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A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas


Phase 1/Phase 2
15 Years
70 Years
Not Enrolling
Both
Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell

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Trial Information

A Phase I/II Study of Bortezomib Plus CHOP Every 2 Weeks in Patients With Advanced Stage Diffuse Large B-cell Lymphomas


Intended number of patients: 63 patients in total

- Phase I: 9 patients for 3 levels

- Phase II: 50 patients plus 3 patient from Phase I at MTD level

- Plus 4 patients: considering 5% follow-up loss rate

Study design and methodology:

For phase I, 9 patients; 3 levels of bortezomib (1.0, 1.3 and 1.6 mg/m2), 3 patients at each
dose level.

If escalation of bortezomib beyond 1.0 mg/m2 is not possible, the trial will be stopped.

For phase II, 53 patients (3 from phase I at MTD level); Reject when complete response rate
equal or less than 12/19 or 37/53 by Simon two-stage optimal phase II design.

Treatments:

- Bortezomib:

For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.

For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.

- CHOP2: cyclophosphamide 750mg/ m2 day 1, vincristine 1.4 mg/ m2 (max. 2 mg) day 1,
doxorubicin 50 mg/ m2 day 1, prednisolone 100 mg days 1-5, every 2 weeks.

- G-CSF: Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks.


Inclusion Criteria:



- Histologically confirmed DLBCL

- Age 70 years or less

- Previously untreated

- Performance status: ECOG 0-2

- Advanced stage: stage III, IV, or non-contiguous stage II

- Measurable disease: 1 cm or more by spiral CT

- Normal liver function

Exclusion Criteria:

- Platelet count less than 75,000/microL within 14 days before enrollment.

- Absolute neutrophil count of less than 1,500/microlL within 14 days before
enrollment.

- Cr more than 2.0 mg/dL and/or calculated or measured creatinine clearance less than
50 mL/min within 14 days before enrollment.

- Peripheral neuropathy of Grade 2 or worse within 14 days before enrollment.

- Hypersensitivity to bortezomib, boron or mannitol.

- Female subject is pregnant or breast-feeding.

- Other investigational drugs with 14 days before enrollment

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

- Uncontrolled or severe cardiovascular disease, including MI within 6 months of
enrolment, New York Heart Association (NYHA) Class III or IV heart failure,
uncontrolled angina, clinically significant pericardial disease, or cardiac
amyloidosis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients Who Achieved Complete Response

Outcome Description:

All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.

Outcome Time Frame:

14 weeks

Safety Issue:

No

Principal Investigator

Cheolwon Suh, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

AMC 2006-276

NCT ID:

NCT00379574

Start Date:

September 2006

Completion Date:

January 2011

Related Keywords:

  • Lymphoma, Large-Cell, Diffuse
  • Lymphoma, B-Cell
  • diffuse large B-cell lymphoma
  • Bortezomib
  • CHOP
  • Lenograstim
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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