Acute Myelogenous LeukemiaPhase 1TCP-ATRANCT02273102
Study of TCP-ATRA for Adult Patients With AML and MDS
A Phase 1 study testing Tranylcypromine and Tretinoin in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by University of Miami at 1 site in United States.
Trial summary
Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Leukemia
- What is being tested?
- Tranylcypromine and Tretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2015to 1 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of one of the following:
- Relapsed/refractory Acute Myelogenous Leukemia (AML) as defined by the World Health Organization (WHO) criteria [therapy-related AML and/or secondary AML from an antecedent hematologic disorder not excluded].
- Relapsed/refractory Myelodysplasic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria.
- Adult patients 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Adequate organ function as defined as:
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- Total bilirubin ≤ 1.5 x upper limited of normal (ULN)
- ALT and AST must be ≤ 3 × ULN
- Creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 50ml/min or
- PT and aPTT ≤ 1.5 × ULN
- Patients with total bilirubin, Alanine transaminase (ALT), Aspartate transaminase (AST), Creatinine, prothrombin time (PT), and activated partial thromboplastin time (aPTT) levels outside the permitted range are eligible if, in the judgment of the Principal Investigator, the levels are related to the patient's AML or MDS.
- Suitable venous access to allow for all study related blood sampling (safety and research).
- Estimated life expectancy, in the judgment of the Investigator, which will permit receipt of at least 6 weeks of treatment.
- Able to understand and willing to signed the written informed consent and HIPAA document/s.
Who cannot join
- Therapy with moderate or strong CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to Cycle1 Day1.
- Therapy with Monoamine Oxidase Inhibitors (MAOIs), dibenzazepine derivatives, sympathomimetics, or Selective Serotonin Reuptake Inhibitors (SSRIs) within 14 days prior to Cycle1 Day1. (Patients actively receiving a safe substitute in the judgment of the Principal Investigator are eligible and may continue to receive the safe substitute during protocol treatment)
- Therapy with any investigational products, antineoplastic therapy, or radiotherapy within 14 days prior to Cycle1 Day1. Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea during protocol treatment.
- Candidates for standard and/or potentially curative treatments. (Candidate defined as a patient that is both eligible and willing)
- Major surgery within 28 days prior to Cycle1 Day1.
- Grade 2 or higher diarrhea as defined by NCI CTCAE Version 4.03 despite optimal antidiarrheal supportive care within 7 days prior to Cycle1, Day1.
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- Myocardial infarction within 6 months (24 weeks) prior to Cycle1, Day1.
- Class III or IV heart failure as defined by the New York Heart Association (NYHA), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. (Any ECG abnormality at screening has to be documented by the investigator as not medically relevant and confirmed by the Principal Investigator)
- Active and uncontrolled infection.
- Known human immunodeficiency virus (HIV) positive.
- Known hepatitis B surface antigen-positive.
- Known or suspected active hepatitis C infections (Patients who are hepatitis C surface antigen-positive are eligible).
- Female patients who are pregnant women or breast feeding. Confirmation that the patient is not pregnant will require a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Females of child bearing potential who refused to either practice 2 effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 30 days after the last dose of study drug.
- Males of child bearing potential who refuse to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (includes males surgically sterilized - i.e. status post vasectomy).
- Serious medical or psychiatric illness/condition likely in the judgment of the Investigator to interfere with compliance to protocol treatment/research.
- Known history of allergic reaction to TCP or ATRA.
- Symptomatic central nervous system (CNS) involvement.
- A concurrent second active and non-stable malignancy (Patients with a concurrent second active but stable malignancy are eligible).
- Patients with proliferative AML will be excluded defined by a white blood cell count (WBC) > 5 x ULN UNLESS, the white count has been suppressed to < 5 x ULN with hydroxurea and has remained below this level for at least 2 weeks prior to enrollment on study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Dose Escalation Study of Tranylcypromine (TCP) in Combination With ATRA (Tretinoin) for Adult Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS)
Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes.
- Being tested
- Tranylcypromine, Tretinoin
- Keywords
- Acute Myelogenous Leukemia, AML, Myelodysplastic Syndromes, MDS, Tranylcypromine, TCP, ATRA, Tretinoin
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranylcypromineDrug
Also called TCP
Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each.
TretinoinDrug
Also called ATRA
45 mg/m2 of ATRA to be administered orally twice a day (12 hours apart), beginning on day 4 for up to 16 cycles of 21 days each.
| Study group | Role | What they receive |
|---|---|---|
| TCP Dose Level 1 | Experimental | 20mg of Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. 45 mg/m2 of Tretinoin (ATRA) to be administered orally twice a day (12 hours apart) beginning on day 4 of each 21 day cycle, for up to 16 cycles. Receives: Drug: Tranylcypromine; Drug: Tretinoin |
| TCP Dose Level 2 | Experimental | 40mg of Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. 45 mg/m2 of Tretinoin (ATRA) to be administered orally twice a day (12 hours apart) beginning on day 4 of each 21 day cycle, for up to 16 cycles. Receives: Drug: Tranylcypromine; Drug: Tretinoin |
| TCP Dose Level 3 | Experimental | 60mg of Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. 45 mg/m2 of Tretinoin (ATRA) to be administered orally twice a day (12 hours apart) beginning on day 4 of each 21 day cycle, for up to 16 cycles. Receives: Drug: Tranylcypromine; Drug: Tretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Toxicity in Study Participants Receiving TCP/ATRA Combination Therapy
The safety and tolerability of TCP/ATRA combination therapy in patients with Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS). This will be measured by the rate of adverse events, serious adverse events and other toxicities in study participants receiving protocol therapy.
Measured: 24 months
Secondary outcomes (3)
Rate of Preliminary Efficacy of TCP/ATRA Combination Therapy
Best response to TCP/ATRA combination therapy will be determined using serial blood and bone marrow sampling throughout the course of treatment. Responses will be documented according to revised/modified International Working Group (IWG) Response Criteria - Cheson et al. 2003 for AML and Cheson et al. 2006 for MDS. Morphologic complete remission (CR), cytogenetic CR, and molecular CR will be assessed by blood counts and simultaneous examination of the bone marrow fpr percentage of bone marrow blasts, as well as cytogenetics and molecular studies of bone marrow mononuclear cells
Measured: 24 months
Pharmacokinetics (PK) effects of TCP in plasma when combined with ATRA
Pharmacokinetics (PK) parameters will be determined using serial blood sampling at specified time points to determine PK effects of TCP in plasma when combined with ATRA. Non-compartmental methods of analysis will be used to determine TCP PK parameters following oral dosing of patients in Cycle 1. The following will be calculated: Observed maximum concentration (Cmax), the time at which Cmax occurred (Tmax), the area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC24hr), the terminal disposition phase half-life (t1/2).
Measured: Baseline, Cycle 1, Cycle 2, 30 Days (+/-10 days) Post-End of Treatment
Pharmacodynamic (PD) effects of TCP in peripheral blood and bone marrow when combined with ATRA.
Pharmacodynamics (PD) measurements will be obtained from serial blood and bone marrow sampling at specified time points to describe the PD effects of TCP when combined with ATRA. The following will be measured: Expression of CD11b by flow cytometry, gene expression analysis of leukemic blasts, measurement of Retinoic acid receptor alpha (RARα) and lysine (K)-specific demethylase 1A (LSD1) within leukemic blasts, leukemic engraftment of treated cells in immunodeficient mice.
Measured: Baseline, Cycle 1, Cycle 2, 30 Days (+/-10 days) Post-End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study start2 Mar 2015
- Primary completion8 Nov 2018
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Cancer Association, Gabrielle's Angel Foundation
- Responsible party
- Principal investigator, Justin Watts, MD, University of Miami
- Investigators
- Justin Watts, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273102
- Sponsor's protocol ID
- 20140328
- Acronym
- TCP-ATRA
- Status last verified
- Jul 2020
- First submitted
- 20 Oct 2014
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tayari MM, Santos HGD, Kwon D, Bradley TJ, Thomassen A, Chen C, Dinh Y, Perez A, Zelent A, Morey L, Cimmino L, Shiekhattar R, Swords RT, Watts JM. Clinical Responsiveness to All-trans Retinoic Acid Is Potentiated by LSD1 Inhibition and Associated with a Quiescent Transcriptome in Myeloid Malignancies. Clin Cancer Res. 2021 Apr 1;27(7):1893-1903. doi: 10.1158/1078-0432.CCR-20-4054. Epub 2021 Jan 25.
PubMed 33495312
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of Tranylcypromine (TCP) in Combination With ATRA (Tretinoin) for Adult Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS)
- ClinicalTrials.gov ID
- NCT02273102
- Acronym / sponsor ID
- TCP-ATRA / 20140328
- Keywords
- Acute Myelogenous Leukemia, AML, Myelodysplastic Syndromes, MDS, Tranylcypromine, TCP, ATRA, Tretinoin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Women's Cancer Association, Gabrielle's Angel Foundation
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 23 Oct 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.
Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TCP Dose Level 1 | Experimental | Drug: Tranylcypromine, Drug: Tretinoin20mg of Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. 45 mg/m2 of Tretinoin (ATRA) to be administered orally twice a day (12 hours apart) beginning on day 4 of each 21 day cycle, for up to 16 cycles. |
| TCP Dose Level 2 | Experimental | Drug: Tranylcypromine, Drug: Tretinoin40mg of Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. 45 mg/m2 of Tretinoin (ATRA) to be administered orally twice a day (12 hours apart) beginning on day 4 of each 21 day cycle, for up to 16 cycles. |
| TCP Dose Level 3 | Experimental | Drug: Tranylcypromine, Drug: Tretinoin60mg of Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. 45 mg/m2 of Tretinoin (ATRA) to be administered orally twice a day (12 hours apart) beginning on day 4 of each 21 day cycle, for up to 16 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Confirmed diagnosis of one of the following:
- Adult patients 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Adequate organ function as defined as:
- Suitable venous access to allow for all study related blood sampling (safety and research).
Key exclusion criteria (20 listed)
- Therapy with moderate or strong CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to Cycle1 Day1.
- Therapy with Monoamine Oxidase Inhibitors (MAOIs), dibenzazepine derivatives, sympathomimetics, or Selective Serotonin Reuptake Inhibitors (SSRIs) within 14 days prior to Cycle1 Day1. (Patients actively receiving a safe substitute in the judgment of the Principal Investigator are eligible and may continue to receive the safe substitute during protocol treatment)
- Therapy with any investigational products, antineoplastic therapy, or radiotherapy within 14 days prior to Cycle1 Day1. Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea during protocol treatment.
- Candidates for standard and/or potentially curative treatments. (Candidate defined as a patient that is both eligible and willing)
- Major surgery within 28 days prior to Cycle1 Day1.
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 |
|---|---|---|
| TranylcypromineAlso: TCPTranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each. | Drug | TCP Dose Level 1, TCP Dose Level 2, TCP Dose Level 3 |
| TretinoinAlso: ATRA45 mg/m2 of ATRA to be administered orally twice a day (12 hours apart), beginning on day 4 for up to 16 cycles of 21 days each. | Drug | TCP Dose Level 1, TCP Dose Level 2, TCP Dose Level 3 |
Primary outcome
Rate of Toxicity in Study Participants Receiving TCP/ATRA Combination Therapy
Time frame: 24 months
The safety and tolerability of TCP/ATRA combination therapy in patients with Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS). This will be measured by the rate of adverse events, serious adverse events and other toxicities in study participants receiving protocol therapy.
3 secondary outcomes
Rate of Preliminary Efficacy of TCP/ATRA Combination Therapy
Time frame: 24 months
Pharmacokinetics (PK) effects of TCP in plasma when combined with ATRA
Time frame: Baseline, Cycle 1, Cycle 2, 30 Days (+/-10 days) Post-End of Treatment
Pharmacodynamic (PD) effects of TCP in peripheral blood and bone marrow when combined with ATRA.
Time frame: Baseline, Cycle 1, Cycle 2, 30 Days (+/-10 days) Post-End of Treatment
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 21 Jul 2020.
- Derived from this study: PubMed 33495312Tayari MM, Santos HGD, Kwon D, Bradley TJ, Thomassen A, Chen C, Dinh Y, Perez A, Zelent A, Morey L, Cimmino L, Shiekhattar R, Swords RT, Watts JM. Clinical Responsiveness to All-trans Retinoic Acid Is Potentiated by LSD1 Inhibition and Associated with a Quiescent Transcriptome in Myeloid Malignancies. Clin Cancer Res. 2021 Apr 1;27(7):1893-1903. doi: 10.1158/1078-0432.CCR-20-4054. Epub 2021 Jan 25.
- Individual participant dataSharing planned: No
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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.
Justin Watts, MD principal investigator
University of Miami
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 Tranylcypromine and Tretinoin in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes, run by University of Miami 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 14 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 21 Jul 2020. 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?
Rate of Toxicity in Study Participants Receiving TCP/ATRA Combination Therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273102, which also lists 1 linked publication.
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 21 Jul 2020.