Acute Myeloid LeukemiaPhase 1NCT02676323
Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 1 study testing Panobinostat, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by St. Jude Children's Research Hospital at 7 sites in United States.
Trial summary
Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs called "histone deacetylase (HDAC) inhibitors." HDAC inhibitors like panobinostat block enzymes known as histone deacetylases, which stops… Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Panobinostat, Fludarabine and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 May 2016to 9 Apr 2018
- 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 Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must have a diagnosis of AML or MDS and must have disease that has relapsed or is refractory to chemotherapy, or that has relapsed after hematopoietic stem cell transplantation (HSCT).
- Refractory disease is defined as persistent disease after at least two courses of induction chemotherapy.
- Patients with AML must have ≥ 5% leukemic blasts in the bone marrow or increasing levels of minimal residual disease (MRD) in the bone marrow as assessed by flow cytometry. If an adequate bone marrow sample cannot be obtained, patients may be enrolled if there is unequivocal evidence of leukemia in the peripheral blood.
- Adequate organ function defined as the following:
- Direct bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
- AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
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- Creatinine ≤ 1.5 x ULN for age
- Serum albumin > 3.0 g/dl
- Left ventricular ejection fraction ≥ 40% or shortening fraction ≥ 25%.
- Age ≤ 24 years
- Patients must be able to swallow capsules
- Performance status: Lansky ≥ 50 for patients who are ≤ 16 years old and Karnofsky ≥ 50% for patients who are > 16 years old.
- Patients must have fully recovered from the acute effects of all prior therapy and must meet the following criteria:
- At least 14 days must have elapsed since the completion of myelosuppressive therapy
- At least 24 hours must have elapsed since the completion of low-dose chemotherapy, such as hydroxyurea or low-dose cytarabine (up to 200 mg/m^2/day).
- For patients who have received prior HSCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HSCT. Patients cannot be receiving therapy, including steroids, for the treatment or prevention of GVHD. All such medications must be discontinued at least 24 hours prior to enrollment.
- Body Surface Area: Because the smallest capsule size available for the panobinostat is 10 mg, the minimum BSA allowed for enrollment at Dose Level 1 to 0.85 m^2. The minimum for Dose Level 2 is BSA=0.6 m^2 and the minimum for Dose Level 3 is BSA=0.42 m^2.
Who cannot join
- Must not be pregnant or breastfeeding. Female patients who are sexually active and of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients who are sexually active must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female patients who are sexually active, effective methods of contraception must be used throughout the study and for three months following the last dose. Abstinence is an acceptable form of contraception.
- Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible.
- Use of investigational agents within 30 days.
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study research.
- Uncontrolled infection within one week of the first dose. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.
- Known human immunodeficiency virus infection (pre-study testing not required).
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- Patient with diarrhea > CTCAE grade 2. (CTCAE version 4.0)
- Impaired cardiac function or clinically significant cardiac diseases, history of arrhythmia (including ventricular fibrillation or torsade de pointes), bradycardia <50 bpm, screening ECG with prolonged QTc (> 450 msec), uncontrolled hypertension or any history or presence of sustained ventricular tachyarrhythmia.
- Impairment of GI function or GI disease that may significantly alter the absorption of panobinostat.
- Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting treatment. Granisetron may be administered, but antiemetics associated with QT prolongation (e.g., ondansetron) are not allowed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Hospital of Michigan
Detroit, Michigan, 48201
Cook Children's Medical Center
Fort Worth, Texas, 76104
Children's Hospital Los Angeles
Los Angeles, California, 90027
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Rady Children's Hospital and Health Center
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination With Fludarabine and Cytarabine in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs called "histone deacetylase (HDAC) inhibitors." HDAC inhibitors like panobinostat block enzymes known as histone deacetylases, which stops cancer cells from dividing and causes them to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to treat pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
The purpose of this study is to test the safety of panobinostat and to find the highest dose of panobinostat that can be given safely when it is combined with fludarabine and cytarabine.
Read more
This pilot study will be done in two parts: The goal of Part 1 of the study is to find the highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when it is combined with fludarabine and cytarabine. Once that dose is determined, participants will be enrolled on Part 2: Dose Expansion, to look at the effect of the panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS.
PRIMARY OBJECTIVE:
- Determine a tolerable dose of panobinostat when given in combination with fludarabine and cytarabine in pediatric patients with relapsed or refractory AML or MDS.
SECONDARY OBJECTIVES:
- Characterize the pharmacokinetics of panobinostat after the first dose and at steady-state.
- Estimate the overall response rate to the combination of panobinostat, fludarabine, and cytarabine.
Read the detailed description
STUDY PART 1: Dose Escalation Cohort
During the dose escalation phase (Part 1), participants will receive one course of panobinostat plus fludarabine and cytarabine. The starting dose of panobinostat will be 10 mg/m^2/dose, with 2 additional dose levels of 15 and 20, depending on tolerability. Each course is 12 days
STUDY PART 2: Dose Expansion Cohort
The recommended phase 2 dose (RP2D) will be chosen based on the maximum tolerated dose (MTD) and the totality of data obtained from study Part 1. Additional patients will be enrolled, if needed, so that at least 6 patients are treated with the recommended RP2D to confirm the MTD of panobinostat to be given in study Part 2.
After final MTD determination, 12 additional participants will be treated at this dose level for further evaluation of tolerability and response, including more complete toxicity data and estimation of the response rate to the combination of panobinostat, fludarabine, and cytarabine.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- Panobinostat, Fludarabine, Cytarabine, Intrathecal Triples, Leucovorin
- Keywords
- Maximum tolerated dose, Childhood leukemia, Hematological malignancies
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanobinostatDrug
Also called LBH589
Panobinostat will be given orally (PO) on days 1, 3, 5, 8, 10, and 12.
FludarabineDrug
Also called Fludara®, Fludarabine phosphate, 2-fluoro-ara-AMP
Fludarabine will be given intravenously (IV), 30 mg/m^2/dose over 30 minutes, daily for 5 days (days 8-12).
CytarabineDrug
Also called Cytosine arabinoside, Ara-C, Cytosar®
Cytarabine will be given IV, 2 gram/m^2/dose over 4 hours, daily for 5 days (days 8-12).
Intrathecal TriplesDrug
Also called ITMHA, methotrexate/hydrocortisone/cytarabine
Given intrathecally (IT).
LeucovorinDrug
Also called Leucovorin calcium, Leucovorin rescue
Leucovorin (5 mg/m^2/dose, max 5 mg) may be given PO or IV at 24 and 30 hours after each ITMHA.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will be given panobinostat in combination with fludarabine and cytarabine. Treatment consists of one course of therapy given over 12 days. Participants will also receive intrathecal triples and leucovorin Receives: Drug: Panobinostat; Drug: Fludarabine; Drug: Cytarabine; Drug: Intrathecal Triples; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Any participant who experiences non-hematologic dose-limiting toxicity (DLT) during the first 28 days after taking the initial dose of panobinostat and before receiving non-protocol therapy is considered evaluable for toxicity. Non-hematologic DLT includes any Grade 5 event and any Grade 3 or 4 event that is at least possibly related to panobinostat, unless the event is clearly due to extraneous causes or disease progression. Hematologic DLT includes failure to recover counts by Day 56 in the absence of persistent leukemia.
Participants without DLTs who receive at least 5 of the 6 prescribed cycle I doses of panobinostat and can be followed for 28 days (56 days for evaluation of hematologic toxicity) after their initial dose of panobinostat are considered evaluable for toxicity. Participants who are not evaluable for toxicity will be replaced.
The MTD is defined as the highest dose level at which six participants have been treated with at most one participant experiencing a DLT.
Measured: Up to 56 days following first dose of panobinostat
Secondary outcomes (10)
Clearance (CL)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the clearance.
Measured: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Clearance (CL)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the clearance.
Measured: On day 8 from pre-dose through 48 hours after panobinostat administration
Drug Absorption (ka)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the drug absorption.
Measured: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Drug Absorption (ka)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the drug absorption.
Measured: On day 8 from pre-dose through 48 hours after panobinostat administration
Area under curve (AUC)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The AUC will be estimated based on the individual estimated PK.
Measured: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Area under curve (AUC)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The AUC will be estimated based on the individual estimated PK.
Measured: On day 8 from pre-dose through 24 hours after panobinostat administration
Maximum concentration (Cmax)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The Cmax will be estimated based on the individual estimated PK.
Measured: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Maximum concentration (Cmax)
Plasma samples will be analyzed via a validated method for plasma panobinostat concentration. Panobinostat concentration data will be analyzed in a non-linear mixed effects population pharmacokinetic (PK) model to determine the PK parameters. The Cmax will be estimated based on the individual estimated PK.
Measured: On day 8 from pre-dose through 24 hours after panobinostat administration
Complete response (CR) rate
Response will be based on blast percentage by flow cytometry. Blast percentages determined by morphology will be used in cases that are not evaluable by flow cytometry.
The efficacy of the combination of panobinostat and chemotherapy, as measured by the CR rate will be assessed for patients enrolled at the MTD. The rate of CR will be presented as a point estimate with a 95% exact binomial confidence interval.
Measured: Up to Day 42 after completion of therapy
Overall response (OR) rate
Response will be based on blast percentage by flow cytometry. Blast percentages determined by morphology will be used in cases that are not evaluable by flow cytometry.
The efficacy of the combination of panobinostat and chemotherapy, as measured by the OR (CR + incomplete blood count recovery + partial response + therapeutic success) will be assessed for the patients enrolled at the MTD. The rate of OR will be presented as a point estimate with a 95% confidence interval.
Measured: Up to Day 42 after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start3 May 2016
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey E. Rubnitz, MD,PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676323
- Sponsor's protocol ID
- PANAML
- Other IDs
- NCI-2016-00098
- Status last verified
- Nov 2018
- First submitted
- 3 Feb 2016
- Last updated
- 14 Nov 2018
- 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 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination With Fludarabine and Cytarabine in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02676323
- Acronym / sponsor ID
- PANAML
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Keywords
- Maximum tolerated dose, Childhood leukemia, Hematological malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 3 May 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 8 Feb 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.
Cancer is the uncontrolled growth of human cells. The growth of normal human cells is controlled by multiple mechanisms. Panobinostat belongs to a class of chemotherapy drugs called "histone deacetylase (HDAC) inhibitors." HDAC inhibitors like panobinostat block enzymes known as histone deacetylases, which stops cancer cells from dividing and causes them to die. Fludarabine and cytarabine are chemotherapy drugs that are commonly used to treat pediatric patients with refractory or relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
The purpose of this study is to test the safety of panobinostat and to find the highest dose of panobinostat that can be given safely when it is combined with fludarabine and cytarabine.
This pilot study will be done in two parts: The goal of Part 1 of the study is to find the highest tolerable dose of panobinostat that can be given to patients with AML or MDS, when it is combined with fludarabine and cytarabine. Once that dose is determined, participants will be enrolled on Part 2: Dose Expansion, to look at the effect of the panobinostat/fludarabine/cytarabine combination in patients with leukemia/MDS.
PRIMARY OBJECTIVE:
- Determine a tolerable dose of panobinostat when given in combination with fludarabine and cytarabine in pediatric patients with relapsed or refractory AML or MDS.
SECONDARY OBJECTIVES:
- Characterize the pharmacokinetics of panobinostat after the first dose and at steady-state.
- Estimate the overall response rate to the combination of panobinostat, fludarabine, and cytarabine.
Detailed description
STUDY PART 1: Dose Escalation Cohort
During the dose escalation phase (Part 1), participants will receive one course of panobinostat plus fludarabine and cytarabine. The starting dose of panobinostat will be 10 mg/m^2/dose, with 2 additional dose levels of 15 and 20, depending on tolerability. Each course is 12 days
STUDY PART 2: Dose Expansion Cohort
The recommended phase 2 dose (RP2D) will be chosen based on the maximum tolerated dose (MTD) and the totality of data obtained from study Part 1. Additional patients will be enrolled, if needed, so that at least 6 patients are treated with the recommended RP2D to confirm the MTD of panobinostat to be given in study Part 2.
After final MTD determination, 12 additional participants will be treated at this dose level for further evaluation of tolerability and response, including more complete toxicity data and estimation of the response rate to the combination of panobinostat, fludarabine, and cytarabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Panobinostat, Drug: Fludarabine, Drug: Cytarabine, Drug: Intrathecal Triples, Drug: LeucovorinParticipants will be given panobinostat in combination with fludarabine and cytarabine. Treatment consists of one course of therapy given over 12 days. Participants will also receive intrathecal triples and leucovorin |
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Participants must have a diagnosis of AML or MDS and must have disease that has relapsed or is refractory to chemotherapy, or that has relapsed after hematopoietic stem cell transplantation (HSCT).
- Adequate organ function defined as the following:
- Age ≤ 24 years
- Patients must be able to swallow capsules
- Performance status: Lansky ≥ 50 for patients who are ≤ 16 years old and Karnofsky ≥ 50% for patients who are > 16 years old.
Key exclusion criteria (10 listed)
- Must not be pregnant or breastfeeding. Female patients who are sexually active and of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients who are sexually active must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female patients who are sexually active, effective methods of contraception must be used throughout the study and for three months following the last dose. Abstinence is an acceptable form of contraception.
- Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible.
- Use of investigational agents within 30 days.
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, study participation, follow up, or interpretation of study research.
- Uncontrolled infection within one week of the first dose. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.
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 |
|---|---|---|
| PanobinostatAlso: LBH589Panobinostat will be given orally (PO) on days 1, 3, 5, 8, 10, and 12. | Drug | Treatment |
| FludarabineAlso: Fludara®, Fludarabine phosphate, 2-fluoro-ara-AMPFludarabine will be given intravenously (IV), 30 mg/m^2/dose over 30 minutes, daily for 5 days (days 8-12). | Drug | Treatment |
| CytarabineAlso: Cytosine arabinoside, Ara-C, Cytosar®Cytarabine will be given IV, 2 gram/m^2/dose over 4 hours, daily for 5 days (days 8-12). | Drug | Treatment |
| Intrathecal TriplesAlso: ITMHA, methotrexate/hydrocortisone/cytarabineGiven intrathecally (IT). | Drug | Treatment |
| LeucovorinAlso: Leucovorin calcium, Leucovorin rescueLeucovorin (5 mg/m^2/dose, max 5 mg) may be given PO or IV at 24 and 30 hours after each ITMHA. | Drug | Treatment |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Up to 56 days following first dose of panobinostat
Any participant who experiences non-hematologic dose-limiting toxicity (DLT) during the first 28 days after taking the initial dose of panobinostat and before receiving non-protocol therapy is considered evaluable for toxicity. Non-hematologic DLT includes any Grade 5 event and any Grade 3 or 4 event that is at least possibly related to panobinostat, unless the event is clearly due to extraneous causes or disease progression. Hematologic DLT includes failure to recover counts by Day 56 in the absence of persistent leukemia. Participants without DLTs who receive at least 5 of the 6 prescribed cycle I doses of panobinostat and can be followed for 28 days (56 days for evaluation of hematologic toxicity) after their initial dose of panobinostat are considered evaluable for toxicity. Participants who are not evaluable for toxicity will be replaced. The MTD is defined as the highest dose level at which six participants have been treated with at most one participant experiencing a DLT.
10 secondary outcomes
Clearance (CL)
Time frame: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Clearance (CL)
Time frame: On day 8 from pre-dose through 48 hours after panobinostat administration
Drug Absorption (ka)
Time frame: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Drug Absorption (ka)
Time frame: On day 8 from pre-dose through 48 hours after panobinostat administration
Area under curve (AUC)
Time frame: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Area under curve (AUC)
Time frame: On day 8 from pre-dose through 24 hours after panobinostat administration
Maximum concentration (Cmax)
Time frame: From baseline pre-dose day 1 through 48 hours after panobinostat administration
Maximum concentration (Cmax)
Time frame: On day 8 from pre-dose through 24 hours after panobinostat administration
Complete response (CR) rate
Time frame: Up to Day 42 after completion of therapy
Overall response (OR) rate
Time frame: Up to Day 42 after completion of therapy
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink 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.
Jeffrey E. Rubnitz, MD,PhD principal investigator
St. Jude Children's Research Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Panobinostat, Fludarabine and Cytarabine in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by St. Jude Children's Research Hospital at 7 sites 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 17 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 (reason given: Slow accrual). 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?
Maximum tolerated dose (MTD) (time frame: Up to 56 days following first dose of panobinostat). 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 14 Nov 2018.