- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005592
Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Multicenter, Open-Label, Trial to Evaluate the Efficacy and Safety of IDEC-Y2B8 Radioimmunotherapy of Relapsed or Refractory Low-Grade or Follicular Transformed B-Cell Non-Hodgkin's Lymphoma
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.
OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8 immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven relapsed or refractory, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL) Prior rituximab allowed if no response achieved CD20-positive B-cells in lymph nodes or bone marrow required for small lymphocytic or transformed NHL Less than 25% of bone marrow cellularity in lymphoma cells No impaired bone marrow reserve, as indicated by one or more of the following: Prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescue Platelet count less than 100,000/mm3 Hypocellular bone marrow (no more than 15% cellularity) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, or erythroid) History of failed stem cell collection Not eligible for any active ibritumomab tiuxetan investigative protocols No CNS lymphoma, AIDS-related lymphoma, or chronic lymphocytic leukemia No pleural effusion A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: See Disease Characteristics Absolute neutrophil count at least 1,500/mm3 Lymphocyte count no greater than 5,000/mm3 (for small lymphocytic lymphoma) Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study HIV negative No serious nonmalignant disease or infection that would preclude study No antimurine antibody reactivity
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 6 weeks since prior rituximab At least 3 weeks since prior immunotherapy and recovered No prior radioimmunotherapy At least 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: See Biologic therapy At least 3 weeks since prior radiotherapy and recovered No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional) Surgery: At least 4 weeks since prior major surgery (other than diagnostic) and recovered Other: At least 3 weeks since prior anticancer therapy and recovered At least 8 weeks since prior phase II drugs and recovered No other concurrent myelosuppressive antineoplastic agents No other concurrent antineoplastic therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8
For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given.
If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).
|
IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells.
It is used to deliver radiation therapy to kill lymphoma cells.
This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
Other Names:
Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells.
It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine.
It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion.
The physician will then be able to see and evaluate the location and concentration of the antibody in the body.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols.
Time Frame: up to 4.25 years
|
up to 4.25 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To add to the overall efficacy and safety experience in this indication.
Time Frame: up to 4.25 years
|
up to 4.25 years
|
Collaborators and Investigators
Investigators
- Study Chair: Mansoor N Saleh, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Antibodies, Monoclonal
Other Study ID Numbers
- CDR0000067697
- UAB-9930 (OTHER: cancer center department study number)
- IDEC-106-98 (OTHER: IDEC study sponsor protocol number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma
-
Marcela V. Maus, M.D.,Ph.D.RecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Non-Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Non-hodgkin Lymphoma | High-grade B-cell Lymphoma | Grade 3b Follicular Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
-
Novartis PharmaceuticalsBristol-Myers SquibbRecruitingNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaUnited States, Germany, Italy, Korea, Republic of, Spain, Singapore, China, Japan, Australia
-
IGM Biosciences, Inc.ADC Therapeutics S.A.Active, not recruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCLUnited States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
-
Zhejiang UniversityShanghai First Song Therapeutics Co., LtdNot yet recruitingHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Gray Zone Lymphoma | NK/T Cell Lymphoma | Peripheral T Cell Lymphoma, Unspecified | Mediastinal B-Cell Diffuse Large Cell LymphomaChina
-
Massachusetts General HospitalTG TherapeuticsActive, not recruitingLymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2United States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin LymphomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
SymBio PharmaceuticalsCompletedFollicular Lymphoma | Non-Hodgkin's Lymphoma | Lymphoma, Large Cell | Diffuse, Mantle Cell Lymphoma, Lymphoma | Large B-Cell, DiffuseJapan, Korea, Republic of
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Diffuse Large B-cell LymphomaUnited States
-
Novartis PharmaceuticalsCompletedDiffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular LymphomaUnited States, Belgium, Germany, France, Italy, Korea, Republic of, Spain, Turkey
Clinical Trials on 90-Y-ibritumomab tiuxetan
-
Spectrum Pharmaceuticals, IncBayerCompleted
-
BayerCompletedLymphoma, Follicular | Non-Hodgkin LymphomaBelgium
-
BayerCompletedLymphoma, Non-HodgkinBelgium, France, Spain, Italy, Canada, Switzerland, Netherlands, United Kingdom, Portugal, Germany, Sweden, Denmark, Norway
-
Alnylam PharmaceuticalsActive, not recruitingPrimary Hyperoxaluria Type 1 (PH1) | Primary HyperoxaluriaUnited States, France, United Kingdom, Israel, Germany
-
Alnylam PharmaceuticalsApproved for marketingPrimary HyperoxaluriaBelgium
-
Alnylam PharmaceuticalsActive, not recruitingPrimary Hyperoxaluria Type 1 | Primary HyperoxaluriaUnited States, Italy, France, Lebanon, Belgium, Netherlands, Israel, United Arab Emirates, Australia, Jordan, Turkey
-
Chulalongkorn UniversityBayerTerminatedDiffuse Large B-cell LymphomaThailand
-
Northwestern UniversityRobert H. Lurie Cancer CenterTerminated
-
National Cancer Institute (NCI)CompletedRecurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Waldenström Macroglobulinemia | Post-transplant Lymphoproliferative Disorder | Stage III Adult Burkitt Lymphoma | Stage III Adult Diffuse Large Cell Lymphoma | Stage IV Adult Burkitt Lymphoma | Stage IV Adult Diffuse...United States
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed