Clinical trial · Interventional
Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy
- 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 liposomal vincristine in treating patients who have refractory or relapsed 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal vincristine sulfate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed aggressive non-Hodgkin's lymphoma including:
* Peripheral T-cell lymphoma not otherwise specified
* Anaplastic large null-/T-cell lymphoma
* Diffuse large B-cell lymphoma including:
* Primary mediastinal large B-cell lymphoma with sclerosis
* Intravascular large B-cell lymphoma
* Immunoblastic B-cell lymphoma
* T-cell-rich B-cell lymphoma
* Anaplastic large B-cell lymphoma
* At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan
* No prior or active CNS lymphoma or AIDS-related lymphoma
* Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive
* Prior first and second-line therapy must have been combination chemotherapy
* Prior first-line chemotherapy regimen must have contained anthracycline
* Must have had at least a minor response to first-line therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 500/mm\^3 (unless due to lymphoma bone marrow involvement)
* Platelet count at least 50,000/mm\^3 (unless due to lymphoma bone marrow involvement)
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* ALT no greater than 4 times ULN
* Alkaline phosphatase no greater than 4 times ULN
Renal:
* Not specified
Neurologic:
* No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders)
* No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar)
* No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy
Other:
* No uncontrolled severe medical illness or infection
* HIV negative
* No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Radiotherapy
* No prior allogeneic bone marrow or peripheral blood stem cell transplantation
* At least 4 weeks since prior immunotherapy
* No concurrent biological agents
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent
Radiotherapy:
* Prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease
* Prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy to any disease site
Surgery:
* At least 4 weeks since prior major surgery except for diagnosis of lymphoma
* No concurrent surgical removal of any indicator lesion
Other:
* At least 4 weeks since prior alternative or investigational anticancer treatment
* No other concurrent systemic anticancer therapy
* No other concurrent investigational drug
* No concurrent phenytoin
* No concurrent hepatic drug metabolism inhibitors or inducers (cytochrome P450 isoenzymes in the CYP 3A subfamily)References
Publications (1)
- RESULTRodriguez MA, Pytlik R, Kozak T, Chhanabhai M, Gascoyne R, Lu B, Deitcher SR, Winter JN; Marqibo Investigators. Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma: report of the pivotal phase 2 study. Cancer. 2009 Aug 1;115(15):3475-82. doi: 10.1002/cncr.24359. PMID 19536896