Malignant Neoplasms Stated as Primary Lymphoid HaematopoieticPhase 2NCT03207555
Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Ibrutinib in people with Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic and Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given. The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- What is being tested?
- Ibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2018to 2 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be age >/=18 years at the time of informed consent, understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations.
- No treatment indication according to IWCLL/NCI-WG (International Working Group in Chronic Lymphocytic Leukemia/National Cancer Institute-Working Group) 2008 criteria
- Estimated time to first treatment of 3 years or less according to MDACC nomogram
- ECOG performance status of 0-2
- Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. OR Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for >/=1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy)
- Adequate hepatic and renal function as indicated by all of the following: Total bilirubin </=1.5 x institutional Upper Limit of Normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease or of non-hepatic origin who will be allowed to participate, provided bilirubin is </=3 x institutional ULN; an ALT </=2.5 x ULN; and estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft- Gault equation.
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- PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).
- Free of prior malignancies for 3 years with exception of patients diagnosed with basal cell or non-metastatic squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast, who are eligible even if they are currently treated or were treated and/or diagnosed in the past 3 years prior to study enrolment
- Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria
Who cannot join
- Receipt of any prior therapy for CLL. Patients who have received "early intervention" with INVAC-1 vaccine against hTERT will be eligible provided all of the following exist: i) They had no response to the vaccine treatment (persistent CLL >1% in bone marrow). ii) ≥3 months have elapsed since the last dose of vaccine. iii) No residual toxicities attributable to the vaccine exist at the time of study enrollment. iv) The patient does not meet IWCLL criteria for requiring treatment.
- Richter Transformation
- Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Systemic anticoagulation with warfarin or other Vitamin K antagonists
- Active and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >/=20 mg
- Current and concurrent use of strong CYP3A4 inhibitors or inducers
Show all 20Show fewer
- Pregnant or breast-feeding females
- Uncontrolled and active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Any other severe concurrent disease, or history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that, in the investigator's opinion, may place the patient at undue risk to undergo therapy with ibrutinib
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
- History of ischemic stroke within 6 months prior to enrollment
- Evidence of bleeding diathesis or coagulopathy within 3 months (eg, von Willebrand's disease or hemophilia
- Any history of symptomatic intracranial hemorrhage
- Major surgical procedure with 4 weeks of first dose of study drug; open biopsy, or significant traumatic injury within 7 days prior to enrollment date; anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 3 days prior to enrollment date. Bone marrow aspiration and/or biopsy are allowed
- Serious, non-healing wound, ulcer, or bone fracture
- Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
- Active, uncontrolled infection
- Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded
- Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification (see Appendix L)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Ibrutinib Monotherapy in Early Stage Chronic Lymphocytic Leukemia (CLL) Without IWCLL/NCI-WG 2008 Treatment Indications But With High-Risk Features for Disease Progression
The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given.
The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms will be more effective than waiting until symptoms develop.
Read more
This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib to CLL and SLL patients before symptoms develop.
The study doctor can describe how the study drug is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take ibrutinib by mouth 1 time every day. Each dose should be taken with about 1 cup (8 ounces) of water.
If you miss a dose of ibrutinib, it can be taken as soon as possible on the same day. You should take your next dose as scheduled. If you forget to take a dose, do not take extra capsules on the next day to "make up" the missed dose.
You will be given standard drugs, such as allopurinol or valacyclovir, to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. If you have side effects, your dose of ibrutinib may be lowered or temporarily stopped until you recover from the side effects.
Length of Treatment:
You may take ibrutinib for up to 2 years (24 cycles). If at the end of 2 years you are benefitting from ibrutinib and the study doctor thinks it is in your best interest to continue taking it, other treatment options will be discussed with you to allow you to continue to take ibrutinib.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Study Visits:
Each cycle is 28 days.
On Day 28 of Cycles 1-3 and then every 3 cycles after that until Cycle 24 (Cycles 6, 9, 12, and so on):
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a physical exam.
- You will have an EKG.
On Day 28 of Cycles 1, 3, 6, 12, and 24, blood (about 3 tablespoons) will be drawn to test for genetic mutations related to the disease. At Months 3, 6, and 12, additional blood (about 8 teaspoons) will be drawn for immune system testing.
On Day 28 of Cycles 6, 12, 18 and 24, you will have CT, MRI or PET/CT scan to check the status of the disease. Depending on the results of the CT, MRI or PET/CT scans, you may not need to have these scans repeated. The doctor will discuss this with you.
On Day 28 of Cycles 6, 12 and 24, you will have a bone marrow biopsy to check the status of the disease.
If the doctor thinks it is needed or if the disease gets worse, some tests/procedures, such as physical exams and blood draws for routine tests, may be repeated more often.
Long-term follow-up:
Every 3 months, during a regularly scheduled clinic visit (if you are still receiving care at MD Anderson) or by phone (if you are receiving care outside of MD Anderson), you will be asked how you are doing, if you are still taking ibrutinib, and if you have any side effects. If called, this call should last about 5-10 minutes.
- Conditions
- Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- Being tested
- Ibrutinib
- Keywords
- Malignant neoplasms stated as primary lymphoid haematopoietic, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Leukemia, SLL, Ibrutinib, PCI-32765, Imbruvica
- 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.
IbrutinibDrug
Also called PCI-32765, Imbruvica
420 mg by mouth once daily.
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib | Experimental | Participants take Ibrutinib by mouth 1 time every day for up to 2 years (24 cycles). Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Complete Remission (CR) at 24 Months
Complete Remission (CR): Peripheral blood lymphocytes below 4 x 10^9/L (4000/ƒÝL), Absence of significant lymphadenopathy (lymph nodes >1.5 cm in diameter) by CT(or PET) examination of neck, thorax, abdomen and pelvis, No hepatomegaly or splenomegaly by physical examination (and CT/PET if assessment was abnormal before therapy or if physical exam is inconclusive), Absence of constitutional symptoms, Neutrophils more than 1.5 x 10^9/L (1500/ƒÝL) without need for exogenous growth factors, Platelets more than 100 x 10^9/L (100 000/ƒÝL) without need for exogenous growth factors, Hemoglobin more than 110 g/L (11.0 g/dL) without red blood cell transfusion or need for exogenous erythropoietin, Bone Marrow aspirate and biopsy, demonstrating at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent. If the bone marrow is hypocellular, a repeat determination should be made in 4 weeks or when peripheral blood counts have recovered.
Measured: Up to 24 months
Participants With Partial Remission (PR) at 24 Months
Partial Remission (PR) at least one of criteria 1-3, and one or more of the features listed in number 4. 1. A decrease lymphocytes by 50% or more from the value before therapy. 2. Reduction in lymphadenopathy, defined by the following: - A decrease in lymph node size by 50% or more either in the sum products of up to 6 lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy. - No increase in lymph node, and no new enlarged lymph node. In small lymph nodes (</=2 cm), an increase of less than 25% is not considered to be significant. 3. A reduction in enlargement of the spleen or liver by 50% or more. 4. The blood count should show one or more of the following results: - Neutrophils more than 1, without need for exogenous growth factors. - Platelet counts greater than 100 x10^9/L (100 000/ƒÝL) or 50% improvement over baseline without need for exogenous growth factors. - Hemoglobin greater than 11
Measured: Up to 24 months
Secondary outcomes (2)
Progression-Free Survival (PFS) at 24 Months
Time from date of treatment start until the date of progression or death from leukemia.
Measured: 24 months
Overall Response at 24 Months
Overall Response is participants who achieve Complete Remission (CR) or Partial Remission (PR) at 24 months of treatment.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start23 May 2018
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
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.
- Other trials for Malignant Neoplasms Stated as Primary Lymphoid HaematopoieticStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Responsible party
- Sponsor
- Investigators
- Jan Burger, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207555
- Sponsor's protocol ID
- 2017-0039
- Other IDs
- NCI-2018-01121
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2017
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibrutinib Monotherapy in Early Stage Chronic Lymphocytic Leukemia (CLL) Without IWCLL/NCI-WG 2008 Treatment Indications But With High-Risk Features for Disease Progression
- ClinicalTrials.gov ID
- NCT03207555
- Acronym / sponsor ID
- 2017-0039
- Conditions
- Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- Keywords
- Malignant neoplasms stated as primary lymphoid haematopoietic, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Leukemia, SLL, Ibrutinib, PCI-32765, Imbruvica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pharmacyclics LLC.
- Study start
- 23 May 2018 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 2 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard approach to managing chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) is to wait until you have symptoms before treatment is given.
The goal of this clinical research study is to learn if providing earlier treatment for CLL or SLL with ibrutinib in patients who do not have symptoms will be more effective than waiting until symptoms develop.
This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with CLL or SLL. It is considered investigational to give ibrutinib to CLL and SLL patients before symptoms develop.
The study doctor can describe how the study drug is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take ibrutinib by mouth 1 time every day. Each dose should be taken with about 1 cup (8 ounces) of water.
If you miss a dose of ibrutinib, it can be taken as soon as possible on the same day. You should take your next dose as scheduled. If you forget to take a dose, do not take extra capsules on the next day to "make up" the missed dose.
You will be given standard drugs, such as allopurinol or valacyclovir, to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. If you have side effects, your dose of ibrutinib may be lowered or temporarily stopped until you recover from the side effects.
Length of Treatment:
You may take ibrutinib for up to 2 years (24 cycles). If at the end of 2 years you are benefitting from ibrutinib and the study doctor thinks it is in your best interest to continue taking it, other treatment options will be discussed with you to allow you to continue to take ibrutinib.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Study Visits:
Each cycle is 28 days.
On Day 28 of Cycles 1-3 and then every 3 cycles after that until Cycle 24 (Cycles 6, 9, 12, and so on):
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a physical exam.
- You will have an EKG.
On Day 28 of Cycles 1, 3, 6, 12, and 24, blood (about 3 tablespoons) will be drawn to test for genetic mutations related to the disease. At Months 3, 6, and 12, additional blood (about 8 teaspoons) will be drawn for immune system testing.
On Day 28 of Cycles 6, 12, 18 and 24, you will have CT, MRI or PET/CT scan to check the status of the disease. Depending on the results of the CT, MRI or PET/CT scans, you may not need to have these scans repeated. The doctor will discuss this with you.
On Day 28 of Cycles 6, 12 and 24, you will have a bone marrow biopsy to check the status of the disease.
If the doctor thinks it is needed or if the disease gets worse, some tests/procedures, such as physical exams and blood draws for routine tests, may be repeated more often.
Long-term follow-up:
Every 3 months, during a regularly scheduled clinic visit (if you are still receiving care at MD Anderson) or by phone (if you are receiving care outside of MD Anderson), you will be asked how you are doing, if you are still taking ibrutinib, and if you have any side effects. If called, this call should last about 5-10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib | Experimental | Drug: IbrutinibParticipants take Ibrutinib by mouth 1 time every day for up to 2 years (24 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be age >/=18 years at the time of informed consent, understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations.
- No treatment indication according to IWCLL/NCI-WG (International Working Group in Chronic Lymphocytic Leukemia/National Cancer Institute-Working Group) 2008 criteria
- Estimated time to first treatment of 3 years or less according to MDACC nomogram
- ECOG performance status of 0-2
- Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. OR Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for >/=1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy)
Key exclusion criteria (20 listed)
- Receipt of any prior therapy for CLL. Patients who have received "early intervention" with INVAC-1 vaccine against hTERT will be eligible provided all of the following exist: i) They had no response to the vaccine treatment (persistent CLL >1% in bone marrow). ii) ≥3 months have elapsed since the last dose of vaccine. iii) No residual toxicities attributable to the vaccine exist at the time of study enrollment. iv) The patient does not meet IWCLL criteria for requiring treatment.
- Richter Transformation
- Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Systemic anticoagulation with warfarin or other Vitamin K antagonists
- Active and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >/=20 mg
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 |
|---|---|---|
| IbrutinibAlso: PCI-32765, Imbruvica420 mg by mouth once daily. | Drug | Ibrutinib |
Primary outcome
Participants With Complete Remission (CR) at 24 Months
Time frame: Up to 24 months
Complete Remission (CR): Peripheral blood lymphocytes below 4 x 10^9/L (4000/ƒÝL), Absence of significant lymphadenopathy (lymph nodes >1.5 cm in diameter) by CT(or PET) examination of neck, thorax, abdomen and pelvis, No hepatomegaly or splenomegaly by physical examination (and CT/PET if assessment was abnormal before therapy or if physical exam is inconclusive), Absence of constitutional symptoms, Neutrophils more than 1.5 x 10^9/L (1500/ƒÝL) without need for exogenous growth factors, Platelets more than 100 x 10^9/L (100 000/ƒÝL) without need for exogenous growth factors, Hemoglobin more than 110 g/L (11.0 g/dL) without red blood cell transfusion or need for exogenous erythropoietin, Bone Marrow aspirate and biopsy, demonstrating at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent. If the bone marrow is hypocellular, a repeat determination should be made in 4 weeks or when peripheral blood counts have recovered.
Participants With Partial Remission (PR) at 24 Months
Time frame: Up to 24 months
Partial Remission (PR) at least one of criteria 1-3, and one or more of the features listed in number 4. 1. A decrease lymphocytes by 50% or more from the value before therapy. 2. Reduction in lymphadenopathy, defined by the following: - A decrease in lymph node size by 50% or more either in the sum products of up to 6 lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy. - No increase in lymph node, and no new enlarged lymph node. In small lymph nodes (</=2 cm), an increase of less than 25% is not considered to be significant. 3. A reduction in enlargement of the spleen or liver by 50% or more. 4. The blood count should show one or more of the following results: - Neutrophils more than 1, without need for exogenous growth factors. - Platelet counts greater than 100 x10^9/L (100 000/ƒÝL) or 50% improvement over baseline without need for exogenous growth factors. - Hemoglobin greater than 11
2 secondary outcomes
Progression-Free Survival (PFS) at 24 Months
Time frame: 24 months
Overall Response at 24 Months
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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.
Jan Burger, MD 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 Ibrutinib in people with Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic and Chronic Lymphocytic Leukemia, 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 9 inclusion and 20 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 2 Sep 2025. 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 2025). 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?
Participants With Complete Remission (CR) at 24 Months (time frame: Up to 24 months). The study lists 2 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 2 Sep 2025.