Lymphoma, B-CellPhase 1NCT00271050
External Beam Radiotherapy and Zevalin for Management of Indolent B-Cell Non-Hodgkin's Lymphoma
A Phase 1 study testing external beam radiotherapy plus 90-Y ibritumomab tiuxetan in people with Lymphoma, B-Cell, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of the research study is to learn whether external beam radiation can be used as a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- external beam radiotherapy plus 90-Y ibritumomab tiuxetan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- B-cell non-Hodgkin's lymphoma of one of the following types as defined by the WHO classification:
- Small lymphocytic lymphoma/Chronic lymphocytic leukemia
- Nodal marginal zone B-cell lymphoma
- Extranodal marginal zone B-cell lymphoma
- Splenic marginal zone lymphoma
- Lymphoplasmacytic lymphoma
Show all 23Show fewer
- Follicular lymphoma
- Diffuse large B-cell lymphoma which has transformed from one of the previously listed types of lymphomas
- At least one site of lymphoma greater than or equal to 5 cm in any dimension
- Received at least one prior therapy
- Should show evidence of symptomatology as a result of their disease and/or evidence of progression of their disease.
- Measurable disease using Cheson criteria [23] for Non-Hodgkin's Lymphoma: a lymph node that is greater than 1 cm in its longest transverse diameter by CT scan should be considered compatible with involvement by NHL
- No anti-cancer therapy for four weeks (six weeks if rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
- An IRB-approved signed informed consent
- Age greater than or equal to 18
- Expected survival greater than or equal to 3 months
- Prestudy performance status of 0, 1, or 2 according to WHO
- Absolute neutrophil count ([segmented neutrophils + bands] x total WBC) > 1500/mm3 within two weeks prior to first dose of external beam radiation and also documented again two weeks prior to 90Y-ibritumomab tiuxetan treatment
- Platelet counts greater than or equal to 100,000 within two weeks prior to first dose of external beam radiation and also documented again two weeks prior to 90Y-ibritumomab tiuxetan treatment
- Bone marrow involvement by NHL less than 26% within six weeks of treatment with 90Y-ibritumomab tiuxetan
- Cellularity of bone marrow > 15% within 6 weeks of study
- Female patients who are not pregnant or lactating
- Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, abstinence is an acceptable method)
Who cannot join
- Prior radioimmunotherapy
- Presence of CNS lymphoma
- Absolute lymphocyte count ≥ 5000
- HIV or AIDS-related lymphoma
- Large pleural effusions or ascites
- Total bilirubin > 2.0 mg/dL
Show all 13Show fewer
- Serum creatinine > 2.0 mg/dL
- Patients who, in the opinion of their oncology team, have prior external beam radiation therapy to > 25% of active skeletal marrow (either involved field or regional)
- Patients who have received G-CSF or GM-CSF therapy within two weeks or pegfilgrastim within 4 weeks prior to treatment
- Serious nonmalignant disease or infection which, in the opinion of the investigator, would compromise other protocol objectives
- Major surgery, other than diagnostic surgery, within four weeks
- Pregnant women or women of child-bearing age who refuse pregnancy tests
- Patients who have had prior myeloablative autologous or allogenic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Conformal External Beam Radiotherapy in the Management of Patients With Bulky Disease Undergoing Y90-Ibritumomab Tiuxetan (Zevalin) Radio-immunotherapy for Indolent B-cell Non-Hodgkin's Lymphoma
The purpose of the research study is to learn whether external beam radiation can be used as a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin).
Read the detailed description
Non-Hodgkin's lymphomas (NHL) are a heterogeneous group of lymphoid malignancies that represent the 6th leading cause of cancer death and the 2nd fastest growing cancer in the United States. NHLs can be divided into two prognostic groups: aggressive and indolent lymphomas. Aggressive NHLs grow rapidly and present as disseminated disease in 70% of cases, yet can be cured in a significant number of patients with intensive combination chemotherapy regimens. Indolent (low-grade) NHLs are slow growing malignancies with long natural histories that are incurable when disseminated. Early stage low-grade NHL (stage I and II) has the potential for cure with radiotherapy, but only 10-20% of patients with low-grade NHL present with early stage disease. The vast majority of patients with low-grade NHL present with advanced disseminated disease. While indolent B-cell NHLs have initial sensitivity to chemotherapy and radiotherapy, they frequently relapse and become increasingly resistant to therapy with each successive relapse, eventually transforming to aggressive lymphomas in most patients. Fifty percent of patients presenting with advanced indolent NHL die within 5 years of their first relapse. Only modest improvement has been made in the last 25 years in increasing the survival of patients with indolent NHL with current median survival of 7-10 years.
Recent advances in the field of immunotherapy have proved to benefit patients with relapsed or refractory B-cell NHL. In 1997, rituximab became the first FDA-approved monoclonal antibody (mAb) for the treatment of cancer. Rituximab, a chimeric IgG1 kappa monoclonal antibody, specifically recognizes and binds to the CD20 antigen found on the cell surface of most normal B-cells and malignant B-cell lymphomas. Rituximab binds human complement and lyses B-cell lines through complement dependent cytotoxicity and antibody dependent cellular toxicity. A multi-center Phase II trial of 166 patients with relapsed indolent B-cell lymphoma treated with rituximab found an overall response in 50% of patients with 6% having a complete response and 44% having a partial response. Time to progression was a median of 13 months in patients who responded.
The introduction of radioimmunotherapy (RIT) has exploited the tumor cell targeting ability of mAbs to deliver doses of radiation to the tumor and limited surrounding tissue. This is especially useful in the treatment of NHL because lymphomas are highly sensitive to radiotherapy. 90Yttrium-ibritumomab tiuxetan (Zevalin) is a unique compound composed of the murine IgG1 anti-CD20 antibody ibritumomab, the linker chelator tiuxetan, and the radioisotope 90Y chelated via the linker. 90Y-ibritumomab tiuxetan can be described as providing a double hit therapeutic approach by having the CD20+ antibody properties of rituximab combined with radiation therapy.
90Yttrium-ibritumomab tiuxetan appears to be effective in the treatment of patients refractory to treatment with rituximab, but response rates decrease with increasing tumor size. 90Y-ibritumomab tiuxetan was approved by the FDA in 2002 for the treatment of patients with relapsed or refractory low-grade, follicular, or CD20+ transformed B-cell non-Hodgkin's lymphoma (NHL), and rituximab-refractory follicular NHL.
A preliminary survey of 20 patients treated with 90Y-ibritumomab tiuxetan at the Cleveland Clinic Foundation from 1998-2003 detailed patterns of NHL recurrence after treatment. The results of this survey were presented in part by Dr. Macklis at the 2004 annual meeting of the American Society of Therapeutic Radiation Oncology (ASTRO) in Atlanta and recently accepted for publication in the International Journal of Radiation Oncology, Biology, Physics. Based on preliminary data, a hypothesis can be made that some likely sites of disease recurrence/progression after RIT can be predicted by the volume of disease at a specific site prior to RIT. In short, pre-RIT bulky sites of disease are the most likely locations of disease recurrence after RIT followed by gross, but non-bulky, pre-RIT sites followed by entirely new sites. Based on this hypothesis, it might be beneficial to pre-treat bulky sites of NHL with external beam radiotherapy prior to RIT in order to promote a more durable response. Doses of external beam radiation required to consolidate these bulky disease sites are unclear.
In this study, we plan to utilize a dose of EBRT of 2,400cGy to bulky sites of disease followed by RIT. Though the combined effects of 2,400cGy of EBRT and RIT are likely to be well tolerated, such a combination has not been sufficiently studied. Therefore, the primary goal of this study is to determine if the combination of EBRT and RIT has an acceptable toxicity profile with regard to long-term myelosuppression and other non-hematological toxicities.
- Conditions
- Lymphoma, B-Cell
- Being tested
- external beam radiotherapy plus 90-Y ibritumomab tiuxetan
- Keywords
- non-Hodgkin's lymphoma, external beam radiotherapy (EBRT), radio-immunotherapy (RIT), Zevalin
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external beam radiotherapy plus 90-Y ibritumomab tiuxetanOther
Also called Zevalin
combination of EBRT followed by radioimmunotherapeutic 90-Y ibritumomab tiuxetan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: external beam radiotherapy plus 90-Y ibritumomab tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET and CT (w/oral and IV contrast)
Measured: 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Roger Macklis, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271050
- Sponsor's protocol ID
- IRB 7883
- Other IDs
- CCF IRB 7883, Case 1405
- Status last verified
- Dec 2010
- First submitted
- 28 Dec 2005
- Last updated
- 21 Dec 2010
- Results posted
- No
Publications
Fisher RI. Overview of non-Hodgkin's lymphoma: biology, staging, and treatment. Semin Oncol. 2003 Apr;30(2 Suppl 4):3-9. doi: 10.1053/sonc.2003.23797.
PubMed 12728402Dillman RO. Radiolabeled anti-CD20 monoclonal antibodies for the treatment of B-cell lymphoma. J Clin Oncol. 2002 Aug 15;20(16):3545-57. doi: 10.1200/JCO.2002.02.126. No abstract available.
PubMed 12177115Gustavsson A, Osterman B, Cavallin-Stahl E. A systematic overview of radiation therapy effects in non-Hodgkin's lymphoma. Acta Oncol. 2003;42(5-6):605-19. doi: 10.1080/02841860310014435.
PubMed 14596518Tobinai K. Rituximab and other emerging antibodies as molecular target-based therapy of lymphoma. Int J Clin Oncol. 2003 Aug;8(4):212-23. doi: 10.1007/s10147-003-0295-y.
PubMed 12955576Seymour JF. New treatment approaches to indolent non-Hodgkin's lymphoma. Semin Oncol. 2004 Feb;31(1 Suppl 2):27-32.
PubMed 15042532Forero A, Lobuglio AF. History of antibody therapy for non-Hodgkin's lymphoma. Semin Oncol. 2003 Dec;30(6 Suppl 17):1-5. doi: 10.1053/j.seminoncol.2003.10.002.
PubMed 14710396McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
PubMed 9704735Cheson BD. Radioimmunotherapy of non-Hodgkin lymphomas. Blood. 2003 Jan 15;101(2):391-8. doi: 10.1182/blood-2002-06-1793. Epub 2002 Sep 19.
PubMed 12393555Witzig TE, White CA, Wiseman GA, Gordon LI, Emmanouilides C, Raubitschek A, Janakiraman N, Gutheil J, Schilder RJ, Spies S, Silverman DH, Parker E, Grillo-Lopez AJ. Phase I/II trial of IDEC-Y2B8 radioimmunotherapy for treatment of relapsed or refractory CD20(+) B-cell non-Hodgkin's lymphoma. J Clin Oncol. 1999 Dec;17(12):3793-803. doi: 10.1200/JCO.1999.17.12.3793.
PubMed 10577851Witzig TE, Gordon LI, Cabanillas F, Czuczman MS, Emmanouilides C, Joyce R, Pohlman BL, Bartlett NL, Wiseman GA, Padre N, Grillo-Lopez AJ, Multani P, White CA. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2002 May 15;20(10):2453-63. doi: 10.1200/JCO.2002.11.076.
PubMed 12011122Justice TE, Martenson JA, Wiseman GA, Witzig TE. External beam radiation therapy after 90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory CD20+ non-Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys 2003; 57(Suppl 2):S287-8
O'Doherty MJ, Hoskin PJ. Positron emission tomography in the management of lymphomas: a summary. Eur J Nucl Med Mol Imaging. 2003 Jun;30 Suppl 1:S128-30. doi: 10.1007/s00259-003-1170-9. Epub 2003 Apr 12. No abstract available.
PubMed 12692689Blum RH, Seymour JF, Wirth A, MacManus M, Hicks RJ. Frequent impact of [18F]fluorodeoxyglucose positron emission tomography on the staging and management of patients with indolent non-Hodgkin's lymphoma. Clin Lymphoma. 2003 Jun;4(1):43-9. doi: 10.3816/clm.2003.n.013.
PubMed 12837154Kostakoglu L, Goldsmith SJ. Fluorine-18 fluorodeoxyglucose positron emission tomography in the staging and follow-up of lymphoma: is it time to shift gears? Eur J Nucl Med. 2000 Oct;27(10):1564-78. doi: 10.1007/s002590000340.
PubMed 11083548Leskinen-Kallio S, Ruotsalainen U, Nagren K, Teras M, Joensuu H. Uptake of carbon-11-methionine and fluorodeoxyglucose in non-Hodgkin's lymphoma: a PET study. J Nucl Med. 1991 Jun;32(6):1211-8.
PubMed 2045935
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Conformal External Beam Radiotherapy in the Management of Patients With Bulky Disease Undergoing Y90-Ibritumomab Tiuxetan (Zevalin) Radio-immunotherapy for Indolent B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00271050
- Acronym / sponsor ID
- IRB 7883
- Conditions
- Lymphoma, B-Cell
- Keywords
- non-Hodgkin's lymphoma, external beam radiotherapy (EBRT), radio-immunotherapy (RIT), Zevalin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research study is to learn whether external beam radiation can be used as a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin).
Detailed description
Non-Hodgkin's lymphomas (NHL) are a heterogeneous group of lymphoid malignancies that represent the 6th leading cause of cancer death and the 2nd fastest growing cancer in the United States. NHLs can be divided into two prognostic groups: aggressive and indolent lymphomas. Aggressive NHLs grow rapidly and present as disseminated disease in 70% of cases, yet can be cured in a significant number of patients with intensive combination chemotherapy regimens. Indolent (low-grade) NHLs are slow growing malignancies with long natural histories that are incurable when disseminated. Early stage low-grade NHL (stage I and II) has the potential for cure with radiotherapy, but only 10-20% of patients with low-grade NHL present with early stage disease. The vast majority of patients with low-grade NHL present with advanced disseminated disease. While indolent B-cell NHLs have initial sensitivity to chemotherapy and radiotherapy, they frequently relapse and become increasingly resistant to therapy with each successive relapse, eventually transforming to aggressive lymphomas in most patients. Fifty percent of patients presenting with advanced indolent NHL die within 5 years of their first relapse. Only modest improvement has been made in the last 25 years in increasing the survival of patients with indolent NHL with current median survival of 7-10 years.
Recent advances in the field of immunotherapy have proved to benefit patients with relapsed or refractory B-cell NHL. In 1997, rituximab became the first FDA-approved monoclonal antibody (mAb) for the treatment of cancer. Rituximab, a chimeric IgG1 kappa monoclonal antibody, specifically recognizes and binds to the CD20 antigen found on the cell surface of most normal B-cells and malignant B-cell lymphomas. Rituximab binds human complement and lyses B-cell lines through complement dependent cytotoxicity and antibody dependent cellular toxicity. A multi-center Phase II trial of 166 patients with relapsed indolent B-cell lymphoma treated with rituximab found an overall response in 50% of patients with 6% having a complete response and 44% having a partial response. Time to progression was a median of 13 months in patients who responded.
The introduction of radioimmunotherapy (RIT) has exploited the tumor cell targeting ability of mAbs to deliver doses of radiation to the tumor and limited surrounding tissue. This is especially useful in the treatment of NHL because lymphomas are highly sensitive to radiotherapy. 90Yttrium-ibritumomab tiuxetan (Zevalin) is a unique compound composed of the murine IgG1 anti-CD20 antibody ibritumomab, the linker chelator tiuxetan, and the radioisotope 90Y chelated via the linker. 90Y-ibritumomab tiuxetan can be described as providing a double hit therapeutic approach by having the CD20+ antibody properties of rituximab combined with radiation therapy.
90Yttrium-ibritumomab tiuxetan appears to be effective in the treatment of patients refractory to treatment with rituximab, but response rates decrease with increasing tumor size. 90Y-ibritumomab tiuxetan was approved by the FDA in 2002 for the treatment of patients with relapsed or refractory low-grade, follicular, or CD20+ transformed B-cell non-Hodgkin's lymphoma (NHL), and rituximab-refractory follicular NHL.
A preliminary survey of 20 patients treated with 90Y-ibritumomab tiuxetan at the Cleveland Clinic Foundation from 1998-2003 detailed patterns of NHL recurrence after treatment. The results of this survey were presented in part by Dr. Macklis at the 2004 annual meeting of the American Society of Therapeutic Radiation Oncology (ASTRO) in Atlanta and recently accepted for publication in the International Journal of Radiation Oncology, Biology, Physics. Based on preliminary data, a hypothesis can be made that some likely sites of disease recurrence/progression after RIT can be predicted by the volume of disease at a specific site prior to RIT. In short, pre-RIT bulky sites of disease are the most likely locations of disease recurrence after RIT followed by gross, but non-bulky, pre-RIT sites followed by entirely new sites. Based on this hypothesis, it might be beneficial to pre-treat bulky sites of NHL with external beam radiotherapy prior to RIT in order to promote a more durable response. Doses of external beam radiation required to consolidate these bulky disease sites are unclear.
In this study, we plan to utilize a dose of EBRT of 2,400cGy to bulky sites of disease followed by RIT. Though the combined effects of 2,400cGy of EBRT and RIT are likely to be well tolerated, such a combination has not been sufficiently studied. Therefore, the primary goal of this study is to determine if the combination of EBRT and RIT has an acceptable toxicity profile with regard to long-term myelosuppression and other non-hematological toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: external beam radiotherapy plus 90-Y ibritumomab tiuxetan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- B-cell non-Hodgkin's lymphoma of one of the following types as defined by the WHO classification:
- Small lymphocytic lymphoma/Chronic lymphocytic leukemia
- Nodal marginal zone B-cell lymphoma
- Extranodal marginal zone B-cell lymphoma
- Splenic marginal zone lymphoma
Key exclusion criteria (13 listed)
- Prior radioimmunotherapy
- Presence of CNS lymphoma
- Absolute lymphocyte count ≥ 5000
- HIV or AIDS-related lymphoma
- Large pleural effusions or ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external beam radiotherapy plus 90-Y ibritumomab tiuxetanAlso: Zevalincombination of EBRT followed by radioimmunotherapeutic 90-Y ibritumomab tiuxetan | Other | 1 |
Primary outcome
PET and CT (w/oral and IV contrast)
Time frame: 90 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
- Background: PubMed 12728402Fisher RI. Overview of non-Hodgkin's lymphoma: biology, staging, and treatment. Semin Oncol. 2003 Apr;30(2 Suppl 4):3-9. doi: 10.1053/sonc.2003.23797.
- Background: PubMed 12177115Dillman RO. Radiolabeled anti-CD20 monoclonal antibodies for the treatment of B-cell lymphoma. J Clin Oncol. 2002 Aug 15;20(16):3545-57. doi: 10.1200/JCO.2002.02.126. No abstract available.
- Background: PubMed 14596518Gustavsson A, Osterman B, Cavallin-Stahl E. A systematic overview of radiation therapy effects in non-Hodgkin's lymphoma. Acta Oncol. 2003;42(5-6):605-19. doi: 10.1080/02841860310014435.
- Background: PubMed 12955576Tobinai K. Rituximab and other emerging antibodies as molecular target-based therapy of lymphoma. Int J Clin Oncol. 2003 Aug;8(4):212-23. doi: 10.1007/s10147-003-0295-y.
- Background: PubMed 15042532Seymour JF. New treatment approaches to indolent non-Hodgkin's lymphoma. Semin Oncol. 2004 Feb;31(1 Suppl 2):27-32.
- Background: PubMed 14710396Forero A, Lobuglio AF. History of antibody therapy for non-Hodgkin's lymphoma. Semin Oncol. 2003 Dec;30(6 Suppl 17):1-5. doi: 10.1053/j.seminoncol.2003.10.002.
- Background: PubMed 9704735McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.
- Background: PubMed 12393555Cheson BD. Radioimmunotherapy of non-Hodgkin lymphomas. Blood. 2003 Jan 15;101(2):391-8. doi: 10.1182/blood-2002-06-1793. Epub 2002 Sep 19.
- Background: PubMed 10577851Witzig TE, White CA, Wiseman GA, Gordon LI, Emmanouilides C, Raubitschek A, Janakiraman N, Gutheil J, Schilder RJ, Spies S, Silverman DH, Parker E, Grillo-Lopez AJ. Phase I/II trial of IDEC-Y2B8 radioimmunotherapy for treatment of relapsed or refractory CD20(+) B-cell non-Hodgkin's lymphoma. J Clin Oncol. 1999 Dec;17(12):3793-803. doi: 10.1200/JCO.1999.17.12.3793.
- Background: PubMed 12011122Witzig TE, Gordon LI, Cabanillas F, Czuczman MS, Emmanouilides C, Joyce R, Pohlman BL, Bartlett NL, Wiseman GA, Padre N, Grillo-Lopez AJ, Multani P, White CA. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2002 May 15;20(10):2453-63. doi: 10.1200/JCO.2002.11.076.
- BackgroundJustice TE, Martenson JA, Wiseman GA, Witzig TE. External beam radiation therapy after 90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory CD20+ non-Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys 2003; 57(Suppl 2):S287-8
- Background: PubMed 12692689O'Doherty MJ, Hoskin PJ. Positron emission tomography in the management of lymphomas: a summary. Eur J Nucl Med Mol Imaging. 2003 Jun;30 Suppl 1:S128-30. doi: 10.1007/s00259-003-1170-9. Epub 2003 Apr 12. No abstract available.
Related trials for Lymphoma, B-Cell
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Macklis, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing external beam radiotherapy plus 90-Y ibritumomab tiuxetan in people with Lymphoma, B-Cell, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET and CT (w/oral and IV contrast) (time frame: 90 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271050, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2010.