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A Phase I/II Study of VELCADE in Combination With Gemcitabine in Relapsed B-Cell Non-Hodgkin's Lymphoma

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase I/II Study of VELCADE in Combination With Gemcitabine in Relapsed B-Cell Non-Hodgkin's Lymphoma



I. To evaluate the safety and feasibility of combining VELCADE (bortezomib) with gemcitabine
(gemcitabine hydrochloride) in patients with recurrent lymphoma after standard therapy.

II. To define the maximum tolerated dose (MTD) of gemcitabine and Rituxan (rituximab)
administered in combination with VELCADE given on a 21-day (old schema - Schema I) or 28-day
(amended schema - Schema II) schedule.


I. To obtain preliminary data for response to this regimen in this patient population.

OUTLINE: This is a phase I, dose-escalation study of bortezomib and gemcitabine
hydrochloride followed by a phase II study.

Patients receive bortezomib intravenously (IV), gemcitabine hydrochloride IV over 3-4 hours,
and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in
the absence of disease progression or unacceptable toxicity. After completion of study
treatment, patients are followed up periodically.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed intermediate or high
grade B-cell Non-Hodgkin lymphoma with primary progressive or relapsed disease

- Patients may have had up to 4 prior chemo-and-or radiation therapy regiments,
including one autologous transplant based protocol; any prior therapy (chemotherapy
or radiation) must have been completed at least 4 weeks prior to start of this
protocol; for prior high-dose chemotherapy with stem cell transplant, a 6-week
interval is required; all side effects must have resolved

- Karnofsky performance status >= 60%

- Life expectancy of greater than 3 months

- Absolute neutrophil count >= 1,500 mm^3

- Platelets >= 50,000 mm^3

- Total bilirubin =< 1.5 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min
for creatinine levels above institutional normal (calculated or measured)

- Cardiac ejection fraction of > 40% by echocardiogram or multi gated acquisition
(MUGA) scan

- Have no serious or intercurrent medical illness

- Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study

- Male subject agrees to use an acceptable method for contraception for the duration of
the study

Exclusion Criteria:

- Patient has a platelet count of < 20 x 10^9/L with 7 days before enrollment

- Patient has an absolute neutrophil count of < 1.0 x 10^9/L within 7 days before

- Patient has a calculated or measured creatinine clearance of < 30 ml/min with 14 days
before enrollment

- Patient has >= Grade 2 peripheral neuropathy within 14 days before enrollment

- Patient has hypersensitivity to bortezomib, boron, or mannitol

- Female subject is pregnant or breastfeeding; confirmation that the subject is not
pregnant must be established by a negative serum beta-human chorionic gonadotropin
(beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not
required for postmenopausal or surgically sterilized women

- Patient has received other investigational drugs with 14 days before enrollment

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study

- Patients who have had more than 4 prior different chemotherapy regimens will be
excluded; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks
for autologous transplant regimens) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not have previously received VELCADE or gemcitabine

- Patients with active central nervous system (CNS) involvement are not eligible

- Human immunodeficiency virus (HIV)-positive patients receiving combination
anti-retroviral therapy

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

Type of Study:


Study Design:

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

Outcome Measure:

Safety and feasibility

Outcome Time Frame:

One month after completion of study treatment

Safety Issue:


Principal Investigator

Leslie Popplewell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • adult grade III lymphomatoid granulomatosis
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



City of Hope Medical CenterDuarte, California  91010
South Pasadena Cancer CenterSouth Pasadena, California  91030