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A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma


- Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in
patients with relapsed mantle cell lymphoma.

- Determine the toxicity of this regimen in these patients.

- Determine the time to progression and duration of response in patients treated with
this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over
30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter until relapse/progression.

Inclusion Criteria


- Histologically confirmed mantle cell lymphoma

- Relapsed disease

- Not refractory to prior therapy

- Must have received 1-3 prior systemic chemotherapy regimens AND has had no
disease progression while receiving chemotherapy or within 1 month of last dose
of most recent therapy

- Clinically and/or radiologically documented disease

- At least 1 site of disease must be bidimensionally measurable by CT scan or MRI
with ≥ 1 lesion meeting 1 of the following criteria:

- Lymph nodes ≥ 1.5 cm x 1.5 cm by spiral CT scan

- Non-nodal lesion ≥ 1 cm x 1 cm by MRI, CT scan, or physical exam

- No nonmeasurable disease only

- No preexisting ascites or pleural effusion ≥ grade 2

- No known CNS involvement by lymphoma


- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 75,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- AST or ALT ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- LVEF ≥ 45% by echocardiogram or MUGA

- No history of allergic reactions attributed to compounds containing boron or mannitol

- No preexisting edema ≥ grade 2

- No preexisting neuropathy (sensory and/or pain) ≥ grade 2

- No preexisting shortness of breath ≥ grade 2

- No history of other malignancies, except adequately treated nonmelanoma skin cancer,
curatively treated in situ cancer of the cervix, or other solid tumors curatively
treated with no evidence of disease for ≥ 5 years

- No other serious illness or medical condition that would preclude compliance with
study requirements, including any of the following:

- Serious uncontrolled infection

- Uncontrolled or severe cardiovascular disease, including any of the following:

- Myocardial infarction within the past 6 months

- New York Heart Association class III-IV heart failure

- Uncontrolled angina

- Clinically significant pericardial disease

- Cardiac amyloidosis

- Significant neurological disorder


- See Disease Characteristics

- At least 6 weeks since prior chemotherapy

- No prior radioactive monoclonal antibody therapy

- No prior bortezomib

- No prior investigational therapy (except for flavopiridol)

- No prior radiotherapy to > 25% of functioning bone marrow

- At least 4 weeks since prior radiotherapy and recovered

- Low-dose, nonmyelosuppressive radiotherapy may be allowed

- At least 2 weeks since prior major surgery

- No other concurrent anticancer therapy

- No concurrent corticosteroids

- No other concurrent cytotoxic chemotherapy

- No other concurrent investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumor response (overall response rate with 95% confidence interval)

Outcome Time Frame:

each cycle

Safety Issue:


Principal Investigator

C. Tom Kouroukis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

June 2006

Completion Date:

June 2011

Related Keywords:

  • Lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell