LeukemiaPhase 2NCT02028039
IPI-145 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
A Phase 2 study testing IPI-145 and Follow-up Visit/Call in people with Leukemia, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- IPI-145 and Follow-up Visit/Call
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previously treated ALL (including Burkitt's lymphoma, lymphoblastic lymphoma) in relapse or primary refractory. Patients with ALL or B or T cell origin may be treated. Patients in first relapse will be eligible regardless of the first remission duration. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely.
- Age 16 years or older. Pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
- Zubrod performance status 0-3.
- Adequate liver function (bilirubin </= 1.5 mg/dL and SGPT or SGOT </= 3 x upper limit of normal [ULN], unless considered due to tumor), and renal function (creatinine </= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dL and creatinine </= 3 mg/dL.
- Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as > 1 year postmenopausal or surgically sterilized).
Who cannot join
- Patient with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 45% are excluded.
- Patients who receive other chemotherapy. Patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the Principal Investigator.
- Prior allogeneic stem cell transplant in previous 3 months.
- Peripheral lymphoblasts > 50 x 109/L.
- Pregnant and breast-feeding patients are excluded.
- Patients with known hepatitis B or C are excluded.
About this study
Official title: Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With IPI-145
The goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied.
Read the detailed description
Study Drug Administration:
If patient is found to be eligible to take part in this study, they will receive IPI-145 by mouth twice a day for a month (30 days). Patient should swallow IPI-145 whole with a glass of water (about 8 ounces). If patient forgets to take a dose or if they vomit, they should not take another dose.
Each study cycle lasts 30 days.
Patient's dose of the study drug may change depending on any side effects they may have.
Study Visits:
Patient will have a physical exam within 1 week before Day 1 of each study cycle.
The first 2 cycles are called induction and all cycles after that are called consolidation cycles. Blood (about 1 tablespoon each time) will be drawn 1 to 3 times a week during induction (Cycles 1 and/or 2) and then at least 1 time a week during consolidation. How often blood will be drawn will be based on the study doctor's decision. These blood draws may be done at a clinic close to where patient lives if they choose.
Patient will have a bone marrow aspirate and/or biopsy between Days 14-21 (+/- 3 days) of Cycle 1 then every 1-2 cycles to check the status of the disease. Patient may have additional bone marrow aspirates and/or biopsies if their doctor thinks it is necessary.
Length of Study:
Patient may receive IPI-145 for up to 24 months if the doctor thinks it is in their best interest. Patient will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Patient's participation on the study will be over after the follow-up visit/call.
Follow-up Visit/Call:
Patient will have a follow-up visit 30 days after their last dose of the study drug. At this visit, patient will be asked about any side effects they may be having. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes.
This is an investigational study. IPI-145 is not FDA approved or commercially available. Its use in this study is investigational.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Leukemia
- Being tested
- IPI-145, Follow-up Visit/Call
- Keywords
- Leukemia, Refractory Acute Lymphoblastic Leukemia, ALL, Burkitt's lymphoma, Lymphoblastic lymphoma, IPI-145
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145Drug
75 mg orally twice daily for 4 weeks.
Follow-up Visit/CallBehavioural
Follow-up visit 30 days after last dose of study drug. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| IPI-145 | Experimental | IPI-145 given at dose of 75 mg orally twice daily for 4 weeks. Courses repeated about every 4 weeks (range 4-6 weeks). Receives: Drug: IPI-145; Behavioral: Follow-up Visit/Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Primary endpoint for efficacy is overall response rate (ORR) defined as complete remission (CR), complete remission without recovery of counts (CRi), or partial remission (PR). Overall response evaluated at the end of the first two cycles.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Infinity Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Susan O'Brien, MD, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028039
- Sponsor's protocol ID
- 2013-0204
- Status last verified
- Jan 2014
- First submitted
- 3 Jan 2014
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With IPI-145
- ClinicalTrials.gov ID
- NCT02028039
- Acronym / sponsor ID
- 2013-0204
- Conditions
- Leukemia
- Keywords
- Leukemia, Refractory Acute Lymphoblastic Leukemia, ALL, Burkitt's lymphoma, Lymphoblastic lymphoma, IPI-145
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Infinity Pharmaceuticals, Inc.
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 6 Jan 2014 (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 goal of this clinical research study is to learn if IPI-145 can help to control the disease in patients with ALL. The safety of the study drug will also be studied.
Detailed description
Study Drug Administration:
If patient is found to be eligible to take part in this study, they will receive IPI-145 by mouth twice a day for a month (30 days). Patient should swallow IPI-145 whole with a glass of water (about 8 ounces). If patient forgets to take a dose or if they vomit, they should not take another dose.
Each study cycle lasts 30 days.
Patient's dose of the study drug may change depending on any side effects they may have.
Study Visits:
Patient will have a physical exam within 1 week before Day 1 of each study cycle.
The first 2 cycles are called induction and all cycles after that are called consolidation cycles. Blood (about 1 tablespoon each time) will be drawn 1 to 3 times a week during induction (Cycles 1 and/or 2) and then at least 1 time a week during consolidation. How often blood will be drawn will be based on the study doctor's decision. These blood draws may be done at a clinic close to where patient lives if they choose.
Patient will have a bone marrow aspirate and/or biopsy between Days 14-21 (+/- 3 days) of Cycle 1 then every 1-2 cycles to check the status of the disease. Patient may have additional bone marrow aspirates and/or biopsies if their doctor thinks it is necessary.
Length of Study:
Patient may receive IPI-145 for up to 24 months if the doctor thinks it is in their best interest. Patient will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Patient's participation on the study will be over after the follow-up visit/call.
Follow-up Visit/Call:
Patient will have a follow-up visit 30 days after their last dose of the study drug. At this visit, patient will be asked about any side effects they may be having. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes.
This is an investigational study. IPI-145 is not FDA approved or commercially available. Its use in this study is investigational.
Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-145 | Experimental | Drug: IPI-145, Behavioral: Follow-up Visit/CallIPI-145 given at dose of 75 mg orally twice daily for 4 weeks. Courses repeated about every 4 weeks (range 4-6 weeks). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Previously treated ALL (including Burkitt's lymphoma, lymphoblastic lymphoma) in relapse or primary refractory. Patients with ALL or B or T cell origin may be treated. Patients in first relapse will be eligible regardless of the first remission duration. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely.
- Age 16 years or older. Pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
- Zubrod performance status 0-3.
- Adequate liver function (bilirubin </= 1.5 mg/dL and SGPT or SGOT </= 3 x upper limit of normal [ULN], unless considered due to tumor), and renal function (creatinine </= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dL and creatinine </= 3 mg/dL.
- Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as > 1 year postmenopausal or surgically sterilized).
Key exclusion criteria (7 listed)
- Patient with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).
- Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 45% are excluded.
- Patients who receive other chemotherapy. Patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the Principal Investigator.
- Prior allogeneic stem cell transplant in previous 3 months.
- Peripheral lymphoblasts > 50 x 109/L.
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 |
|---|---|---|
| IPI-14575 mg orally twice daily for 4 weeks. | Drug | IPI-145 |
| Follow-up Visit/CallFollow-up visit 30 days after last dose of study drug. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes. | Behavioural | IPI-145 |
Primary outcome
Overall Response Rate (ORR)
Time frame: 60 days
Primary endpoint for efficacy is overall response rate (ORR) defined as complete remission (CR), complete remission without recovery of counts (CRi), or partial remission (PR). Overall response evaluated at the end of the first two cycles.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- University of Texas MD Anderson Cancer Center 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.
Susan O'Brien, MD, BA principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPI-145 and Follow-up Visit/Call in people with Leukemia, run by M.D. Anderson Cancer Center.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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: 60 days). 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 6 Jan 2014.