LeukemiaPhase 2NCT00535873
Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older
A Phase 2 study testing Lenalidomide in people with Leukemia and CLL, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older. Secondary Objective: To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Leukemia, CLL, Chronic Lymphocytic Leukemia
- 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
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with untreated CLL or small lymphocytic lymphoma (SLL) with indication to treatment according to NCI Working Group guidelines.Patients that have received single agent rituximab will be allowed to participate in this study.
- Age 65 or older
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2.
- Adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to upper level of normal and as alanine aminotransferase (ALT) less or equal 2 upper limit of normal (ULN).
- Able to understand and sign Informed Consent after the investigational nature, study design, risks and benefits have been explained.
- Able to adhere to the study visit schedule and other protocol requirements.
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- Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
- Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence
- Continued from above. 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 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
- Men must agree to use a condom during sexual contact with a female of child bearing potential 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.
- All patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to Acetylsalicylic Acid (ASA) may use warfarin or low molecular weight heparin.
Who cannot join
- Known sensitivity to thalidomide or its derivatives.
- Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
- Known positivity for HIV or active hepatitis (B or C).
- A serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the Principal Investigator.
- Active cardiovascular disease as defined by the New York Heart Association Class 3 or 4.
- History of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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- Concurrent use of other chemotherapy agents.
- Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
- No known history of tuberculosis or recent exposure to tuberculosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older.
Primary Objective:
- To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.
Secondary Objective:
- To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older
Read the detailed description
The Study Drug:
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.
Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every morning at about the same time each day for 28 days. Twenty-eight (28) days is considered 1 cycle. The dose and schedule of lenalidomide may be adjusted up or down, depending on how the disease responds and the side effects you may experience. Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
Concomitant Medications:
Allopurinol will be prescribed for you during the first 14 days of treatment. This medication is taken by mouth and will help protect your kidney function.
Study Visits:
During this study, you will have blood (about 1 tablespoon each) drawn every other week until the best dose of lenalidomide has been found. Blood tests (about 1 tablespoon each) may be done more often if the dose of medication needs to be changed or if you experience intolerable side effects. Women who are able to have children must have a negative urine or blood (less than 1 teaspoon) pregnancy test 10 - 14 days and 24 hours before starting lenalidomide therapy, even if they have not had a menstrual period due to treatment of the disease or had as little as one menstrual period in the past 24 months. If you have regular or no menstrual cycles, you will then have pregnancy tests every week for the first 4 weeks, then every 4 weeks while taking lenalidomide, again when you have been taken off of lenalidomide therapy, and then 28 days after you have stopped taking lenalidomide. If you have irregular menstrual cycles, you will have pregnancy tests every week for the first 4 weeks, then every 2 weeks while taking lenalidomide, again when you have been taken off of lenalidomide therapy, and then 14 days and 28 days after you have stopped taking lenalidomide. Every month for the first 3 months, then at Months 6, 9, 12, and 15 you will have a physical exam to see how you are doing. After the 15-month visit, you will have a physical exam every 6 months.
After the first 3 months, and then every 6 months after that (unless your study doctor does not think it is necessary), you will have a bone marrow biopsy and aspirate performed to check the status of the disease.
Length of Study:
You may stay on this study for as long as you are benefitting. You will be taken off this study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Lenalidomide is FDA approved and commercially available. Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Its use in this study, for this disease, is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Lenalidomide
- Keywords
- Leukemia, CLL, chronic lymphocytic leukemia, SLL, small lymphocytic lymphoma, Untreated CLL, Lenalidomide, CC-5013, Revlimid, Oral
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid, CC-5013
Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes >1500/µL, platelets >100,000/µL, hemoglobin >11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets >100,000/µL or 50% improvement ; Hemoglobin >11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.
Measured: From 3 cycles (90 days) up to 6 cycles (approximately 180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Alessandra Ferrajoli, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535873
- Sponsor's protocol ID
- 2006-0715
- Status last verified
- Jul 2018
- First submitted
- 25 Sep 2007
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Takahashi K, Hu B, Wang F, Yan Y, Kim E, Vitale C, Patel KP, Strati P, Gumbs C, Little L, Tippen S, Song X, Zhang J, Jain N, Thompson P, Garcia-Manero G, Kantarjian H, Estrov Z, Do KA, Keating M, Burger JA, Wierda WG, Futreal PA, Ferrajoli A. Clinical implications of cancer gene mutations in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2018 Apr 19;131(16):1820-1832. doi: 10.1182/blood-2017-11-817296. Epub 2018 Jan 22.
PubMed 29358183Strati P, Keating MJ, Wierda WG, Badoux XC, Calin S, Reuben JM, O'Brien S, Kornblau SM, Kantarjian HM, Gao H, Ferrajoli A. Lenalidomide induces long-lasting responses in elderly patients with chronic lymphocytic leukemia. Blood. 2013 Aug 1;122(5):734-7. doi: 10.1182/blood-2013-04-495341. Epub 2013 Jun 25.
PubMed 23801633Badoux XC, Keating MJ, Wen S, Lee BN, Sivina M, Reuben J, Wierda WG, O'Brien SM, Faderl S, Kornblau SM, Burger JA, Ferrajoli A. Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood. 2011 Sep 29;118(13):3489-98. doi: 10.1182/blood-2011-03-339077. Epub 2011 Jul 1.
PubMed 21725050
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older.
- ClinicalTrials.gov ID
- NCT00535873
- Acronym / sponsor ID
- 2006-0715
- Keywords
- Leukemia, CLL, chronic lymphocytic leukemia, SLL, small lymphocytic lymphoma, Untreated CLL, Lenalidomide, CC-5013
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Oct 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 2 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.
Secondary Objective:
- To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older
Detailed description
The Study Drug:
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.
Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every morning at about the same time each day for 28 days. Twenty-eight (28) days is considered 1 cycle. The dose and schedule of lenalidomide may be adjusted up or down, depending on how the disease responds and the side effects you may experience. Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
Concomitant Medications:
Allopurinol will be prescribed for you during the first 14 days of treatment. This medication is taken by mouth and will help protect your kidney function.
Study Visits:
During this study, you will have blood (about 1 tablespoon each) drawn every other week until the best dose of lenalidomide has been found. Blood tests (about 1 tablespoon each) may be done more often if the dose of medication needs to be changed or if you experience intolerable side effects. Women who are able to have children must have a negative urine or blood (less than 1 teaspoon) pregnancy test 10 - 14 days and 24 hours before starting lenalidomide therapy, even if they have not had a menstrual period due to treatment of the disease or had as little as one menstrual period in the past 24 months. If you have regular or no menstrual cycles, you will then have pregnancy tests every week for the first 4 weeks, then every 4 weeks while taking lenalidomide, again when you have been taken off of lenalidomide therapy, and then 28 days after you have stopped taking lenalidomide. If you have irregular menstrual cycles, you will have pregnancy tests every week for the first 4 weeks, then every 2 weeks while taking lenalidomide, again when you have been taken off of lenalidomide therapy, and then 14 days and 28 days after you have stopped taking lenalidomide. Every month for the first 3 months, then at Months 6, 9, 12, and 15 you will have a physical exam to see how you are doing. After the 15-month visit, you will have a physical exam every 6 months.
After the first 3 months, and then every 6 months after that (unless your study doctor does not think it is necessary), you will have a bone marrow biopsy and aspirate performed to check the status of the disease.
Length of Study:
You may stay on this study for as long as you are benefitting. You will be taken off this study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Lenalidomide is FDA approved and commercially available. Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Its use in this study, for this disease, is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
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: LenalidomideLenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Patients with untreated CLL or small lymphocytic lymphoma (SLL) with indication to treatment according to NCI Working Group guidelines.Patients that have received single agent rituximab will be allowed to participate in this study.
- Age 65 or older
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2.
- Adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to upper level of normal and as alanine aminotransferase (ALT) less or equal 2 upper limit of normal (ULN).
- Able to understand and sign Informed Consent after the investigational nature, study design, risks and benefits have been explained.
Key exclusion criteria (9 listed)
- Known sensitivity to thalidomide or its derivatives.
- Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
- Known positivity for HIV or active hepatitis (B or C).
- A serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the Principal Investigator.
- Active cardiovascular disease as defined by the New York Heart Association Class 3 or 4.
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 |
|---|---|---|
| LenalidomideAlso: Revlimid, CC-5013Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle. | Drug | Lenalidomide |
Primary outcome
Overall Response Rate (ORR)
Time frame: From 3 cycles (90 days) up to 6 cycles (approximately 180 days)
ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes >1500/µL, platelets >100,000/µL, hemoglobin >11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets >100,000/µL or 50% improvement ; Hemoglobin >11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29358183Takahashi K, Hu B, Wang F, Yan Y, Kim E, Vitale C, Patel KP, Strati P, Gumbs C, Little L, Tippen S, Song X, Zhang J, Jain N, Thompson P, Garcia-Manero G, Kantarjian H, Estrov Z, Do KA, Keating M, Burger JA, Wierda WG, Futreal PA, Ferrajoli A. Clinical implications of cancer gene mutations in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2018 Apr 19;131(16):1820-1832. doi: 10.1182/blood-2017-11-817296. Epub 2018 Jan 22.
- Derived from this study: PubMed 23801633Strati P, Keating MJ, Wierda WG, Badoux XC, Calin S, Reuben JM, O'Brien S, Kornblau SM, Kantarjian HM, Gao H, Ferrajoli A. Lenalidomide induces long-lasting responses in elderly patients with chronic lymphocytic leukemia. Blood. 2013 Aug 1;122(5):734-7. doi: 10.1182/blood-2013-04-495341. Epub 2013 Jun 25.
- Derived from this study: PubMed 21725050Badoux XC, Keating MJ, Wen S, Lee BN, Sivina M, Reuben J, Wierda WG, O'Brien SM, Faderl S, Kornblau SM, Burger JA, Ferrajoli A. Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood. 2011 Sep 29;118(13):3489-98. doi: 10.1182/blood-2011-03-339077. Epub 2011 Jul 1.
- M.D. Anderson Cancer Center's websiteLink provided by the sponsor.
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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.
Alessandra Ferrajoli, M.D. principal investigator
M.D. Anderson Cancer Center
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 Lenalidomide in people with Leukemia and CLL, run by M.D. Anderson Cancer Center 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 21 Aug 2018. 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?
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?
Yes. Results are posted in the registry (first posted 2 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) (time frame: From 3 cycles (90 days) up to 6 cycles (approximately 180 days)). 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 NCT00535873, which also lists 3 linked publications.
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 21 Aug 2018.