LymphomaPhase 2GemBexNCT00660231
Gemcitabine and Bexarotene in Treating Patients With Progressive or Refractory Stage IB, Stage II, Stage III, or Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
A Phase 2 study testing bexarotene and gemcitabine hydrochloride in people with Lymphoma, run by University College, London at 7 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bexarotene and gemcitabine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Mar 2008to Jan 2014
- 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:
- Histologically confirmed cutaneous T-cell lymphoma (CTCL) including its variants (e.g., mycosis fungoides and Sézary syndrome)
- CTCL stage IB, IIA, IIB, III or IVA disease
- No visceral involvement (i.e., stage IVB disease)
- Lymphadenopathy is allowed
- Patients must have developed progressive disease after receiving or have been refractory to at least 1 course of prior standard, systemic, skin-directed therapy (e.g., interferon, chemotherapy, or denileukin diftitox [Ontak®])
- No CD30 + (Ki1+ve) anaplastic large cell lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 6 months
- Hemoglobin ≥ 9.0 g/dL (transfusions and/or erythropoietin are allowed)
- ANC > 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.25 times upper limit of normal (ULN)
- AST and ALT ≤ 2 times ULN
- Serum creatinine ≤ 2 times ULN
- No clinically significant active infection
- No uncontrolled diabetes mellitus
- No excessive alcohol consumption
- No biliary tract disease
- No history of pancreatitis
- HIV negative
- Hepatitis B and C negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer, cervical epithelial neoplasm CIN1, or carcinoma in situ
- No other significant medical or psychiatric condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since any prior investigational agent
- More than 2 weeks since prior topical steroids or more than 4 weeks since prior systemic steroids
- Local radiotherapy may be given to isolated symptomatic tumour nodules that require immediate treatment for up to 2 weeks prior to study drugs
- No prior treatment with bexarotene (Targretin®)
- No concurrent anticancer therapy
- No concurrent investigational agent
- No concurrent drug therapy with other medications that can elevate triglycerides or cause pancreatic toxicity (e.g., gemfibrozil)
- No concurrent warfarin
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Saint Bartholomew's Hospital
London, England, EC1A 7BE
St. Thomas' Hospital
London, England, SE1 7EH
Christie Hospital
Manchester, England, M20 4BX
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Cornwall Hospital
Truro, England, TR1 3LJ
About this study
Official title: A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see how well it works in treating patients with progressive or refractory stage IB, stage II, stage III, or stage IV cutaneous T-cell non-Hodgkin lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Confirm the feasibility and efficacy of the combination of gemcitabine hydrochloride and bexarotene in patients with cutaneous T-cell lymphoma whose disease is no longer controlled by skin-directed therapy and who have had at least one prior systemic therapy.
Secondary
- Determine the rate of objective disease control as defined by complete response (CR), clinical complete response (CCR), partial response (PR), and stable disease (SD) for 6 months as determined by the Objective Primary Disease Response Evaluation Criteria (OPDREC).
- Evaluate the duration and durability of objective disease response (CR, CCR and PR) as determined by OPDREC criteria.
- Evaluate time to objective disease response.
- Determine the safety of this combination in terms of adverse events, clinical laboratory data, physical examinations, rate of neutropenic fever and sepsis, blood transfusions, and treatment compliance.
- Determine the time to objective disease progression.
- Determine the time to treatment failure.
- Determine change from baseline in Severity-Weighted Assessment Tool (SWAT) value, Erythroderma SWAT value, Pruritus Visual Analogue Scale, and ECOG performance status.
- Determine proportion of disease control, response, and progression as determined by RECIST criteria.
- Evaluate the proportion of patients with clearing of Sézary cells from the blood and bone marrow.
- Measure changes in patient assessed Quality of Life using Skindex 29 and EORTC QLQ-30.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral bexarotene daily on days 1-21. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses of study therapy, patients with responding disease receive oral bexarotene alone daily until disease progression or treatment no longer tolerated.
Patients complete a quality of life questionnaire at baseline, during study therapy, and after completion of study treatment.
After completion of study treatment, patients are followed every 2 months for up to 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
- Conditions
- Lymphoma
- Being tested
- bexarotene, gemcitabine hydrochloride
- Keywords
- recurrent mycosis fungoides/Sezary syndrome, stage IB mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage IB cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bexaroteneDrug
Also called Targretin
Bexarotene daily p.o. 150mg/sq m during week 1 and 2, then 300mg/sq m if tolerated.
Gemcitabine i.v. 1000mg/sq m day 1 and day 8 of four 21 day cycles.
| Study group | Role | What they receive |
|---|---|---|
| GemBex | Experimental | Gemcitabine days 1 and 8 of a 3 week cycle (4 cycles total - 12 weeks) Bexarotene daily: in combination with Gemcitabine during first 12 weeks, then Bexarotene maintenance until disease progression. Receives: Drug: bexarotene; Drug: gemcitabine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of objective response
Measured: at 24 weeks
Secondary outcomes (2)
Duration and durability of objective disease response
Time from first date of treatment to the first date of diagnosis of progressive disease
Measured: up to 5 years after treatment start
Assessment of quality of life
Measured: up to 5 years after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionJan 2014
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.
- More trials run by University College, LondonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Illidge, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660231
- Sponsor's protocol ID
- UCL/06/009
- Other IDs
- CRUK-UCL-GEMBEX, EU-20841, EUDRACT 2006-000591-33
- Acronym
- GemBex
- Status last verified
- Dec 2014
- First submitted
- 16 Apr 2008
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine and Bexarotene (Gembex) in the Treatment of Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00660231
- Acronym / sponsor ID
- GemBex / UCL/06/009
- Conditions
- Lymphoma
- Keywords
- recurrent mycosis fungoides/Sezary syndrome, stage IB mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage IB cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Apr 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, such as gemcitabine and bexarotene, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying giving gemcitabine together with bexarotene to see how well it works in treating patients with progressive or refractory stage IB, stage II, stage III, or stage IV cutaneous T-cell non-Hodgkin lymphoma.
Detailed description
OBJECTIVES:
Primary
- Confirm the feasibility and efficacy of the combination of gemcitabine hydrochloride and bexarotene in patients with cutaneous T-cell lymphoma whose disease is no longer controlled by skin-directed therapy and who have had at least one prior systemic therapy.
Secondary
- Determine the rate of objective disease control as defined by complete response (CR), clinical complete response (CCR), partial response (PR), and stable disease (SD) for 6 months as determined by the Objective Primary Disease Response Evaluation Criteria (OPDREC).
- Evaluate the duration and durability of objective disease response (CR, CCR and PR) as determined by OPDREC criteria.
- Evaluate time to objective disease response.
- Determine the safety of this combination in terms of adverse events, clinical laboratory data, physical examinations, rate of neutropenic fever and sepsis, blood transfusions, and treatment compliance.
- Determine the time to objective disease progression.
- Determine the time to treatment failure.
- Determine change from baseline in Severity-Weighted Assessment Tool (SWAT) value, Erythroderma SWAT value, Pruritus Visual Analogue Scale, and ECOG performance status.
- Determine proportion of disease control, response, and progression as determined by RECIST criteria.
- Evaluate the proportion of patients with clearing of Sézary cells from the blood and bone marrow.
- Measure changes in patient assessed Quality of Life using Skindex 29 and EORTC QLQ-30.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine hydrochloride IV on days 1 and 8 and oral bexarotene daily on days 1-21. Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses of study therapy, patients with responding disease receive oral bexarotene alone daily until disease progression or treatment no longer tolerated.
Patients complete a quality of life questionnaire at baseline, during study therapy, and after completion of study treatment.
After completion of study treatment, patients are followed every 2 months for up to 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GemBex | Experimental | Drug: bexarotene, Drug: gemcitabine hydrochlorideGemcitabine days 1 and 8 of a 3 week cycle (4 cycles total - 12 weeks) Bexarotene daily: in combination with Gemcitabine during first 12 weeks, then Bexarotene maintenance until disease progression. |
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 |
|---|---|---|
| bexaroteneAlso: TargretinBexarotene daily p.o. 150mg/sq m during week 1 and 2, then 300mg/sq m if tolerated. | Drug | GemBex |
| gemcitabine hydrochlorideGemcitabine i.v. 1000mg/sq m day 1 and day 8 of four 21 day cycles. | Drug | GemBex |
Primary outcome
Rate of objective response
Time frame: at 24 weeks
2 secondary outcomes
Duration and durability of objective disease response
Time frame: up to 5 years after treatment start
Assessment of quality of life
Time frame: up to 5 years after treatment start
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 3 Dec 2014.
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.
Tim Illidge principal investigator
The Christie NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bexarotene and gemcitabine hydrochloride in people with Lymphoma, run by University College, London at 7 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: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
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?
Rate of objective response (time frame: at 24 weeks). 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 3 Dec 2014.