LymphomaPhase 1NCT00562068
Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma
A Phase 1 study testing alemtuzumab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma and Small Intestine Cancer, run by Cancer Research UK at 5 sites in United Kingdom.
Trial summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Intestine Cancer
- What is being tested?
- alemtuzumab, cyclophosphamide and doxorubicin hydrochloride
- How many people
- 30 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- May 2007to May 2009
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes:
- PTCL not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma
- Intestinal T-cell lymphoma
- Bulky stage IA and stages IB-IV disease (Ann Arbor staging system)
- Expression of CD52 by the tumor
- Measurable or evaluable disease
- No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma
- No CNS involvement with non-Hodgkin lymphoma
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No presence of other serious, uncontrolled medical conditions
- No significant anthracycline-related cardiac impairment
- LVEF ≥ 50%
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 2 times normal value unless due to disease
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment
- No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
- No positive serology or non-consenting to test for any of the following:
- HIV
- Hepatitis B or C
- Human T-lymphotropic virus type 1 (HTLV-1)
PRIOR CONCURRENT THERAPY:
- No prior cytotoxic chemotherapy
- Prior radiotherapy may be allowed at the trial coordinator's discretion
- Concurrent consolidation radiotherapy may be given at the clinician's discretion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
Leeds General Infirmary
Leeds, England, LS1 3EX
Contact Person, 44-113-392-3766
- Recruiting
King's College Hospital
London, England, SE5 9RS
Contact Person, 44-20-3299-9000
- Recruiting
Royal Marsden - London
London, England, SW3 6JJ
Contact Person, 44-20-7352-8171
- Recruiting
Christie Hospital
Manchester, England, M20 4BX
Contact Person, 44-161-446-8565
- Recruiting
Torbay Hospital
Torbay Devon, England, TQ2 7AA
Contact Person, 44-180-365-5260
About this study
Official title: CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]
RATIONALE: Monoclonal antibodies, such as alemtuzumab, 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. 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 growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
- To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.
Secondary
- To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
- To monitor immune reconstitution after therapy.
- To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
- To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
- To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.
OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.
Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.
After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.
- Conditions
- Lymphoma, Small Intestine Cancer
- Being tested
- alemtuzumab, cyclophosphamide, doxorubicin hydrochloride, prednisolone, vincristine sulfate
- Keywords
- recurrent adult T-cell leukemia/lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, small intestine lymphoma, peripheral T-cell lymphoma
- Medical subject headings
- Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alemtuzumabBiological
cyclophosphamideDrug
prednisoloneDrug
polymerase chain reactionGenetic
flow cytometryOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate toxicity (incidence of infusion-related reactions)
Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
Secondary outcomes (6)
Disease response (remission rate [complete response and partial response])
Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
Relative dose intensity
Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
Epstein-Barr virus copy number (measured retrospectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Roderick Johnson, MD, Study chair, Leeds General Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562068
- Sponsor's protocol ID
- CDR0000576439
- Other IDs
- UCL-BRD/05/170, EU-20785, EUDRACT-2006-000365-11, CTA 21786/0201/001-0001, CRUK-UCL-BRD/05/170-CHOP-CAMPA, UCL-CHOP-CAMPATH
- Status last verified
- Nov 2008
- First submitted
- 20 Nov 2007
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Phillips EH, Devereux S, Radford J, Mir N, Adedayo T, Clifton-Hadley L, Johnson R. Toxicity and efficacy of alemtuzumab combined with CHOP for aggressive T-cell lymphoma: a phase 1 dose-escalation trial. Leuk Lymphoma. 2019 Sep;60(9):2291-2294. doi: 10.1080/10428194.2019.1576870. Epub 2019 Feb 18. No abstract available.
PubMed 30773077
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]
- ClinicalTrials.gov ID
- NCT00562068
- Acronym / sponsor ID
- CDR0000576439
- Conditions
- Lymphoma, Small Intestine Cancer
- Keywords
- recurrent adult T-cell leukemia/lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, small intestine lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2009 (estimated)
- First posted
- 21 Nov 2007 (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: Monoclonal antibodies, such as alemtuzumab, 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. 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 growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
- To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.
Secondary
- To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
- To monitor immune reconstitution after therapy.
- To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
- To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
- To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.
OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.
Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.
After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| alemtuzumab | Biological | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| prednisolone | Drug | – |
| vincristine sulfate | Drug | – |
| polymerase chain reaction | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Immediate toxicity (incidence of infusion-related reactions)
Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
6 secondary outcomes
Disease response (remission rate [complete response and partial response])
Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
Relative dose intensity
Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
Epstein-Barr virus copy number (measured retrospectively)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 30773077Phillips EH, Devereux S, Radford J, Mir N, Adedayo T, Clifton-Hadley L, Johnson R. Toxicity and efficacy of alemtuzumab combined with CHOP for aggressive T-cell lymphoma: a phase 1 dose-escalation trial. Leuk Lymphoma. 2019 Sep;60(9):2291-2294. doi: 10.1080/10428194.2019.1576870. Epub 2019 Feb 18. No abstract available.
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.
Roderick Johnson, MD study chair
Leeds General Infirmary
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alemtuzumab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma and Small Intestine Cancer, run by Cancer Research UK at 5 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 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
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?
Immediate toxicity (incidence of infusion-related reactions). The study lists 3 primary outcomes in all. 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 NCT00562068, which also lists 1 linked publication.
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 26 Aug 2013.