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A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mantle-Cell Lymphoma

Thank you

Trial Information

A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma


Inclusion Criteria:



- Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.

- Age > 18 years old

- Expected survival >/= 3 months

- ECOG performance status of 0, 1 or 2 at initiation of study (Appendix I).

- Laboratory tests meet the levels specified in the protocol

Exclusion Criteria:

- Patients must not have received chemotherapy, radiation or surgical resection of
malignancy within 3 weeks of study initiation. However, if they have received
nitrosurea or mitomycin C then they should not be enrolled in the study until 6 weeks
after therapy was last received.

- No limitations to number of prior therapies

- No prior radioimmunotherapy (RIT)

- Prior bortezomib is allowed

- Patient must be fully recovered from all toxicities associated with prior surgery,
radiation treatment, chemotherapy or immunotherapy.

- No active, serious infection or medical or psychiatric illness likely to interfere
with participation in this clinic trial

- No known HIV infection

- No active CNS involvement

- Bone Marrow Involvement >/= 25% within 30 days of initiation of study treatment

- Pregnant or breast feeding

- No patients who have received G-CSF or GM-CSF within the 14 days prior to initiating
protocol

- No patient who has had major surgery within the four weeks prior to initiating
protocol therapy

- No patients with pleural effusion or significant ascites

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate (Complete response + Partial response)

Outcome Description:

Disease will be assessed every 3 months until month 24. The Cheson criteria will be used to define response.

Outcome Time Frame:

at 24 months of treatment

Safety Issue:

No

Principal Investigator

Anne Beaven, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00032517

NCT ID:

NCT01497275

Start Date:

February 2012

Completion Date:

March 2020

Related Keywords:

  • Mantle-Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Duke University Medical CenterDurham, North Carolina  27710