SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

NCT00076349 | Completed Phase 2

• 1 other identifier: SDX-105-02
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 34

Brief Summary

SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.

Conditions

Non-Hodgkin's Lymphoma

Keywords

Non-Hodgkin's Lymphoma; NHL; Rituxan; Mantle Cell; mabs

Outcome Measures

Primary Outcomes (1)

• Determine the objective response rate (ORR = CR + PR) to a regimen of SDX-105 plus rituximab in patients with relapsed indolent or mantle cell non-Hodgkin's lymphoma

  4-6 months

Secondary Outcomes (1)

• • To characterize the safety profile of SDX-105 plus rituximab in this patient population • To determine the one-year and Kaplan-Meier estimates of progression-free survival (PFS) rates • To determine the median duration of response (DR)

  4-6 months

Study Arms (1)

1

EXPERIMENTAL

open-label, single arm, clinical trial of bendamustine (SDX-105) plus rituximab

Drug: bendamustine and rituximab

Interventions

bendamustine and rituximab DRUG

Patients will receive rituximab on the first day of a cycle at a dose of 375 mg/m2, followed on the second and third day of a cycle by SDX-105 (bendamustine) at a dose of 90 mg/m2/day of treatment. Four cycles are planned. Patients will receive a dose of rituximab alone 7 days prior to the first cycle of the combination and a dose of rituximab 28 days after the last cycle of the combination. If there is documented disease regression, a fifth and sixth cycle of SDX-105 plus rituximab may be administered.

1

Eligibility Criteria

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

You may qualify if:

• Documented B-Cell NHL or mantle cell lymphoma
• CD-20+ tumor
• Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
• Maximum of three prior chemotherapy regimens
• Age of at least 18 years at Screening Visit (Site specific requirement may differ)

You may not qualify if:

• Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
• Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
• Use of investigational agents within 28 days of study
• History of prior high dose chemotherapy with allogeneic stem cell support
• History of prior radioimmunotherapy

Sponsors & Collaborators

• Cephalon: lead

Study Sites (34)

Alaska Cancer Research and Education Center

Anchorage, Alaska, 99508, United States

Location

Bay Area Cancer Research Group

Concord, California, 94520, United States

Location

Wilshire Oncology Medical Group

La Verne, California, 91750, United States

Location

USC/Kenneth Norris Jr. Cancer Hospital and Research Institute

Los Angeles, California, 90033, United States

Location

San Diego Cancer Center

Vista, California, 92081, United States

Location

Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center

Stamford, Connecticut, 06902-3628, United States

Location

Georgetown University Medical Center - Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Pasco Hernando Oncology

New Port Richey, Florida, 34652, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31902, United States

Location

Suburban Hematology & Oncology Associates

Lawrenceville, Georgia, 30045, United States

Location

Georgia Oncology Partners Research and Education Foundation

Macon, Georgia, 31201, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Oncology and Hematology

Metairie, Louisiana, 70006-2921, United States

Location

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Beth Israel/Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Hubert H. Humphrey Cancer Center

Robbinsdale, Minnesota, 55422, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Arena Oncology Associates

Great Neck, New York, 11021, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology

Rochester, New York, 14623, United States

Location

ACORN - West Cancer Center

Memphis, Tennessee, 38120, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Univ. of Virginia Health System-Cancer Center Clinical Trials Office

Charlottesville, Virginia, 22908, United States

Location

Peter MacCallum Cancer Institute

East Melbourne, Victoria, 8006, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

St. Vincent's Hospital

Darlinghurst, NSW 2010, Australia

Location

Westmead Hospital

Westmead, NSW 2145, Australia

Location

Queen Elizabeth II Health Sciences Centre-Victoria General Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

The Royal Victoria Hospital Cancer Care Program Clinical Trials

Barrie, Ontario, L4M 6M2, Canada

Location

North Eastern Ontario Regional Cancer Center

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Hopital Notre-Dame Du Chum

Montreal, Quebec, H2L 4MI, Canada

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Bendamustine Hydrochloride; 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)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

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

Study Record Dates

• First Submitted: January 20, 2004
• First Posted: January 22, 2004
• Study Start: April 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: March 1, 2008
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

CA (5); AU (4); US (25)