NCT02339740 · CITED IN SOURCE DOCUMENTS

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-02-18

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients

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outcome · POSTED

EFS in High Risk APL Patients

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outcome · NOT POSTED

Induction Death Rate for Patients With FLT3 Mutations and Wild Type FLT3

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outcome · NOT POSTED

Disease Free Survival (DFS)

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outcome · NOT POSTED

Incidence of Serious Early Coagulopathy Events, Defined as Grade 3 or Higher Hemorrhage or Thrombosis

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outcome · NOT POSTED

Change in CogState Scores, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy

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outcome · NOT POSTED

Change in Parent-reported Executive Functioning Over Time, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy

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outcome · NOT POSTED

Change in Intellectual Functioning, Defined by Declines on the Wechsler-derived Estimated Intelligence Quotient and Processing Speed Scores

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outcome · NOT POSTED

Change in Memory Functioning, Defined by Declines on the Children's Memory Scale Faces and Stories Memory Scores

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outcome · NOT POSTED

Change in Verbal Learning Functioning, Defined by Declines on the California Verbal Learning Test Total Score

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outcome · NOT POSTED

Change in Adaptive Functioning, Defined by Declines on the Adaptive Behavior Assessment System-II General Adaptive Behavior Composite Score

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outcome · NOT POSTED

Change in Parent-reported Psychosocial Functioning Over Time

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outcome · NOT POSTED

Change in Parent-reported Quality of Life (QOL) Over Time

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Patients must be newly diagnosed with a clinical diagnosis of APL (initially by morphology of bone marrow or peripheral blood) * Bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted * If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible * NOTE: A lumbar puncture is not required in order to be enrolled on study nor are lumbar punctures recommended at the time of diagnosis; if the diagnosis of APL is known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms should be deferred until any coagulopathy is corrected; if central nervous system (CNS) disease is suspected or proven, a computed tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out the possibility of an associated chloroma; if CNS disease is documented, patients are still eligible and will receive protocol directed intrathecal treatments * Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy * Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of APL is not recommended * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Patients with secondary APL are excluded; this includes all patients with APL that may have resulted from prior treatment (chemotherapy or radiation) * Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded * Patients with a pre-existing diagnosis of a prolonged QT syndrome (even if corrected QT interval \[QTc\] is normal at the time of APL diagnosis) are excluded * Patients with a baseline QTc of \> 450 msec are excluded; Bazett's formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec) * Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded * Patients with right bundle branch block plus left anterior hemiblock, bifascicular block are excluded * Patients with serum creatinine \> 3.0 mg/dL and patients on active dialysis for renal dysfunction are excluded * Patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded * Female patients who are pregnant are excluded; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants are excluded * Sexually active patients of reproductive potential who have not agreed to be abstinent or use 2 forms of effective contraception during treatment through 1 month off therapy are excluded
healthy Volunteers: false
maximum Age: 21 Years
minimum Age: 12 Months
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
See Detailed Description
intervention Names
Drug: Arsenic Trioxide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Idarubicin
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Tretinoin
label
Treatment (tretinoin, arsenic trioxide, chemotherapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Given IV
name
Arsenic Trioxide
other Names
Arsenic (III) Oxide
Arsenic Sesquioxide
Arsenous Acid
Arsenous Acid Anhydride
Arsenous Oxide
ATO
Trisenox
White Arsenic
type
DRUG
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Given IV
name
Cytarabine
other Names
.beta.-Cytosine arabinoside
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-.beta.-D-Arabinofuranosylcytosine
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-Beta-D-arabinofuranosylcytosine
1.beta.-D-Arabinofuranosylcytosine
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Alexan
Ara-C
ARA-cell
Arabine
type
DRUG
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Given PO or IV
name
Dexamethasone
other Names
Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
type
DRUG
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Given IV
name
Idarubicin
other Names
4-Demethoxydaunomycin
4-Demethoxydaunorubicin
4-DMDR
type
DRUG
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Given IV
name
Mitoxantrone Hydrochloride
other Names
CL 232315
DHAD
DHAQ
Dihydroxyanthracenedione Dihydrochloride
Mitoxantrone Dihydrochloride
Mitoxantroni Hydrochloridum
Mitozantrone Hydrochloride
Mitroxone
Neotalem
Novantrone
Onkotrone
Pralifan
type
DRUG
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Ancillary studies
name
Questionnaire Administration
type
OTHER
arm Group Labels
Treatment (tretinoin, arsenic trioxide, chemotherapy)
description
Given PO
name
Tretinoin
other Names
2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-
Aberel
Airol
Aknoten
all trans-Retinoic acid
All-trans Retinoic Acid
All-trans Vitamin A Acid
all-trans-Retinoic acid
all-trans-Vitamin A acid
ATRA
Avita
beta-Retinoic Acid
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 158
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
A Fisher's exact test will be used to compare the induction death rate for patients with FLT3 mutations to patients with wild type FLT3.
measure
Induction Death Rate for Patients With FLT3 Mutations and Wild Type FLT3
time Frame
Up to 70 days
description
For patients in remission at the end of induction, the log-rank test will be used to test for differences in DFS for those with end of induction real-time quantitative polymerase chain reaction (RQ-PCR) of \< 1 normalized copy number (NCN) compared with those with end of Induction RQ-PCR \>= 1 NCN.
measure
Disease Free Survival (DFS)
time Frame
Up to 70 days
description
Will calculate the International Society of Thrombosis and Haemostasis (ISTH) disseminated intravascular coagulation (DIC) score and compare the sensitivity and specificity of ISTH with that of thrombomodulin using McNemar's test for paired data. To improve the predictive ability of the ISTH DIC score, will use a stepwise combination of biomarkers. Receiver operating characteristic (ROC) curve will be used to assess the accuracy in prediction of bleeding events during induction and the areas under the ROC curve will be compared.
measure
Incidence of Serious Early Coagulopathy Events, Defined as Grade 3 or Higher Hemorrhage or Thrombosis
time Frame
Up to 29 days of induction therapy
description
Actual CogState scores for each domain at each time point will be summarized and examined by descriptive statistics and scatter plots. Change in score for a domain from end of induction will be calculated and summarized by descriptive statistics. The mean change of score from end of induction to a later time-point will be estimated with its 95% confidence interval. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
measure
Change in CogState Scores, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy
time Frame
End of induction up to 2 years post-treatment
description
Measured by the Behavioral Regulation, Working Memory and Metacognition Indices of the Behavior Rating Inventory of Executive Function. Change in score for a domain from end of induction will be calculated and summarized by descriptive statistics. The mean change of score from end of induction to a later time-point will be estimated with its 95% confidence interval. Linear mixed models using scores from all time-points as outcome will be used to estimate change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
measure
Change in Parent-reported Executive Functioning Over Time, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy
time Frame
End of induction up to 2 years post-treatment
description
One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
measure
Change in Intellectual Functioning, Defined by Declines on the Wechsler-derived Estimated Intelligence Quotient and Processing Speed Scores
time Frame
End of treatment to 4 years post-treatment
description
One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
measure
Change in Memory Functioning, Defined by Declines on the Children's Memory Scale Faces and Stories Memory Scores
time Frame
End of treatment to 4 years post-treatment
description
One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
measure
Change in Verbal Learning Functioning, Defined by Declines on the California Verbal Learning Test Total Score
time Frame
End of treatment to 4 years post-treatment
description
One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
measure
Change in Adaptive Functioning, Defined by Declines on the Adaptive Behavior Assessment System-II General Adaptive Behavior Composite Score
time Frame
End of treatment to 4 years post-treatment
description
Psychosocial functioning over time as defined by declines on the Behavior Assessment System for Children-Second Edition (BASC-2) Anxiety, Depression, and Social Skills scores, and the Pediatric Quality of Life Inventory (PedsQL) Total and Physical Health scores.
measure
Change in Parent-reported Psychosocial Functioning Over Time
time Frame
End of treatment to 4 years off-therapy
description
QOL over time as defined as declines on the BASC-2 Anxiety, Depression, and Social Skills scores, and the PedsQL Total and Physical Health scores.
measure
Change in Parent-reported Quality of Life (QOL) Over Time
time Frame
End of treatment to 4 years

primary Outcomes

description
EFS is defined as the time from on study to failure to achieve hematological complete response (CR) prior to start of consolidation, persistence of molecular positive disease after minimal residual disease (MRD) positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits.
measure
Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients
time Frame
Up to 24 months
description
EFS is defined as the time from on study to failure to achieve hematological CR prior to start of consolidation, persistence of molecular positive disease after MRD positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits.
measure
EFS in High Risk APL Patients
time Frame
Up to 24 months

Full study description

brief Summary: This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.
detailed Description: PRIMARY OBJECTIVES: I. To eliminate exposure to conventional chemotherapy (including anthracyclines), for patients with standard risk acute promyelocytic leukemia (APL), through use of arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) (tretinoin) based therapy while achieving an event free survival (EFS) that is not inferior compared to historical controls. II. To significantly reduce exposure to conventional chemotherapy, and in particular, anthracycline exposure, for patients with high risk APL, through use of ATO and ATRA based therapy while achieving an event free survival that is not inferior compared to historical controls. EXPLORATORY OBJECTIVES: I. To analyze the clinical impact of FMS-like tyrosine kinase 3 (FLT3) mutations in pediatric APL. II. To correlate clinical outcomes with the kinetics of reduction in promyelocytic leukemia (PML)/retinoic acid receptor alpha (RARalpha) transcript level by quantitative real-time (RT)-polymerase chain reaction (PCR) (RQ-PCR) in bone marrow and peripheral blood samples from diagnosis to time points during therapy. III. To monitor incidence of coagulopathy complications, utilizing standardized conventional supportive care, and correlate with a battery of coagulation testing. IV. To evaluate the neurocognitive outcomes of patients treated on this protocol using patient-completed, performance-based measures of neuropsychological functioning and parent questionnaire report. OUTLINE: INDUCTION THERAPY: Patients with standard and high risk APL receive tretinoin orally (PO) twice daily (BID) and arsenic trioxide intravenously (IV) over 2-4 hours on days 1-28. High risk APL patients also receive dexamethasone PO or IV BID on days 1-14 and idarubicin IV over 15 minutes on days 1, 3, 5, and 7. Patients achieving hematologic complete remission (hCR)/hematologic complete remission with incomplete blood count recovery (hCRi) may go on to consolidation therapy. Patients who do not achieve hCR/hCRi may continue treatment with tretinoin and arsenic trioxide for up to 70 days. CONSOLIDATION THERAPY: Patients receive tretinoin PO BID on days 1-14 and 29-42 and arsenic trioxide IV over 2-4 hours on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 56 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive tretinoin PO BID on days 1-14 and arsenic trioxide IV over 2-4 hours on days 1-5, 8-12, 15-19, and 22-26. MINIMAL RESIDUAL DISEASE (MRD) CONSOLIDATION THERAPY: Patients who have APL in the bone marrow after 2 courses of consolidation therapy receive MRD consolidation therapy prior to continuing onto consolidation course 3. Patients receive cytarabine IV over 1-3 hours every 12 hours on days 1-4; mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6; and tretinoin PO BID on days 1-14. If there are no APL cells in the bone marrow after completion of MRD consolidation therapy, patients continue on to consolidation course 3. After completion of study treatment, patients are followed up monthly for 12 months, every 3 months for 36 months, every 6 months for 48 months, and then annually for 2 years.

Source references

avail Ipds

comment
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
type
Individual Participant Data Set
url
http://nctn-data-archive.nci.nih.gov/

references

citation
Kutny MA, Alonzo TA, Abla O, Rajpurkar M, Gerbing RB, Wang YC, Hirsch BA, Raimondi S, Kahwash S, Hardy KK, Hardy S, Meshinchi S, Gamis AS, Kolb EA, Feusner JH, Gregory J Jr. Assessment of Arsenic Trioxide and All-trans Retinoic Acid for the Treatment of Pediatric Acute Promyelocytic Leukemia: A Report From the Children's Oncology Group AAML1331 Trial. JAMA Oncol. 2022 Jan 1;8(1):79-87. doi: 10.1001/jamaoncol.2021.5206.
pmid
34762093
type
DERIVED

Source notices and limitations

Discovery and provenance

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ther than relapse risk (standard risk, 0 of 66 patients vs. high risk, 4 of 35 patients).[<a href="#cit/section_5.9">9</a>] In the COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trial, patients were treated with tretinoin and arsenic trioxide along with aggressive supportive care measures. There was only 1 d
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(standard risk, 0 of 66 patients vs. high risk, 4 of 35 patients).[<a href="#cit/section_5.9">9</a>] In the COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trial, patients were treated with tretinoin and arsenic trioxide along with aggressive supportive care measures. There was only 1 death (standard-risk APL
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en the risk groups.[<a href="#cit/section_5.3">3</a>] In the COG <a href="/clinicaltrials/NCT00866918">AAML0631 (NCT00866918)</a> and <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trials, relapse risk after remission induction was 4% and 2% overall, respectively.[<a href="#cit/section_5.3">3</a>,<a href="#cit
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href="#cit/section_5.3">3</a>] In the COG <a href="/clinicaltrials/NCT00866918">AAML0631 (NCT00866918)</a> and <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trials, relapse risk after remission induction was 4% and 2% overall, respectively.[<a href="#cit/section_5.3">3</a>,<a href="#cit/section_5.9">9</a>] <
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f the patients experienced a CNS relapse with intrathecal treatment during induction and prophylactic doses during therapy. In the COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> study, CSF exams were deferred if the patient did not have CNS symptoms or hemorrhage. Only 5 of 141 children without a history of
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ced a CNS relapse with intrathecal treatment during induction and prophylactic doses during therapy. In the COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> study, CSF exams were deferred if the patient did not have CNS symptoms or hemorrhage. Only 5 of 141 children without a history of CNS hemorrhage were dia
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.16">16</a>]</p> <p id="_2122" tabindex="-1">Results from the completed cooperative group trial (Children's Oncology Group [COG] <a href="/clinicaltrials/NCT02339740">AAML1331 [NCT02339740]</a>) verified the benefit of treatment with tretinoin and arsenic trioxide for children with newly diagnosed APL,[<a href="#cit/section
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<p id="_2122" tabindex="-1">Results from the completed cooperative group trial (Children's Oncology Group [COG] <a href="/clinicaltrials/NCT02339740">AAML1331 [NCT02339740]</a>) verified the benefit of treatment with tretinoin and arsenic trioxide for children with newly diagnosed APL,[<a href="#cit/section_8.3">3</a>] similar to
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on_8.20">20</a>,<a href="#cit/section_8.21">21</a>]</p> <p id="_1182" tabindex="-1"> Based on data from adult trials and the COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trial, maintenance therapy is likely unnecessary for patients with APL who are treated with tretinoin and arsenic trioxide.[<a href
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="#cit/section_8.21">21</a>]</p> <p id="_1182" tabindex="-1"> Based on data from adult trials and the COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trial, maintenance therapy is likely unnecessary for patients with APL who are treated with tretinoin and arsenic trioxide.[<a href="#cit/section_8.3">3</
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ive arsenic trioxide in the predecessor clinical trial (APML3).</li></ul></div></li><li>The historically controlled noninferiority COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trial was conducted between 2015 and 2019. The study included pediatric patients (age range, 1–21 years) with APL. The study
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the predecessor clinical trial (APML3).</li></ul></div></li><li>The historically controlled noninferiority COG <a href="/clinicaltrials/NCT02339740">AAML1331 (NCT02339740)</a> trial was conducted between 2015 and 2019. The study included pediatric patients (age range, 1–21 years) with APL. The study examined whether the ad
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Childhood Acute Promyelocytic Leukemia Treatment (PDQ®)–Health Professional Version
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Updated: June 14, 2024
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June 14, 2024
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https://www.cancer.gov/types/leukemia/hp/child-aml-treatment-pdq/childhood-apl-treatment-pdq

Preserved source evidence · Not medical advice