B-cell Chronic Lymphocytic LeukemiaPhase 1TAILNCT01604031
Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide
A Phase 1 study testing B-CLL Vaccine and Lenalidomide in people with B-cell Chronic Lymphocytic Leukemia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a research study to determine the safety and effectiveness of using special cells that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in combination with a drug called Lenalidomide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Chronic Lymphocytic Leukemia
- What is being tested?
- B-CLL Vaccine and Lenalidomide
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ELIGIBILITY FOR BLAST COLLECTION (procurement):
- Patients with B-CLL (not in Richter's transformation) with measurable disease.
- Procurement consent signed and faxed to Research Coordinator
- HIV negative (can be pending at this time)
- ELIGIBILITY FOR VACCINE AND LENALIDOMIDE ADMINISTRATION (protocol entry):
- Manipulated B-CLL cells available (at least 6 injections)
Show all 24Show fewer
- Patients with B-CLL (not in Richter's transformation) with measurable disease
- Patients must have a life expectancy of at least 10 weeks.
- Patients must be less than 75 years old
- Patients must have ECOG performance status of 0-2.
- Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study:
- Absolute neutrophil count (ANC) of greater than or equal to 500/microL
- Absolute lymphocyte count (ALC) greater than or equal 200/microL,
- Hemoglobin greater than or equal 8 g/dL
- Platelet count greater than or equal 50,000/microL.
- Patients must be willing to practice appropriate birth control methods during the study and for 28 days after their participation in the treatment portion of the study is concluded.
- Patients must have adequate liver function:
- Total bilirubin less than or equal to 1.5 mg/dl, SGOT less than or equal to 3 times normal
- Normal prothrombin time
- Patients must have adequate renal function (creatinine clearance greater than 50 ml/min).
- Patients provide informed consent.
- Patient must not have received treatment with other investigational agents within the last 4 weeks.
- All study participants (treatment) must be registered in the REMS® Program and be willing to comply with the requirements of REMS® .
- Note: A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Who cannot join
- EXCLUSION CRITERIA FOR VACCINE ADMINISTRATION (protocol entry):
- Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole).
- Pregnant or lactating
- Suffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)
- Receiving immunosuppressive drugs.
- Received systemic steroids within 30 days of study enrollment
Show all 10Show fewer
- Autologous hematopoietic stem cell transplant or fludarabine chemotherapy within 6 months of study enrollment
- History of allogeneic stem cell transplant
- Patients with congestive heart failure or significant arrhythmia
- Known hypersensitivity to thalidomide or lenalidomide.
Trial locations and contacts
1 site in 1 country.
About this study
This is a research study to determine the safety and effectiveness of using special cells that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in combination with a drug called Lenalidomide.
To do this, the investigators will put a special gene into cancer cells that have been taken from the subject. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the subject's immune system kill cancer cells. Additionally, the investigators will stimulate the cancer cells with normal embryonic fibroblasts (cells that develop into normal connective tissues in the body) so that they will make another natural protein called CD40 ligand (CD40L). Some of these cells will then be put back into the subject's body with the goal that they will act like a vaccine and stimulate the immune system to attack the CLL cells.
Read more
The investigators have already conducted a study similar to this in other subjects with CLL. In those subjects the investigators saw some changes in the subject's immune system that might indicate that the modified cells were helping their immune system fight the cancer. However, in most of the subjects this change in the immune system went away after the injections were stopped. The investigators think that this may be due to a high level of cells called T regulatory cells. T regulatory cells are part of the immune system and prevent excessive reactions from other cells in the body. Studies have shown that reducing T regulatory cells allows the body to fight the cancer for a longer period of time.
Recent studies have shown that using Lenalidomide helps the body reduce T regulatory cells. Using Lenalidomide along with the injections (shots) might help the body fight the cancer for a longer period of time. Lenalidomide is also called Revlimid.
In this study the investigators want to see if they can make the change in the immune system last longer by giving Lenalidomide before and at the same time as the vaccine. The investigators hope that this might produce a better response directed at the CLL cells. Subjects will receive injections for about a year
Read the detailed description
Previously, some of the cancer cells were taken from the subject's body and separated in the laboratory and a specially produced human virus (adenovirus) that carries the IL-2 gene was put into the cells. Adenovirus is a common virus found in human respiratory systems. In its normal state, it can reproduce and cause a respiratory infection. Respiratory illnesses caused by adenovirus infections range from the common cold to pneumonia, croup and bronchitis. This adenovirus has been changed in the laboratory so that it is not likely to reproduce or cause an infection once it is in the body. The gene transfer method used in this study tries to add copies of the IL2 gene that increases the immune response against a tumor.
The rest of the cancer cells have been stimulated to express on their surface a substance called the human CD40L. These substances (IL-2 and CD40L), already naturally present in the body, are meant to help the immune system fight the cancer.
At the point that the doctor feels the subject should begin treatment on this protocol, the treatment will be as follows:
The subject will begin taking Allopurinol by mouth at 300 mg and will continue taking Allopurinol daily for 14 days. Allopurinol is also called Zyloprim and it will be taken to prevent tumor lysis syndrome. Tumor lysis syndrome can be a serious condition that occurs sometimes when cancer treatment is started. Tumor lysis syndrome can cause other medical problems.
Two days after Allopurinol was started, the subject will begin taking Lenalidomide. The Lenalidomide dose will be 5 mg taken by mouth daily. The subject should swallow the capsules whole with water at the same time each day and should not break, chew or open the capsules. Females of childbearing potential who are caring for the subject should not touch the lenalidomide capsules or bottles without gloves. If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up. If more than the prescribed dose is taken of lenalidomide and the subject feels poorly, s/he should seek emergency medical care and tell the study staff right away. The subject will get 1 cycle of drug per month. A max of a 28-day supply of the drug will be provided at one time. If the subject has bad side effects the doctor may tell him/her not to take the lenalidomide for a short time period or may be removed from the study. Otherwise, the subject will continue daily dosing with Lenalidomide for approximately 1 year, until four weeks after the final vaccine.
Four weeks after the subject starts the Lenalidomide s/he will start to receive his/her vaccines. The vaccine will be injected under the skin (also called subcutaneously). Normally the subject will have the shots as an outpatient (no overnight stay in the hospital will be required). S/he will receive the first five (5) shots at 2 week intervals. S/he will then receive eleven (11) shots at 4 weekly intervals. In total, the subject may receive up to sixteen (16) shots over a period of one year. As with the Lenalidomide if the subject has bad side effects s/he may not receive his/her vaccines for a short period of time or may be removed from the study. Otherwise, the subject will receive the vaccines on the schedule as specified earlier in this paragraph. These shots must be given at Houston Methodist Hospital.
Following these injections, the doctor will follow the subject for 1 year after the last shot to see how the subject is doing.
TESTS DURING AND AFTER EXPERIMENTAL TREATMENT:
A complete history and physical examination is necessary before the subject can be enrolled in the study. A physical examination will also be performed each time s/he receives a shot of the modified cells. The place on the subject's body where s/he had received the shots will be examined during the physical exam.
Research Blood Samples:
Blood will be taken from a tube placed into the vein (IV). We will take blood samples at the following time points: at study entry, week 0 when the subject starts Lenalidomide, weeks 2, 4, 6, 8, 10 and 16 and then every 4 weeks until week 60. The last blood sample will be at one year after the last shot. We will do this to make sure that the Lenalidomide is working correctly and to study how the modified cells are working in the body.
The amount of blood that will be obtained each time is approximately 2-3 tablespoonfuls, which is considered to be a safe amount. If the subject has a central line (an IV line that has been placed in a large blood vessel that is meant to be used for long periods of time), the blood will be taken from it, so that extra "sticks" should not be needed. Additional office visits may be necessary to obtain this blood. The maximum total amount of blood to be collected from the subject is 40-60 tablespoons.
Other tests: If the subject is a woman who can get pregnant, she will have pregnancy counseling and urine tests as long as she is taking lenalidomide.
In order to participate in this study, the subject must register into and follow the requirements of the Revlimid REMS® program of Celgene Corporation (the company that supplies Lenalidomide). This program provides education and counseling on the risks of fetal exposure, blood clots and reduced blood counts that can occur when taking Lenalidomide. The subject will be required to receive counseling every 28 days during treatment with lenalidomide, follow the pregnancy testing and birth control requirements of the program that are appropriate for him/her and take telephone surveys regarding your compliance with the program. Participating in the Revlimid REMS® program is a study requirement.
- Conditions
- B-cell Chronic Lymphocytic Leukemia
- Being tested
- B-CLL Vaccine, Lenalidomide
- Keywords
- B-CLL, vaccine, Lenalidomide, CTL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-CLL VaccineBiological
Patients will receive a fixed dose (2X10^7) of IL-2 secreting B-cells together with (2X10^7) of hCD40L expressing B-cells. Patients will receive doses of vaccine at 2 week intervals for 5 doses. Barring adverse events, an additional 11 doses of vaccine will be given, at 4 weekly intervals beginning on week 12 for a total period of one year or 16 vaccinations in total.
LenalidomideDrug
Also called Revlimid
Subjects will begin lenalidomide 5 mg orally daily on day zero and will continue daily dosing until week 60 (4 weeks after the final dose of vaccine).
| Study group | Role | What they receive |
|---|---|---|
| B-CLL vaccine | Experimental | Patients will receive doses of vaccine at 2 week intervals for 5 doses and at 4 week intervals for doses 6-16. The injection will be performed subcutaneously in the deltoid region of the upper arm. Receives: Biological: B-CLL Vaccine; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events after Lenalidomide with B-CLL cell vaccine
To assess the safety of administration of lenalidomide combined with prolonged administration of CD40L expressing and IL-2 secreting B-CLL cells (B-CLL vaccine).
Measured: week 60
Changes in SP tumor cell population from pre-vaccine to four weeks post-vaccination
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden and on the side population of tumor cells.
Measured: week 4
Changes in SP tumor cell population from pre-vaccine to eight weeks post vaccination
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden and the side population of tumor cells.
Measured: week 8
Number of patients with a tumor response post vaccination
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden.
Measured: 4 weeks
Number of patients with a tumor response post vaccination
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Martha Mims, Baylor College of Medicine
- Investigators
- Martha Mims, MD, Principal investigator, Baylor College of MedicineMalcolm Brenner, MB, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604031
- Sponsor's protocol ID
- H-30087 TAIL
- Acronym
- TAIL
- Status last verified
- Feb 2016
- First submitted
- 4 May 2012
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide
- ClinicalTrials.gov ID
- NCT01604031
- Acronym / sponsor ID
- TAIL / H-30087 TAIL
- Conditions
- B-cell Chronic Lymphocytic Leukemia
- Keywords
- B-CLL, vaccine, Lenalidomide, CTL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 May 2012 (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.
This is a research study to determine the safety and effectiveness of using special cells that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in combination with a drug called Lenalidomide.
To do this, the investigators will put a special gene into cancer cells that have been taken from the subject. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the subject's immune system kill cancer cells. Additionally, the investigators will stimulate the cancer cells with normal embryonic fibroblasts (cells that develop into normal connective tissues in the body) so that they will make another natural protein called CD40 ligand (CD40L). Some of these cells will then be put back into the subject's body with the goal that they will act like a vaccine and stimulate the immune system to attack the CLL cells.
The investigators have already conducted a study similar to this in other subjects with CLL. In those subjects the investigators saw some changes in the subject's immune system that might indicate that the modified cells were helping their immune system fight the cancer. However, in most of the subjects this change in the immune system went away after the injections were stopped. The investigators think that this may be due to a high level of cells called T regulatory cells. T regulatory cells are part of the immune system and prevent excessive reactions from other cells in the body. Studies have shown that reducing T regulatory cells allows the body to fight the cancer for a longer period of time.
Recent studies have shown that using Lenalidomide helps the body reduce T regulatory cells. Using Lenalidomide along with the injections (shots) might help the body fight the cancer for a longer period of time. Lenalidomide is also called Revlimid.
In this study the investigators want to see if they can make the change in the immune system last longer by giving Lenalidomide before and at the same time as the vaccine. The investigators hope that this might produce a better response directed at the CLL cells. Subjects will receive injections for about a year
Detailed description
Previously, some of the cancer cells were taken from the subject's body and separated in the laboratory and a specially produced human virus (adenovirus) that carries the IL-2 gene was put into the cells. Adenovirus is a common virus found in human respiratory systems. In its normal state, it can reproduce and cause a respiratory infection. Respiratory illnesses caused by adenovirus infections range from the common cold to pneumonia, croup and bronchitis. This adenovirus has been changed in the laboratory so that it is not likely to reproduce or cause an infection once it is in the body. The gene transfer method used in this study tries to add copies of the IL2 gene that increases the immune response against a tumor.
The rest of the cancer cells have been stimulated to express on their surface a substance called the human CD40L. These substances (IL-2 and CD40L), already naturally present in the body, are meant to help the immune system fight the cancer.
At the point that the doctor feels the subject should begin treatment on this protocol, the treatment will be as follows:
The subject will begin taking Allopurinol by mouth at 300 mg and will continue taking Allopurinol daily for 14 days. Allopurinol is also called Zyloprim and it will be taken to prevent tumor lysis syndrome. Tumor lysis syndrome can be a serious condition that occurs sometimes when cancer treatment is started. Tumor lysis syndrome can cause other medical problems.
Two days after Allopurinol was started, the subject will begin taking Lenalidomide. The Lenalidomide dose will be 5 mg taken by mouth daily. The subject should swallow the capsules whole with water at the same time each day and should not break, chew or open the capsules. Females of childbearing potential who are caring for the subject should not touch the lenalidomide capsules or bottles without gloves. If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up. If more than the prescribed dose is taken of lenalidomide and the subject feels poorly, s/he should seek emergency medical care and tell the study staff right away. The subject will get 1 cycle of drug per month. A max of a 28-day supply of the drug will be provided at one time. If the subject has bad side effects the doctor may tell him/her not to take the lenalidomide for a short time period or may be removed from the study. Otherwise, the subject will continue daily dosing with Lenalidomide for approximately 1 year, until four weeks after the final vaccine.
Four weeks after the subject starts the Lenalidomide s/he will start to receive his/her vaccines. The vaccine will be injected under the skin (also called subcutaneously). Normally the subject will have the shots as an outpatient (no overnight stay in the hospital will be required). S/he will receive the first five (5) shots at 2 week intervals. S/he will then receive eleven (11) shots at 4 weekly intervals. In total, the subject may receive up to sixteen (16) shots over a period of one year. As with the Lenalidomide if the subject has bad side effects s/he may not receive his/her vaccines for a short period of time or may be removed from the study. Otherwise, the subject will receive the vaccines on the schedule as specified earlier in this paragraph. These shots must be given at Houston Methodist Hospital.
Following these injections, the doctor will follow the subject for 1 year after the last shot to see how the subject is doing.
TESTS DURING AND AFTER EXPERIMENTAL TREATMENT:
A complete history and physical examination is necessary before the subject can be enrolled in the study. A physical examination will also be performed each time s/he receives a shot of the modified cells. The place on the subject's body where s/he had received the shots will be examined during the physical exam.
Research Blood Samples:
Blood will be taken from a tube placed into the vein (IV). We will take blood samples at the following time points: at study entry, week 0 when the subject starts Lenalidomide, weeks 2, 4, 6, 8, 10 and 16 and then every 4 weeks until week 60. The last blood sample will be at one year after the last shot. We will do this to make sure that the Lenalidomide is working correctly and to study how the modified cells are working in the body.
The amount of blood that will be obtained each time is approximately 2-3 tablespoonfuls, which is considered to be a safe amount. If the subject has a central line (an IV line that has been placed in a large blood vessel that is meant to be used for long periods of time), the blood will be taken from it, so that extra "sticks" should not be needed. Additional office visits may be necessary to obtain this blood. The maximum total amount of blood to be collected from the subject is 40-60 tablespoons.
Other tests: If the subject is a woman who can get pregnant, she will have pregnancy counseling and urine tests as long as she is taking lenalidomide.
In order to participate in this study, the subject must register into and follow the requirements of the Revlimid REMS® program of Celgene Corporation (the company that supplies Lenalidomide). This program provides education and counseling on the risks of fetal exposure, blood clots and reduced blood counts that can occur when taking Lenalidomide. The subject will be required to receive counseling every 28 days during treatment with lenalidomide, follow the pregnancy testing and birth control requirements of the program that are appropriate for him/her and take telephone surveys regarding your compliance with the program. Participating in the Revlimid REMS® program is a study requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-CLL vaccine | Experimental | Biological: B-CLL Vaccine, Drug: LenalidomidePatients will receive doses of vaccine at 2 week intervals for 5 doses and at 4 week intervals for doses 6-16. The injection will be performed subcutaneously in the deltoid region of the upper arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients with B-CLL (not in Richter's transformation) with measurable disease.
- Procurement consent signed and faxed to Research Coordinator
- HIV negative (can be pending at this time)
- Manipulated B-CLL cells available (at least 6 injections)
- Patients with B-CLL (not in Richter's transformation) with measurable disease
Key exclusion criteria (10 listed)
- Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole).
- Pregnant or lactating
- Suffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)
- Receiving immunosuppressive drugs.
- Received systemic steroids within 30 days of study enrollment
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 |
|---|---|---|
| B-CLL VaccinePatients will receive a fixed dose (2X10^7) of IL-2 secreting B-cells together with (2X10^7) of hCD40L expressing B-cells. Patients will receive doses of vaccine at 2 week intervals for 5 doses. Barring adverse events, an additional 11 doses of vaccine will be given, at 4 weekly intervals beginning on week 12 for a total period of one year or 16 vaccinations in total. | Biological | B-CLL vaccine |
| LenalidomideAlso: RevlimidSubjects will begin lenalidomide 5 mg orally daily on day zero and will continue daily dosing until week 60 (4 weeks after the final dose of vaccine). | Drug | B-CLL vaccine |
Primary outcome
Adverse Events after Lenalidomide with B-CLL cell vaccine
Time frame: week 60
To assess the safety of administration of lenalidomide combined with prolonged administration of CD40L expressing and IL-2 secreting B-CLL cells (B-CLL vaccine).
Changes in SP tumor cell population from pre-vaccine to four weeks post-vaccination
Time frame: week 4
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden and on the side population of tumor cells.
Changes in SP tumor cell population from pre-vaccine to eight weeks post vaccination
Time frame: week 8
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden and the side population of tumor cells.
Number of patients with a tumor response post vaccination
Time frame: 4 weeks
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden.
Number of patients with a tumor response post vaccination
Time frame: 8 weeks
To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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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.
Martha Mims, MD principal investigator
Baylor College of Medicine
Malcolm Brenner, MB, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing B-CLL Vaccine and Lenalidomide in people with B-cell Chronic Lymphocytic Leukemia, run by Baylor College of Medicine 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 24 inclusion and 10 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 8 Feb 2016. 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 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?
The study was stopped early. 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?
Adverse Events after Lenalidomide with B-CLL cell vaccine (time frame: week 60). The study lists 5 primary outcomes in all. 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 8 Feb 2016.