Clinical trial · Interventional
Bortezomib in Treating Patients With Mantle Cell Lymphoma
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma
NCT00030875CI-TRIAL-00068555completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma * No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy * At least 1 bidimensionally measurable disease site\* * Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR * Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: \*Bone lesions are not considered bidimensionally measurable disease * No pre-existing ascites or pleural effusion * No known CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular * LVEF at least 45% by echocardiogram or MUGA Pulmonary * No pre-existing shortness of breath greater than grade 1 Other: * No uncontrolled bacterial, fungal, or viral infections * No pre-existing edema greater than grade 1 * No pre-existing neuropathy greater than grade 1 * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious illness or medical condition that would preclude study compliance * No geographical conditions that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * Prior rituximab allowed * No prior radioactive monoclonal antibody therapy Chemotherapy: * See Disease Characteristics * No prior high-dose chemotherapy with stem cell transplantation * No more than 2 prior systemic chemotherapy regimens * Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens * No prior flavopiridol * At least 6 weeks since prior chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * No prior radiotherapy to 25% or more of functioning bone marrow * At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered * No concurrent radiotherapy to the sole site of measurable disease Surgery: * At least 2 weeks since prior major surgery Other: * No prior investigational therapy * No other concurrent anticancer therapy * No other concurrent investigational anticancer therapy
References
Publications (3)
- RESULTBelch A, Kouroukis CT, Crump M, Sehn L, Gascoyne RD, Klasa R, Powers J, Wright J, Eisenhauer EA. A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150. Ann Oncol. 2007 Jan;18(1):116-121. doi: 10.1093/annonc/mdl316. Epub 2006 Sep 13. PMID 16971665
- RESULTBelch A, Kouroukis CT, Crump M: Phase II trial of bortezomib in mantle cell lymphoma. [Abstract] Blood 104(11): A-608, 2004.
- RESULTAssouline S, Belch A, Sehn L, et al.: A phase II study of bortezomib in patients with mantle cell lymphoma. [Abstract] Blood 102 (11 Pt 1): A-3358, 2003.