Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma

NCT01497275 | Terminated Phase 2 Results DMC

• 1 other identifier: Pro00032517
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects (good and bad) of the combination of ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory mantle cell lymphoma. Zevalin is a monoclonal antibody that is combined with a radioactive substance and given with another monoclonal antibody called rituximab (Rituxan). It works by attaching to cancer cells and releasing radiation to damage those cells. Both Zevalin and Rituxan are given in this study, along with Velcade.

Conditions

Mantle-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response Rate (Complete Response + Partial Response)

  Disease will be assessed every 3 months. The Cheson criteria will be used to define response: Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy. Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.

  3 months

Secondary Outcomes (3)

• Number of Participants With Progression Free Survival

  6 months

• Overall Survival at 1 Year

  1 year

• Overall Survival at 5 Year

  5 year

Study Arms (1)

Zevalin + Velcade

EXPERIMENTAL

Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Other Names: Rituxan Velcade Zevalin Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.

Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan

Interventions

Rituximab, Bortezomib,Y90 ibritumomab tiuxetan DRUG

Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4mCi/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.

Also known as: Rituxan, Velcade, Zevalin

Zevalin + Velcade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.
• Age \> 18 years old
• Expected survival \>/= 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at initiation of study (Appendix I).
• Laboratory tests meet the levels specified in the protocol

You may not qualify if:

• 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 central nervous system (CNS) involvement
• Bone Marrow Involvement \>/= 25% within 30 days of initiation of study treatment
• Pregnant or breast feeding
• No patients who have received Granulocyte colony-stimulating factor (G-CSF) or Granulocyte macrophage colony-stimulating factor (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

Sponsors & Collaborators

• Duke University: lead
• Spectrum Pharmaceuticals, Inc: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab; Bortezomib; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was closed to enrollment due to the approval of new drugs for use in Mantle Cell Lymphoma. We were not able to enroll enough subjects to answer our study questions.

Results Point of Contact

• Title: Anne Beaven, MD
• Organization: Duke University Medical Center

anne.beaven@duke.edu

919-668-1211

Study Officials

• Anne Beaven, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: February 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 15, 2015
• Results First Posted: June 4, 2015

Record last verified: 2015-06

Locations

US (1)