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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any - 21
Updated:2/24/2019
Start Date:June 29, 2015

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A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid

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.

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.

SECONDARY 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.

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
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Principal Investigator: Kamnesh R. Pradhan
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Indianapolis, Indiana 46260
Principal Investigator: Bassem I. Razzouk
Phone: 317-338-2194
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Indianapolis, IN
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Iowa City, Iowa 52242
Principal Investigator: Mariko Sato
Phone: 800-237-1225
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Iowa City, IA
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Jacksonville, Florida 32207
Principal Investigator: Emi H. Caywood
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Jacksonville, FL
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Kansas City, Missouri 64108
Principal Investigator: Keith J. August
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Kansas City, MO
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
Principal Investigator: Ray C. Pais
Phone: 865-541-8266
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Knoxville, TN
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Las Vegas, Nevada 89144
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89135
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Julie Kim
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lexington, Kentucky
Principal Investigator: Vlad C. Radulescu
Phone: 859-257-3379
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Lexington, KY
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: David L. Becton
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert Kheradpour
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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Louisville, Kentucky 40202
Principal Investigator: Ashok B. Raj
Phone: 502-562-3429
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Louisville, KY
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Lubbock, Texas 79430
Principal Investigator: Mohamad M. Al-Rahawan
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Lubbock, TX
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Madera, California 93638
Principal Investigator: Vonda L. Crouse
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Madera, CA
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Kenneth B. De Santes
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Madison, WI
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Marshfield, Wisconsin 54449
Principal Investigator: Michelle A. Manalang
Phone: 800-782-8581
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Marshfield, WI
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Eugene Suh
Phone: 708-226-4357
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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Mesa, Arizona 85202
Principal Investigator: Hardeo K. Panchoosingh
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Mesa, AZ
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Miami, Florida 33136
Principal Investigator: Julio C. Barredo
Phone: 305-243-2647
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Miami, FL
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Miami, Florida 33155
Principal Investigator: Enrique A. Escalon
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Miami, FL
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Michael J. Burke
Phone: 414-955-4727
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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259 1st Street
Mineola, New York 11501
Principal Investigator: Mark E. Weinblatt
Phone: 866-946-8476
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Mineola, NY
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Minneapolis, Minnesota 55455
Principal Investigator: Peter M. Gordon
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Minneapolis, MN
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