Fludarabine, Velcade and Rituximab for Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

NCT01186458 | Terminated Phase 2 Results DMC

• 1 other identifier: HOG LYM08-134
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to determine the effectiveness of fludarabine, Velcade, and rituximab treatment regimen in patients with relapsed or refractory follicular non-Hodgkin lymphoma.

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.

  6 months

Secondary Outcomes (3)

• Survival

  6 months

• Toxicity

  6 months

• Biologic Interaction

  6 months

Study Arms (1)

Fludarabine, Velcade and Rituximab

EXPERIMENTAL

Fludarabine, Velcade and Rituximab

Drug: Fludarabine; Drug: Velcade; Drug: Rituximab

Interventions

Fludarabine DRUG

Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.

Fludarabine, Velcade and Rituximab

Velcade DRUG

Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.

Fludarabine, Velcade and Rituximab

Rituximab DRUG

Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.

Fludarabine, Velcade and Rituximab

Eligibility Criteria

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

You may qualify if:

• Must have histologically confirmed Follicular Non-Hodgkin Lymphoma (Grade I, II, or IIIa)
• Must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥2 cm with conventional techniques or as \>1 cm with spiral CT scan) and obtained by imaging within 30 days prior to registration for protocol therapy.
• Must have received at least one prior therapeutic regimen, but no more than three prior regimens of conventional cytotoxic therapy. NOTE: Prior recipients of stem cell transplantation will be included, with the preparative cytoreductive and high-dose therapies counted collectively as one prior therapy.
• Must be off all cytotoxic chemotherapy for at least four weeks prior to registration for protocol therapy (6 weeks for BCNU or mitomycin C).
• Patients are allowed to have received one course of prior radioimmunotherapy (RIT: either tositumomab or ibritumomab). NOTE: Radioimmunotherapy must be completed at least 12 weeks prior to registration for protocol therapy with recovery to baseline of ANC and platelets.
• Prior fludarabine, Velcade or rituximab is allowed as long as therapy is completed at least 30 days prior to registration for protocol therapy. Patients may be refractory (defined as not responding or demonstrating progressive disease in \<6 months) to prior rituximab. Patients may not be refractory to prior fludarabine or Velcade.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed and for 30 days following protocol therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to prior to registration for protocol therapy. NOTE: Patients are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (no menses for at least 12 months).
• Females must not be breastfeeding.
• Males must agree to use an acceptable method of contraception for the duration of the study.

You may not qualify if:

• No current active CNS metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 7 days prior to registration for protocol therapy. NOTE: Patients with treated brain metastasis must be off steroids or on tapering or stable doses of steroids and have completed radiation at least 30 days prior to registration for protocol therapy.
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason ≤ grade 6 prostate cancers, or other cancer for which the subject has been disease-free for at least 3 years.
• No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
• Prior radiation therapy is allowed to \< 25% of the bone marrow. NOTE: No radiation therapy within 30 days prior to registration for protocol therapy.
• No clinically significant infections as judged by the treating investigator.
• No active HIV, hepatitis B or hepatitic C infection.
• No cerebrovascular accident (CVA) within 6 months of study enrollment.
• No psychiatric illness/social situations that would limit compliance with study requirements.
• No history of hypersensitivity to Velcade, boron or mannitol.
• No peripheral neuropathy grade \> 1.

Sponsors & Collaborators

• Hoosier Cancer Research Network: lead
• Genentech, Inc.: collaborator
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (11)

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Community Regional Cancer Center

Indianapolis, Indiana, 46256, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Virtua Health Cancer Program

Mount Holly, New Jersey, 08060, United States

Location

South Jersey Health Care

Vineland, New Jersey, 08360, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Case Comprehensive Cancer Center - University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Reading Hospital Regional Cancer Center

West Reading, Pennsylvania, 19611, United States

Location

Related Links

• Hoosier Oncology Group Homepage

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

fludarabine; Bortezomib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This trial was terminated after accruing four subjects to do slow accrual. Sufficient data was not collected to complete the primary objective.

Results Point of Contact

• Title: Clinical Data Coordinator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Shivani Srivastava, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 19, 2010
• First Posted: August 23, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 24, 2016
• Results First Posted: October 24, 2016

Record last verified: 2016-08

Locations

US (11)