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A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma

Phase 1/Phase 2
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma

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Trial Information

A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma

The primary efficacy endpoint was objective response rate, defined as the proportion of
patients with a response of CR + PR.

Duration of response, time to progression, and overall survival were analyzed. Descriptive
statistics were used for demographics, disease characteristics, treatment exposures,
efficacy, and safety variables.

Inclusion Criteria:

- Histologically-confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL), as
defined by the Revised European American Lymphoma/WHO classification. This included:
diffuse large B-cell, primary mediastinal large B-cell lymphoma with
sclerosis,intravascular large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell
rich B-cell lymphoma or anaplastic large B-cell lymphoma. In the US protocol only,
patients who had transformation from an indolent lymphoma and those who had mantle
cell lymphoma were eligible.

- Confirmation of CD20 expression on lymphoma cells.

- Eastern Cooperative Oncology Group (ECOG) ≤2.

- One or more prior chemotherapy regimens. Patients who had received prior
rituximab therapy as part of an induction chemotherapy regimen or who had a
previous response to rituximab as a single agent were eligible.

- Measurable disease in at least 1 site, which had not been previously irradiated.

Measurable disease was defined as at least 1 bidimensionally measurable lesion with
clearly defined margins that were ≥1.5 cm in the largest dimension determined by physical
examination or computed tomography (CT) scan.

- Total bilirubin and serum creatinine ≤2 times the ULN.

- Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.

- 18 years of age or older.

- Women of childbearing potential who were willing to use an acceptable method of
contraception throughout the course of the study.

Signed and dated informed consent form.

Exclusion Criteria:

- Known transformation from an indolent lymphoma (UK protocol only).

- Eligible for conventional or high-dose chemotherapy with curative intent.

- Radiotherapy, chemotherapy, immunotherapy, or corticosteroids (>10 mg/day of
prednisone or equivalent) within the past 4 weeks.

- Any previous malignancies with less than a 5-year complete remission interval, except
for curatively resected basal cell carcinoma or curatively resected in situ carcinoma
of the uterine cervix.

- History of or active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe
medical illness or infection.

- History of neurologic disorders unrelated to chemotherapy (including familial
neurologic diseases and acquired demyelinating disorders).

- Grade 3 or 4 sensory or motor neuropathy at screening related to prior chemotherapy.

- Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

- Pregnant or lactating women (women of childbearing potential underwent a pregnancy

- Allergy to vincristine, or other vinca alkaloids.

- Progressive disease while receiving or within 1 month of having received previous
rituximab therapy (US protocol only).

- Hypersensitivity to any component of rituximab or to murine proteins (UK protocol

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Description:

The primary efficacy endpoint was the objective response rate (ORR) defined as the proportion of patients whose best responses were complete response (CR) and partial response (PR) (ORR = CR + PR).

Outcome Time Frame:

Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks).

Safety Issue:


Principal Investigator

Lawrence Kaplan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

April 2005

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Mantle Cell Lymphoma
  • NHL
  • non-Hodgkin's lymphoma
  • diffuse large b-cell lymphoma
  • mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell



University of CaliforniaSan Francisco, California  94108