Peripheral T-cell LymphomasEarly Phase 1NCT00704691
Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas
A Early Phase 1 study testing Lenalidomide in people with Peripheral T-cell Lymphomas and Adult T-cell Leukemia, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to: assess the effectiveness of lenalidomide for the treatment of patients with relapsed and or refractory peripheral T-cell lymphomas; and, assess the safety of lenalidomide. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral T-cell Lymphomas, Adult T-cell Leukemia, Adult T-cell Lymphoma
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2009
- Phase
- Early 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form.
- Age 19 and over at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with a confirmed diagnosis of peripheral T-cell lymphomas according to the World Health Organization (WHO) classification in the relapsed and/or refractory setting following prior anthracycline therapy. Subtypes of peripheral T-cell lymphomas which meet this criteria will include the following: adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma unspecified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, T/null cell, primary systemic type, subcutaneous panniculitis-like T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, and enteropathy-type T-cell lymphoma [33].
- Patients with a history of PTCL or cutaneous T-cell lymphoma (CTCL) with nodal/visceral disease in the relapsed and/or refractory setting following prior anthracycline therapy. This includes ≥ 3-6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent, CHOP-like regimen +/- radiation therapy. The definition for relapsed and refractory disease is provided in Appendix 5.
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
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- At least one measurable lesion according to the International Working Group response criteria for non-Hodgkin's lymphoma (see Appendix 5).
- ECOG performance status of less than or equal to 2 at study entry (see Appendix 2).
- Laboratory test results within these ranges:
- Absolute neutrophil count greater than or equal to 1.5 x 109/L
- Platelet count greater than or equal to 100 x 109/L (>70 x 10^9/L if bone marrow was involved)
- Serum creatinine less than or equal to 2.0 mg/dL
- Total bilirubin less than or equal to 1.5 mg/dL
- AST (SGOT) and ALT (SGPT) less than or equal to 2 x upper limit of normal (ULN) or less than or equal to 5 x ULN if hepatic metastases are present.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to therapy and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex* condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix 1: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- For patients who have latex allergies or whose partner(s) have latex allergies alternatives will be discussed.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Disease free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
- Able to take aspirin (81 mg) daily as prophylactic anticoagulation, if deemed necessary by investigator (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodorum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments within the past 28 days.
- Known positive for HIV or infectious hepatitis, type A, B or C.
- (Other) Precursor T-cell lymphomas (including immature T-cell lymphomas/leukemias) and cutaneous T-cell lymphomas (CTCL) with skin as the only organ of involvement
- Patients with prolonged QT interval on baseline EKG (>430 ms)
- Equal to greater than grade 3 peripheral neuropathy.
- Natural Killer (NK) cell lymphomas
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294 - 0104
About this study
Official title: Open-Label, One Arm Pilot Investigation of Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas
The purpose of this study is to:
- assess the effectiveness of lenalidomide for the treatment of patients with relapsed and or refractory peripheral T-cell lymphomas; and,
- assess the safety of lenalidomide.
There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of lenalidomide in the treatment of relapsed NHL's.
Read the detailed description
Peripheral T-cell lymphomas (PTCL's) represent a subgroup of Non-Hodgkin's lymphomas with poor prognostic features. Compared to aggressive B-cell lymphomas, PTCL's often present with more advanced disease and sustain less durable remissions following treatment with chemotherapy. With standard anthracycline-based regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), PTCLs achieve inferior 5-year overall survival rates of around 40% compared to aggressive B-cell lymphomas whose 5-year overall survival rates reach 50-60%. While several salvage regimens have been established for B-cell lymphomas with moderate success, the guidelines for patients with relapsed and/or refractory PTCL's are less clear. Several reports suggest that the immunomodulatory drugs (IMiDs®) have clinical activity in this setting. The aim of this phase 2 study is to evaluate the activity of lenalidomide in relapsed and/or refractory PTCL's.
- Conditions
- Peripheral T-cell Lymphomas, Adult T-cell Leukemia, Adult T-cell Lymphoma, Peripheral T-cell Lymphoma Unspecified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma
- Being tested
- Lenalidomide
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Leukemia-Lymphoma, Adult T-Cell, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Lenalidomide 25 mg as a daily oral dose days 1-21 followed by a 7 day rest period (28 day cycle) for 1-6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Not described Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate to lenalidomide (CR,PR and unconfirmed complete responses
Measured: Efficacy assessments every 8 weeks with a final assessment performed at the end of Cycle 6 (wk 24).
Secondary outcomes (1)
Toxicity of lenalidomide
Measured: Progressive disease during cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionDec 2009
Why it stopped: Closed due to futility with only 1 patient accrued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomasStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Foran, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704691
- Sponsor's protocol ID
- F071108004
- Other IDs
- UAB 0663
- Status last verified
- Apr 2012
- First submitted
- 21 Jun 2008
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, One Arm Pilot Investigation of Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00704691
- Acronym / sponsor ID
- F071108004
- Conditions
- Peripheral T-cell Lymphomas, Adult T-cell Leukemia, Adult T-cell Lymphoma, Peripheral T-cell Lymphoma Unspecified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to futility with only 1 patient accrued
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 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.
The purpose of this study is to:
- assess the effectiveness of lenalidomide for the treatment of patients with relapsed and or refractory peripheral T-cell lymphomas; and,
- assess the safety of lenalidomide.
There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of lenalidomide in the treatment of relapsed NHL's.
Detailed description
Peripheral T-cell lymphomas (PTCL's) represent a subgroup of Non-Hodgkin's lymphomas with poor prognostic features. Compared to aggressive B-cell lymphomas, PTCL's often present with more advanced disease and sustain less durable remissions following treatment with chemotherapy. With standard anthracycline-based regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), PTCLs achieve inferior 5-year overall survival rates of around 40% compared to aggressive B-cell lymphomas whose 5-year overall survival rates reach 50-60%. While several salvage regimens have been established for B-cell lymphomas with moderate success, the guidelines for patients with relapsed and/or refractory PTCL's are less clear. Several reports suggest that the immunomodulatory drugs (IMiDs®) have clinical activity in this setting. The aim of this phase 2 study is to evaluate the activity of lenalidomide in relapsed and/or refractory PTCL's.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: Lenalidomide |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Understand and voluntarily sign an informed consent form.
- Age 19 and over at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with a confirmed diagnosis of peripheral T-cell lymphomas according to the World Health Organization (WHO) classification in the relapsed and/or refractory setting following prior anthracycline therapy. Subtypes of peripheral T-cell lymphomas which meet this criteria will include the following: adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma unspecified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, T/null cell, primary systemic type, subcutaneous panniculitis-like T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, and enteropathy-type T-cell lymphoma [33].
- Patients with a history of PTCL or cutaneous T-cell lymphoma (CTCL) with nodal/visceral disease in the relapsed and/or refractory setting following prior anthracycline therapy. This includes ≥ 3-6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent, CHOP-like regimen +/- radiation therapy. The definition for relapsed and refractory disease is provided in Appendix 5.
Key exclusion criteria (13 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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 |
|---|---|---|
| LenalidomideLenalidomide 25 mg as a daily oral dose days 1-21 followed by a 7 day rest period (28 day cycle) for 1-6 cycles | Drug | Lenalidomide |
Primary outcome
Response Rate to lenalidomide (CR,PR and unconfirmed complete responses
Time frame: Efficacy assessments every 8 weeks with a final assessment performed at the end of Cycle 6 (wk 24).
1 secondary outcome
Toxicity of lenalidomide
Time frame: Progressive disease during cycle 1
Results and safety
The study was stopped early (reason given: Closed due to futility with only 1 patient accrued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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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.
James Foran, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lenalidomide in people with Peripheral T-cell Lymphomas and Adult T-cell Leukemia, run by University of Alabama at Birmingham 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 19 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: stopped early, as of the sponsor's last update on 20 Apr 2012. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Closed due to futility with only 1 patient accrued). Results are not available in the source record.
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?
Response Rate to lenalidomide (CR,PR and unconfirmed complete responses (time frame: Efficacy assessments every 8 weeks with a final assessment performed at the end of Cycle 6 (wk 24).). 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 20 Apr 2012; AzTrials last refreshed its copy on 26 Oct 2026.