Clinical trial · Interventional
A Phase I/II Trial of VELCADE & Gemcitabine for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma
A Phase I/II Trial of Combination Bortezomib (VELCADE) and Gemcitabine Therapy for Patients With Relapsed or Refractory Aggressive B- and T-cell Non-Hodgkin's Lymphoma
NCT00290706CI-TRIAL-00038801terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed per Data Monitoring Committee due to lack of efficacy
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with bortezomib may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with gemcitabine and to see how well they work in treating patients with relapsed or refractory B-cell or T-cell non-Hodgkin's 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine 800 mg/m2 + Bortezomib IVP over 3-5 seconds
- description
- Gemcitabine dose of 800 mg/m2 over 30 minutes followed by Bortezomib IVP given over 3-5 seconds on day 1 and day 15 of each cycle every 28 days for up to 8 cycles.
- interventionNames
- Drug: bortezomib
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Response Rate in Patients With Relapsed or Refractory B- and T-cell NHL With Gemcitabine and Bortezomib Combination Treatment.
- timeFrame
- At screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8
- description
- Response rate in patients with relapsed or refractory B- and T-cell NHL with Gemcitabine and Bortezomib combination treatment will be defined as the number of patients with Complete Remission \[CR\] and Partial Remission \[PR\]. CT scans at screening and after completing cycle 3, cycle 6 and 30 days after Cycle 8 assessed by the Response Criteria for Non-hodgkins Lymphoma will be used to determine response where: CR=Complete disappearance of all detectable clinical and radiographic evidence of disease PR=\> 50% decrease in SPD of the six largest dominant nodes or nodal masses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of B- or T-cell non-Hodgkin's lymphoma (NHL)
* Intermediate histology B-cell NHL, including any of the following:
* Diffuse large B-cell lymphoma
* Transformed large cell lymphoma
* Any T-cell NHL histology
* Cutaneous T-cell lymphoma (CTCL) or mycosis fungoides (MF) allowed
* Relapsed or refractory disease, defined as disease progressed after prior complete remission (CR), partial remission (PR), or stable disease (SD) to last therapy OR failure to achieve CR, PR, or SD after completion of last therapy
* Must have received 1-3 prior therapeutic regimens
* Cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) AND cyclophosphamide, vincristine, and prednisone (CVP) OR CHOP with rituximab (CHOP-R) AND CVP with rituximab (CVP-R) is considered 1 regimen
* Monoclonal antibody (e.g., rituximab) given as maintenance therapy is considered 1 regimen
* Salvage chemotherapy followed by an autologous stem cell transplant is considered 1 regimen
* No more than 7 prior therapeutic regimens for patients with CTCL or MF
* No mantle cell lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* At least 50,000/mm\^3 if documented bone marrow involvement
* Hemoglobin ≥ 8.0 g/dL
* AST and ALT ≤ 3 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Bilirubin ≤ 2 times ULN
* Creatinine ≤ 2.0 mg/dL
* No known history of HIV infection
* No other active infection
* No uncontrolled hypertension
* No peripheral neuropathy ≥ grade 2 within the past 2 weeks
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart failure
* No uncontrolled angina
* No severe uncontrolled ventricular arrhythmias
* No acute ischemia or active conduction system abnormalities by ECG
* No hypersensitivity to bortezomib, boron, or mannitol
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier-method contraception
* No serious medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
* Prior autologous and/or allogeneic stem cell transplantation allowed
* More than 3 weeks since prior chemotherapy, radiotherapy, or immunotherapy
* More than 3 weeks since prior systemic biologic anticancer therapy
* More than 3 weeks since prior systemic corticosteroids (e.g., oral prednisone \> 10 mg per day)
* More than 2 weeks since prior investigational drug
* No prior bortezomib or gemcitabine hydrochloride
* No other concurrent systemic cytotoxic chemotherapy or investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.