LymphomaNCT00689845
Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma
A study testing bleomycin sulfate, filgrastim and rituximab in people with Lymphoma, run by University Hospital Southampton NHS Foundation Trust at 8 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bleomycin sulfate, filgrastim and rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Jun 2007to not given
- Phase
- Interventional
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed primary mediastinal diffuse large B-cell lymphoma
- CD20-positive disease
- Any stage of disease
- Must have a dominant mass within the anterior mediastinum
PATIENT CHARACTERISTICS:
- ANC ≥ 1.5 x 10^9/L (unless due to lymphoma)
- Platelets ≥ 100 x 10^9/L (unless due to lymphoma)
- WBC ≥ 3.0 x 10^9/L (unless due to lymphoma)
- Serum creatinine ≤ 2 times upper limit of normal (ULN) (unless due to lymphoma)
- AST/ALT ≤ 2.5 times ULN (unless due to lymphoma)
- Total bilirubin ≤ 2.5 times ULN (unless due to lymphoma)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be fit to receive chemotherapy with curative intent
- No evidence of clinically significant cardiac disease* within the past 12 months, including any of the following:
- Symptomatic ventricular arrhythmias
- Congestive heart failure
- Myocardial infarction NOTE: * Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- No known HIV infection
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Able and willing to give informed consent and to undergo staging, including PET scanning
PRIOR CONCURRENT THERAPY:
- No prior treatment for lymphoma
- Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites, 8 recruiting
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Contact Person, 44-113-206-6400
- Recruiting
St. George's Hospital
London, England, SW17 0QT
Contact Person, 44-208-725-2425, rpetteng@sghms.ac.uk
- Recruiting
Saint Bartholomew's Hospital
London
Contact Person, 44-207-796-3979, silvia.montoto@cancer.org.uk
- Recruiting
Christie Hospital
Manchester, England, M20 4BX
Contact Person, 44-845-226-3000
- Recruiting
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Contact Person, 44-1923-826-111
- Recruiting
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Contact Person, 44-114-226-5007, b.w.hancock@sheffield.ac.uk
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Contact Person, 44-238-079-6186, johnsonp@soton.ac.uk
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-208-661-3279, david.cunningham@rmh.nhs.uk
About this study
Official title: A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells.
PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- To systematically analyze the phenotype and molecular characteristics in patients with primary mediastinal diffuse large B-cell lymphoma.
- To determine the PET response rate following chemoimmunotherapy in these patients.
Secondary
- To obtain data, on a nonrandomized basis, regarding the outcomes of treatment using different chemoimmunotherapy regimens and using or omitting mediastinal radiotherapy, depending upon the practice of the participating institutions.
- To analyze progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive any one of the following standard chemoimmunotherapy regimens.
- Cohort 1 (R-CHOP-21): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Cohort 2 (R-CHOP-14): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- Cohort 3 (R-MACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 4 (R-VACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 5 (R-ACVBP): Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
Patients with an International Prognostic Index score of 4 or greater or disease in close proximity to the spinal cord or cerebral meninges may receive prophylactic treatment to the CNS according to local protocol.
Beginning 8 weeks after completion of chemoimmunotherapy, patients undergo radiotherapy to the original tumor volume according to local protocol.
Fresh or fixed tissue from prior biopsy is obtained if possible. Samples are analyzed for CD3, CD20, CD30, CD15, CD10, Bcl-6, Bcl-2, MAL protein (if available), and Ki-67 via immunohistochemistry.
After completion of study treatment, patients are followed periodically.
- Conditions
- Lymphoma
- Being tested
- bleomycin sulfate, filgrastim, rituximab, cyclophosphamide, cytarabine
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
Given IV
filgrastimBiological
Given subcutaneously
rituximabBiological
given IV
cyclophosphamideDrug
Given IV
cytarabineDrug
Given subcutaneously
Given IV
etoposide phosphateDrug
Given IV
ifosfamideDrug
Given IV
methotrexateDrug
Given IV
prednisoloneDrug
Given orally
prednisoneDrug
Given orally
Given IV
vindesineDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisolone; Drug: vincristine sulfate |
| Cohort 2 | Experimental | Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: filgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisolone; Drug: vincristine sulfate |
| Cohort 3 | Experimental | Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper. Receives: Biological: bleomycin sulfate; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: methotrexate; Drug: prednisolone; Drug: vincristine sulfate |
| Cohort 4 | Experimental | Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper. Receives: Biological: bleomycin sulfate; Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide phosphate; Drug: prednisolone; Drug: vincristine sulfate |
| Cohort 5 | Experimental | Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B. Receives: Biological: bleomycin sulfate; Biological: filgrastim; Biological: rituximab; Drug: cyclophosphamide; Drug: cytarabine; Drug: doxorubicin hydrochloride; Drug: etoposide phosphate; Drug: ifosfamide; Drug: methotrexate; Drug: prednisone; Drug: vindesine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate on PET scanning at the completion of chemoimmunotherapy
Secondary outcomes (3)
Progression-free survival
Death
Survival time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Peter Johnson, MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689845
- Sponsor's protocol ID
- CDR0000588011
- Other IDs
- USCTU-IELSG-26-RHM-CAN0546, EU-20818, EudraCT 2006-005794-22, USCTU-07/Q1704/68
- Status last verified
- Jul 2009
- First submitted
- 3 Jun 2008
- Last updated
- 8 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26)
- ClinicalTrials.gov ID
- NCT00689845
- Acronym / sponsor ID
- CDR0000588011
- Conditions
- Lymphoma
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2007
- First posted
- 4 Jun 2008 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells.
PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- To systematically analyze the phenotype and molecular characteristics in patients with primary mediastinal diffuse large B-cell lymphoma.
- To determine the PET response rate following chemoimmunotherapy in these patients.
Secondary
- To obtain data, on a nonrandomized basis, regarding the outcomes of treatment using different chemoimmunotherapy regimens and using or omitting mediastinal radiotherapy, depending upon the practice of the participating institutions.
- To analyze progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive any one of the following standard chemoimmunotherapy regimens.
- Cohort 1 (R-CHOP-21): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Cohort 2 (R-CHOP-14): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- Cohort 3 (R-MACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 4 (R-VACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 5 (R-ACVBP): Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
Patients with an International Prognostic Index score of 4 or greater or disease in close proximity to the spinal cord or cerebral meninges may receive prophylactic treatment to the CNS according to local protocol.
Beginning 8 weeks after completion of chemoimmunotherapy, patients undergo radiotherapy to the original tumor volume according to local protocol.
Fresh or fixed tissue from prior biopsy is obtained if possible. Samples are analyzed for CD3, CD20, CD30, CD15, CD10, Bcl-6, Bcl-2, MAL protein (if available), and Ki-67 via immunohistochemistry.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: rituximab, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisolone, Drug: vincristine sulfatePatients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort 2 | Experimental | Biological: filgrastim, Biological: rituximab, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisolone, Drug: vincristine sulfatePatients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. |
| Cohort 3 | Experimental | Biological: bleomycin sulfate, Biological: rituximab, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: methotrexate, Drug: prednisolone, Drug: vincristine sulfatePatients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper. |
| Cohort 4 | Experimental | Biological: bleomycin sulfate, Biological: rituximab, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: etoposide phosphate, Drug: prednisolone, Drug: vincristine sulfatePatients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper. |
| Cohort 5 | Experimental | Biological: bleomycin sulfate, Biological: filgrastim, Biological: rituximab, Drug: cyclophosphamide, Drug: cytarabine, Drug: doxorubicin hydrochloride, Drug: etoposide phosphate, Drug: ifosfamide, Drug: methotrexate, Drug: prednisone, Drug: vindesinePatients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bleomycin sulfateGiven IV | Biological | Cohort 3, Cohort 4, Cohort 5 |
| filgrastimGiven subcutaneously | Biological | Cohort 2, Cohort 5 |
| rituximabgiven IV | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| cyclophosphamideGiven IV | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| cytarabineGiven subcutaneously | Drug | Cohort 5 |
| doxorubicin hydrochlorideGiven IV | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| etoposide phosphateGiven IV | Drug | Cohort 4, Cohort 5 |
| ifosfamideGiven IV | Drug | Cohort 5 |
| methotrexateGiven IV | Drug | Cohort 3, Cohort 5 |
| prednisoloneGiven orally | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| prednisoneGiven orally | Drug | Cohort 5 |
| vincristine sulfateGiven IV | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| vindesineGiven IV | Drug | Cohort 5 |
Primary outcome
Complete response rate on PET scanning at the completion of chemoimmunotherapy
3 secondary outcomes
Progression-free survival
Death
Survival time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
Related trials for Lymphoma
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
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Peter Johnson, MD principal investigator
University Hospital Southampton NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bleomycin sulfate, filgrastim and rituximab in people with Lymphoma, run by University Hospital Southampton NHS Foundation Trust at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate on PET scanning at the completion of chemoimmunotherapy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2009.