Clinical trial · Interventional
Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Epothilone B Analog BMS-247550 (NSC 710428) in Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
NCT00058019CI-TRIAL-00014674completedPhase 2Results postedClinicalTrials.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)
This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Grade 3 Follicular Lymphoma | Grade 3 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy)
- description
- Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
- interventionNames
- Drug: ixabepilone
Primary outcomes (2)
- measure
- Objective Overall Response Rate
- timeFrame
- up to 3 years
- description
- The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
- measure
- Safety and Toxicity of Ixabepilone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
* Grade III follicular center
* Diffuse large B-cell
* Mantle cell
* Primary mediastinal B-cell
* Burkitt's
* High-grade B-cell (Burkitt-like)
* Anaplastic large cell of 1 of the following subtypes:
* CD30-positive
* T-cell
* Null cell
* Hodgkin's-like
* Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts:
* Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy
* Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
* No progressive disease after the most recent prior therapy
* Measurable disease
* At least 1 bidimensionally measurable lesion at least 10 mm by conventional techniques or clinical exam
* Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
* Patients requiring debulking prior to transplant allowed
* No known CNS involvement by lymphoma
* Prior CNS disease that has been successfully treated in patients with relapsed disease exclusively outside of the CNS may be allowed by the principal investigator
* Performance status - ECOG 0-2
* More than 3 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 2.5 times upper limit of normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550
* No peripheral neuropathy grade 2 or greater
* No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse)
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness
* No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy
* No CSFs during first course of study therapy
* No concurrent filgrastim-SD/01
* No concurrent immunotherapy
* See Disease Characteristics
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No other concurrent chemotherapy
* No concurrent hormonal therapy
* At least 4 weeks since prior radiotherapy
* No concurrent therapeutic radiotherapy
* At least 4 weeks since prior surgery
* Recovered from prior therapy
* At least 7 days since prior cimetidine
* No concurrent cimetidine
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer medications
* No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatumReferences
Publications (0)
Data not yet available
No reference posted for this study.