LymphomaPhase 2NCT00958854
Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma
A Phase 2 study testing cyclophosphamide, fludarabine phosphate and thalidomide in people with Lymphoma, run by Cancer Research UK at 1 site in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- cyclophosphamide, fludarabine phosphate and thalidomide
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2006to Mar 2012
- Phase
- Phase 2
- 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:
- Newly diagnosed angioimmunoblastic T-cell lymphoma
- Measurable disease (i.e., anatomically assessable)
PATIENT CHARACTERISTICS:
- WHO/ECOG performance status 0-2
- Serum creatinine ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception before, during, and after study treatment
- No known seropositivity for hepatitis B virus, hepatitis C virus, or HIV
- No active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for angioimmunoblastic T-cell lymphoma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cancer Research UK and University College London Cancer Trials Centre
Exeter, England, EX2 5DW
Claudius Rudin, MD, 44-1392-402-850
About this study
Official title: Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.
Secondary
- Assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide.
- Determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide.
- Assess the progression-free and overall survival of these patients.
- Develop a detailed pathological description of the disease at presentation and at relapse.
- Assess the number of circulating clonal T cells at presentation and during thalidomide treatment.
- Screen for possible etiological viruses at presentation.
- Evaluate the evolution of EBV viral load during follow-up.
OUTLINE: This is a multicenter study.
Patients receive oral or IV fludarabine and oral or IV cyclophosphamide once daily on days 1-3. Courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months.
Lymph nodes, marrow, and peripheral blood will be collected periodically for research studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
- Conditions
- Lymphoma
- Being tested
- cyclophosphamide, fludarabine phosphate, thalidomide, laboratory biomarker analysis
- Keywords
- angioimmunoblastic T-cell lymphoma
- Medical subject headings
- Lymphoma, Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
thalidomideDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after chemotherapy with fludarabine and cyclophosphamide
Secondary outcomes (3)
Incremental response rate to thalidomide treatment
Toxicity according to the NCI CTCAE v.3.0
Progression-free and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJan 2006
- Primary completionMar 2012 (estimated)
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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Claudius Rudin, MD, Principal investigator, Royal Devon and Exeter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958854
- Sponsor's protocol ID
- CDR0000644123
- Other IDs
- CRUK-UCL-AITL, EUDRACT-2005-003931-40, EU-20947
- Status last verified
- Aug 2009
- First submitted
- 12 Aug 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
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
- Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT00958854
- Acronym / sponsor ID
- CDR0000644123
- Conditions
- Lymphoma
- Keywords
- angioimmunoblastic T-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2012 (estimated)
- First posted
- 13 Aug 2009 (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, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.
Secondary
- Assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide.
- Determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide.
- Assess the progression-free and overall survival of these patients.
- Develop a detailed pathological description of the disease at presentation and at relapse.
- Assess the number of circulating clonal T cells at presentation and during thalidomide treatment.
- Screen for possible etiological viruses at presentation.
- Evaluate the evolution of EBV viral load during follow-up.
OUTLINE: This is a multicenter study.
Patients receive oral or IV fludarabine and oral or IV cyclophosphamide once daily on days 1-3. Courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months.
Lymph nodes, marrow, and peripheral blood will be collected periodically for research studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| fludarabine phosphate | Drug | – |
| thalidomide | Drug | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Response rate after chemotherapy with fludarabine and cyclophosphamide
3 secondary outcomes
Incremental response rate to thalidomide treatment
Toxicity according to the NCI CTCAE v.3.0
Progression-free and overall survival
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.
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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.
Cancer Research UK and University College London Cancer Trials Centre
Exeter, United Kingdom
Claudius Rudin, MD principal investigator
Royal Devon and Exeter Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide, fludarabine phosphate and thalidomide in people with Lymphoma, run by Cancer Research UK at 1 site 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response rate after chemotherapy with fludarabine and cyclophosphamide. 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 26 Aug 2013.