LeukemiaPhase 1NCT02652871
LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing LY2510924, Idarubicin and Cytarabine in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn about the safety of LY2510924 in combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We will also study if LY2510924 in combination with cytarabine and idarubicin can help to control relapsed or refractory AML. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leukemia
- What is being tested?
- LY2510924, Idarubicin and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2016to 16 Jul 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with histologically or cytologically confirmed relapsed or refractory AML [except acute promyelocytic leukemia]; relapsed disease or refractory (refractory to a non-high-dose cytarabine-containing regimen only); receiving 1st, 2nd or 3rd salvage; any cytogenetic or molecular abnormality. Patients with secondary AML (after prior myelodysplasia or therapy for other cancers) will be included.
- Patients with prior autologous and allogeneic hematopoietic stem cell transplantation are eligible if patients are off immunosuppression for greater than 14 days and have no evidence of active graft versus host disease (GVHD) except grade 1 skin GVHD.
- Clinical laboratory values should be as follows: (a) White blood count < 30,000/µL; (b) Absolute Blasts in peripheral blood < 20,000 (treatment with Hydroxyurea is permitted up to 24 hrs prior to LY251092 administration to achieve blast counts < 20,000 prior to enrollment).
- Patients must be 18-70 years old.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL). If creatinine is > 1 mg/dL the creatinine clearance should be > 40 mL/min as calculated using the Cockcroft-Gault formula.
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- Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 X the upper limit of normal [ULN] for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin excretion disorder). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the Principal Investigator and appropriate dose adjustments will be considered.
- Patients must have normal cardiac ejection fraction (left ventricular ejection fraction [LVEF] greater than or equal to 50%).
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
- Negative urine or blood pregnancy test for women of childbearing potential.
- Female patients must not be pregnant or lactating. Female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
Who cannot join
- Patients with untreated or uncontrolled life-threatening infection.
- Patients who have received chemotherapy and/or radiation therapy within 2 weeks unless there is evidence of rapidly progressive disease. In the event that subjects have received chemotherapy < 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to less than or equal to grade 1. Hydroxyurea is allowed up to 24 hours prior to starting therapy in the setting of rapidly proliferating disease.
- Patients who have received an investigational anti-cancer drug within two weeks (or five half-lives, whichever is shorter) of LY251092 administration.
- History of myocardial infarction or cerebrovascular accident within 6 months of enrollment date.
- History of another malignancy. Exception: Patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible.
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression (patients with controlled central nervous system (CNS) disease, i.e. asymptomatic and currently receiving concurrent intrathecal chemotherapy, are eligible upon discussion with the Principal InvestigatorI).
- Known active Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection (patients with chronic or cleared HBV and HCV infection, are eligible).
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: A Phase 1b, Open-label Study of LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The goal of this clinical research study is to learn about the safety of LY2510924 in combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We will also study if LY2510924 in combination with cytarabine and idarubicin can help to control relapsed or refractory AML.
LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream, where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).
Read more
This is an investigational study. LY2510924 is not FDA approved or commercially available. Its use in this study is investigational. Cytarabine and idarubicin are approved to treat certain types of leukemia. Their use in this study in combination with LY2510924 is investigational.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of up to 6 participants each will be enrolled in the Dose Escalation part of the study, and up to 18 participants will be enrolled in Dose Expansion part of the study.
If you are enrolled in the Dose Escalation part of the study, the dose of LY2510924 you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of LY2510924. Each new group will receive a higher dose of LY2510924 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of LY2510924 is found.
If you are enrolled in the Dose Expansion part of the study, you will receive LY2510924 at the highest dose that was tolerated in the Dose Expansion part of the study.
All participants will also receive idarubicin and cytarabine. Your dose level will be assigned based on your age.
Study Drug Administration:
Treatment on this study is given in 2 phases: Induction and Consolidation. Each phase is made up of 28-day study cycles.
Induction Phase:
You will receive 1-2 cycles during the Induction phase. During Cycle 1, you will be admitted to the inpatient Leukemia service when you receive the study drugs.
You will receive LY2510924 alone each day for 7 days and then together with chemotherapy on Days 8, 9 and 10 and also on Day 11 if you are under the age of 60, of every 28-day cycle.
- On days that you do not receive idarubicin/cytarabine, LY2510924 will be given as an injection under the skin at about 8:00 am (+/- 1½ hours).
- On days when you do receive idarubicin/cytarabine, it will be given about 4 hours (+/- ½ hour) before you receive idarubicin.
On Days 8 and 9, in addition to LY2510924:
- You will receive idarubicin by vein over about 1 hour.
- You will receive cytarabine by vein over about 24 hours.
On Day 10, in addition to LY2510924:
- You will receive cytarabine by vein over about 24 hours.
- If you are under age 60, you will receive idarubicin by vein over about 1 hour.
If you are under age 60, on Day 11, in addition to LY2510924, you will receive cytarabine by vein over about 24 hours.
On days that you are receiving the cytarabine infusions, you will receive drugs to help reduce the risk of side effects. You will receive dexamethasone before the cytarabine infusion by vein over about 30 minutes. You will also receive corticosteroid-containing eye drops during this time and for 2 days following the last dose of cytarabine.
If the disease does not respond during Cycle 1, you may be allowed to receive an additional Induction cycle, which will also be called Cycle 1.If you do respond to Induction, you can move to the Consolidation phase.
Consolidation Phase:
If you are benefitting from the treatment, you may continue with Consolidation therapy for an additional 4-6 cycles.
During these cycles, you will receive LY2510924 in the same way as during earlier cycles, for 3 days with chemotherapy. During Consolidation, all participants will receive idarubicin by vein over 1 hour on Days 1 and 2, and cytarabine by vein over 24 hours on Days 1-3.
Study Visits:
During Days 1-12 of Cycle 1 (if over the age of 60, Days 1-10), blood (about 4 teaspoons) will be drawn for routine tests. During Days 1-7, blood (about 2 teaspoons) will be drawn 4 hours after your injection with LY2510924 for routine tests.
On Days 8 and 28 of Cycle 1, you will have a bone marrow biopsy/aspirate to check the status of the disease.
After Day 11 of Cycle 1, blood (about 4 teaspoons) will be drawn every 2-4 days for routine tests.
Every 1-2 weeks during Cycles 2-6, blood (about 4 teaspoons) will be drawn for routine tests.
Every 2-4 weeks during Cycles 2-6, you will have a physical exam.
After Cycles 4 and 6, you will have a bone marrow biopsy and aspiration to check the status of the disease. You will also have an EKG and either an ECHO or MUGA scan.
Any time the doctor thinks it is needed, you will have additional blood tests.
Length of Study:
You may receive up to 8 cycles of the study drugs. You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest.
Your participation on this study will be over after you complete the End-of-Treatment Visit.
End-of-Treatment Visit:
About 30 days (+/- 5 days) after your last dose of the study drugs, blood (about 2 teaspoons) will be drawn for routine tests.
Long Term Follow-up:
Every 2-3 months for up to 2 years after you stop receiving the study drugs, blood (about 4 teaspoons) will be drawn for routine tests. This can be performed at your local doctor's office. You should also have a bone marrow aspiration/biopsy every 3 months for the first year, and then more after that if the doctor thinks it is in your best interest. If any of these tests show abnormal results, you will return to the study clinic for follow-up testing.
- Conditions
- Leukemia
- Being tested
- LY2510924, Idarubicin, Cytarabine
- Keywords
- Leukemia, Acute Myeloid Leukemia, AML, Relapsed or Refractory, Acute myelogenous leukemia, LY2510924, Idarubicin, Idamycin, Cytarabine, Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2510924Drug
Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients.
Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase.
IdarubicinDrug
Also called Idamycin
Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients > 60 years of age Idarubicin given for 2 days.
Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days.
CytarabineDrug
Also called Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age < 60 years). In patients > 60 years of age Cytarabine given for 3 days only.
Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| LY2510924 + Idarubicin + Cytarabine | Experimental | Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients. On Day 8, LY2510924 administered after bone marrow aspiration and/or biopsy is performed.
Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase.
Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients > 60 years of age Idarubicin given for 2 days.
Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days.
Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age < 60 years). In patients > 60 years of age Cytarabine given for 3 days only.
Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days. Receives: Drug: LY2510924; Drug: Idarubicin; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity of LY2510924, Idarubicin and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Dose-limiting toxicity (DLT) defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness or concomitant medications. To be considered a DLT such toxicity must be possibly, probably or definitely related to LY2510924. Toxicity evaluated using the National Cancer Institute (NCI) Version 4.0 criteria.
Measured: 30 days post transplant
Secondary outcomes (1)
Response of LY2510924, Idarubicin and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia
International Working Group Criteria used to define response.
Complete remission (CR): Participant must be free of all symptoms related to leukemia and have an absolute neutrophil count (ANC), 1.0 x 109/L, platelet count, 100 x 109/L, and normal bone marrow differential (5% blasts).
Complete remission without platelet recovery (CRp): As per CR but platelet count 100 x 109/L.
Complete Remission with Incomplete Blood Count Recovery (CRi): Peripheral blood and bone marrow results as for CR except for ANC < 1.0 x 109/L with or without platelet count < 100 x 109/L.
Partial remission (PR): CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts.
Morphologic leukemia-free state: Normal marrow differential (5% blasts); neutrophil and platelet counts are not considered.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start9 May 2016
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, High Impact Clinical Research Support Program
- Responsible party
- Sponsor
- Investigators
- Marina Konopleva, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652871
- Sponsor's protocol ID
- 2015-0436
- Other IDs
- NCI-2016-00259
- Status last verified
- Nov 2019
- First submitted
- 8 Jan 2016
- Last updated
- 15 Nov 2019
- Results posted
- No
- 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 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label Study of LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02652871
- Acronym / sponsor ID
- 2015-0436
- Conditions
- Leukemia
- Keywords
- Leukemia, Acute Myeloid Leukemia, AML, Relapsed or Refractory, Acute myelogenous leukemia, LY2510924, Idarubicin, Idamycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, High Impact Clinical Research Support Program
- Study start
- 9 May 2016 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 12 Jan 2016 (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 about the safety of LY2510924 in combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We will also study if LY2510924 in combination with cytarabine and idarubicin can help to control relapsed or refractory AML.
LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream, where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).
This is an investigational study. LY2510924 is not FDA approved or commercially available. Its use in this study is investigational. Cytarabine and idarubicin are approved to treat certain types of leukemia. Their use in this study in combination with LY2510924 is investigational.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 3 groups of up to 6 participants each will be enrolled in the Dose Escalation part of the study, and up to 18 participants will be enrolled in Dose Expansion part of the study.
If you are enrolled in the Dose Escalation part of the study, the dose of LY2510924 you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of LY2510924. Each new group will receive a higher dose of LY2510924 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of LY2510924 is found.
If you are enrolled in the Dose Expansion part of the study, you will receive LY2510924 at the highest dose that was tolerated in the Dose Expansion part of the study.
All participants will also receive idarubicin and cytarabine. Your dose level will be assigned based on your age.
Study Drug Administration:
Treatment on this study is given in 2 phases: Induction and Consolidation. Each phase is made up of 28-day study cycles.
Induction Phase:
You will receive 1-2 cycles during the Induction phase. During Cycle 1, you will be admitted to the inpatient Leukemia service when you receive the study drugs.
You will receive LY2510924 alone each day for 7 days and then together with chemotherapy on Days 8, 9 and 10 and also on Day 11 if you are under the age of 60, of every 28-day cycle.
- On days that you do not receive idarubicin/cytarabine, LY2510924 will be given as an injection under the skin at about 8:00 am (+/- 1½ hours).
- On days when you do receive idarubicin/cytarabine, it will be given about 4 hours (+/- ½ hour) before you receive idarubicin.
On Days 8 and 9, in addition to LY2510924:
- You will receive idarubicin by vein over about 1 hour.
- You will receive cytarabine by vein over about 24 hours.
On Day 10, in addition to LY2510924:
- You will receive cytarabine by vein over about 24 hours.
- If you are under age 60, you will receive idarubicin by vein over about 1 hour.
If you are under age 60, on Day 11, in addition to LY2510924, you will receive cytarabine by vein over about 24 hours.
On days that you are receiving the cytarabine infusions, you will receive drugs to help reduce the risk of side effects. You will receive dexamethasone before the cytarabine infusion by vein over about 30 minutes. You will also receive corticosteroid-containing eye drops during this time and for 2 days following the last dose of cytarabine.
If the disease does not respond during Cycle 1, you may be allowed to receive an additional Induction cycle, which will also be called Cycle 1.If you do respond to Induction, you can move to the Consolidation phase.
Consolidation Phase:
If you are benefitting from the treatment, you may continue with Consolidation therapy for an additional 4-6 cycles.
During these cycles, you will receive LY2510924 in the same way as during earlier cycles, for 3 days with chemotherapy. During Consolidation, all participants will receive idarubicin by vein over 1 hour on Days 1 and 2, and cytarabine by vein over 24 hours on Days 1-3.
Study Visits:
During Days 1-12 of Cycle 1 (if over the age of 60, Days 1-10), blood (about 4 teaspoons) will be drawn for routine tests. During Days 1-7, blood (about 2 teaspoons) will be drawn 4 hours after your injection with LY2510924 for routine tests.
On Days 8 and 28 of Cycle 1, you will have a bone marrow biopsy/aspirate to check the status of the disease.
After Day 11 of Cycle 1, blood (about 4 teaspoons) will be drawn every 2-4 days for routine tests.
Every 1-2 weeks during Cycles 2-6, blood (about 4 teaspoons) will be drawn for routine tests.
Every 2-4 weeks during Cycles 2-6, you will have a physical exam.
After Cycles 4 and 6, you will have a bone marrow biopsy and aspiration to check the status of the disease. You will also have an EKG and either an ECHO or MUGA scan.
Any time the doctor thinks it is needed, you will have additional blood tests.
Length of Study:
You may receive up to 8 cycles of the study drugs. You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest.
Your participation on this study will be over after you complete the End-of-Treatment Visit.
End-of-Treatment Visit:
About 30 days (+/- 5 days) after your last dose of the study drugs, blood (about 2 teaspoons) will be drawn for routine tests.
Long Term Follow-up:
Every 2-3 months for up to 2 years after you stop receiving the study drugs, blood (about 4 teaspoons) will be drawn for routine tests. This can be performed at your local doctor's office. You should also have a bone marrow aspiration/biopsy every 3 months for the first year, and then more after that if the doctor thinks it is in your best interest. If any of these tests show abnormal results, you will return to the study clinic for follow-up testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2510924 + Idarubicin + Cytarabine | Experimental | Drug: LY2510924, Drug: Idarubicin, Drug: CytarabineDose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients. On Day 8, LY2510924 administered after bone marrow aspiration and/or biopsy is performed. Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase. Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients > 60 years of age Idarubicin given for 2 days. Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days. Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age < 60 years). In patients > 60 years of age Cytarabine given for 3 days only. Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All patients with histologically or cytologically confirmed relapsed or refractory AML [except acute promyelocytic leukemia]; relapsed disease or refractory (refractory to a non-high-dose cytarabine-containing regimen only); receiving 1st, 2nd or 3rd salvage; any cytogenetic or molecular abnormality. Patients with secondary AML (after prior myelodysplasia or therapy for other cancers) will be included.
- Patients with prior autologous and allogeneic hematopoietic stem cell transplantation are eligible if patients are off immunosuppression for greater than 14 days and have no evidence of active graft versus host disease (GVHD) except grade 1 skin GVHD.
- Clinical laboratory values should be as follows: (a) White blood count < 30,000/µL; (b) Absolute Blasts in peripheral blood < 20,000 (treatment with Hydroxyurea is permitted up to 24 hrs prior to LY251092 administration to achieve blast counts < 20,000 prior to enrollment).
- Patients must be 18-70 years old.
- Patients must have a performance status of 0-2 (Zubrod scale).
Key exclusion criteria (8 listed)
- Patients with untreated or uncontrolled life-threatening infection.
- Patients who have received chemotherapy and/or radiation therapy within 2 weeks unless there is evidence of rapidly progressive disease. In the event that subjects have received chemotherapy < 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to less than or equal to grade 1. Hydroxyurea is allowed up to 24 hours prior to starting therapy in the setting of rapidly proliferating disease.
- Patients who have received an investigational anti-cancer drug within two weeks (or five half-lives, whichever is shorter) of LY251092 administration.
- History of myocardial infarction or cerebrovascular accident within 6 months of enrollment date.
- History of another malignancy. Exception: Patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible.
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 |
|---|---|---|
| LY2510924Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients. Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase. | Drug | LY2510924 + Idarubicin + Cytarabine |
| IdarubicinAlso: IdamycinDose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients > 60 years of age Idarubicin given for 2 days. Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days. | Drug | LY2510924 + Idarubicin + Cytarabine |
| CytarabineAlso: Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine HydrochlorideDose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age < 60 years). In patients > 60 years of age Cytarabine given for 3 days only. Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days. | Drug | LY2510924 + Idarubicin + Cytarabine |
Primary outcome
Dose Limiting Toxicity of LY2510924, Idarubicin and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Time frame: 30 days post transplant
Dose-limiting toxicity (DLT) defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness or concomitant medications. To be considered a DLT such toxicity must be possibly, probably or definitely related to LY2510924. Toxicity evaluated using the National Cancer Institute (NCI) Version 4.0 criteria.
1 secondary outcome
Response of LY2510924, Idarubicin and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- 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.
Marina Konopleva, MD, PHD 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 1 study testing LY2510924, Idarubicin and Cytarabine in people with 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 11 inclusion and 8 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 15 Nov 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose Limiting Toxicity of LY2510924, Idarubicin and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia (time frame: 30 days post transplant). 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 15 Nov 2019.