
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Carfilzomib (CFZ) After Autologous Stem Cell Transplantation (ASCT)
- timeFrame
- 56 days
- description
- Maximum tolerated dose (MTD) defined as dose with a posterior probability of treatment-related dose-limiting toxicity (DLT) during the first 56 days closest to the target of 30%. DLT defined as: equal or greater than Grade (G) 2 neuropathy with pain, equal or greater than G3 non-hematologic toxicity, G4 neutropenia greater than 7 days, febrile neutropenia, G4 thrombocytopenia lasting for more than 7 days despite withholding CFZ, G3/4 thrombocytopenia with bleeding, or equal or greater than Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal by day 56.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with mantle cell lymphoma, T-cell lymphoma, and diffuse large b-cell lymphoma within 6 months post autologous transplantation and without relapse. 2. Age \>/= 18 years to \</= 70 years. 3. Absolute neutrophil count (ANC) \>/= to 1.5 x 10\^9/L; Platelets \> 75 x 10\^9/L. 4. No active infection. 5. Performance status: Eastern Cooperative Oncology Group (ECOG) 2 or less or Karnofsky of at least 60. 6. Cardiac EF \>/= 45% by 2D-Echo. 7. Serum creatinine less than 1.6 mg/dl and Creatinine Clearance \>/= to 30 mL/min. 8. Liver function tests less than 2x upper limit of normal range (unless related to medications or Gilbert's disease). 9. Females of childbearing potential who are not pregnant or breastfeeding. 10. Patient or legally authorized representative able to sign informed consent. Exclusion Criteria: 1. Glucocorticoid therapy (prednisone \>30 mg/day or equivalent within 14 days of first dose. 2. POEMS syndrome. 3. Plasma cell leukemia or circulating plasma cells \>/= 2 X 10\^9/L. 4. Waldenstrom's Macroglobulinemia. 5. Patients with known amyloidosis. 6. Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 21 days of first dose. 7. Patients previously randomized in any other Onyx-sponsored Phase 3 trial. 8. Active congestive heart failure (NYHA Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months. 9. Acute active infection requiring systemic antibiotics, antiviral (except antiviral directed at Hepatitis B) or antifungal agents within 14 days of first dose. 10. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B SAg or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed). 11. Patients with known cirrhosis. 12. Second malignancy within past three years except: a. adequately treated basal or squamous cell skin cancer. b. carcinoma in situ of the cervix. c. prostate cancer \< Gleason Score 6 with stable prostatic specific antigen (PSA) over the past three months. d. breast cancer in situ with full surgical resection. e. treated medullary or papillary thyroid cancer. 13. Patients with myelodysplastic syndrome. 14. Significant neuropathy (Grades 3 to 4, or Grade 2 pain). 15. Known hypersensitivity to carfilzomib. 16. Known contraindication to dexamethasone. 17. Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days of first dose. 18. Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol compliance.
References
Publications (0)
Data not yet available