Clinical trial · Interventional
Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders
- 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety
- measure
- Efficacy
Secondary outcomes (4)
- measure
- Progression-free survival
- measure
- Mean and median duration of response
- measure
- Mean and median duration of progression-free and overall survival
- measure
- Probability of polymerase chain reaction negativity after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types:
* Chronic lymphocytic leukemia
* Absolute lymphocytosis greater than 5,000/mm\^3
* B-cell phenotype (CD 19, 20, or 23 positive) with more than 30% bone marrow lymphocytes
* B-cell small lymphocytic lymphoma
* Marginal zone B-cell lymphoma
* Grade I-III follicle center cell lymphoma
* Waldenstrom's macroglobulinemia
* Mantle cell lymphoma
* At least 1 unidimensionally measurable lesion for patients with non-Hodgkin's lymphoma
* At least 2 cm by conventional techniques
* No active brain metastases
* Treated CNS disease allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3 (500/mm\^3 if there is lymphomatous involvement of the bone marrow)
* Platelet count ≥ 50,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT ≤ 2.5 times ULN (4 times ULN if there is liver involvement)
Renal
* Creatinine ≤ 2 times ULN OR
* Creatinine clearance ≥ 50 mL/min
Cardiovascular
* No history of orthostatic hypotension
* No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 3 months
* No New York Heart Association class III or IV congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No uncontrolled hypertension requiring manipulation of antihypertensive medications
* No evidence of any of the following by echocardiogram:
* Acute ischemia
* Significant conduction abnormality
* Bifascicular block
* 2\^nd- or 3\^rd-degree atrioventricular block
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No other immunodeficiency
* No known severe hypersensitivity reaction to agents containing Cremophor EL
* No ongoing or active infection
* Febrile episodes up to 38.5° Celsius allowed in the absence of infection
* No other concurrent uncontrolled illness that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
* No preexisting grade II or greater sensory neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 months since prior monoclonal antibodies (unless there is clearly documented evidence of disease progression after therapy)
* At least 3 months since prior radioimmunotherapy
* No prior allogeneic bone marrow transplantation
Chemotherapy
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin, nitrosoureas, or carmustine) and recovered
* No more than 4 prior chemotherapy regimens (including high-dose chemotherapy \[HDC\] for patients with relapsed disease \> 100 days after completion of HDC)
* Cytoreduction plus HDC is considered 1 chemotherapy regimen
* No other concurrent chemotherapy
Endocrine therapy
* At least 7 days since prior steroids
Radiotherapy
* More than 3 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgery
Other
* Use of antibiotics for marginal zone lymphoma does not count as a prior therapy
* No other concurrent investigational agents
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available