Clinical trial · Interventional
Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
- 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)
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ONTOLOGY_EXACT | 0.98 |
| Nodal Marginal Zone Lymphoma | Nodal Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvocidib Hydrochloride | Drug | Alvocidib | ALIAS |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Pharmacological Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Bortezomib
- Drug: Alvocidib Hydrochloride
- Other: Pharmacological Study
Primary outcomes (1)
- measure
- Recommended phase II dose
- timeFrame
- 21 days
Secondary outcomes (5)
- measure
- Maximum tolerated dose, assessed according to NCI CTCAE v4.0
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * WBC \< 50,000/mm\^3 for patients with circulating tumor cells * No prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone * No neuropathy \>= grade 2 * No other condition that would preclude study participation * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * Prior autologous stem cell transplantation is allowed * No prior allogeneic stem cell transplantation * No other concurrent anticancer agents * No other concurrent investigational agents * Hemoglobin \>= 8 g/dL * Platelet count \>= 100,000/mm\^3 * Absolute neutrophil count \>= 1,500/mm\^3 * Bilirubin =\< 2 times upper limit of normal (ULN) * AST/ALT =\< 3 times ULN * Creatinine =\< 2 times ULN or Creatinine clearance \>= 50 mL/min
References
Publications (0)
Data not yet available