Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia



Status:Recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:10 - Any
Updated:11/16/2018
Start Date:October 5, 2011
End Date:October 31, 2019
Contact:Kiran Naqvi
Email:knaqvi@mdanderson.org
Phone:713-745-5073

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Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

This phase II trial studies how well tretinoin and arsenic trioxide with or without
gemtuzumab ozogamicin works in treating patients with previously untreated acute
promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide,
work in different ways to stop the growth of cancer cells, either by killing the cells, by
stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as
gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal
cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill
more cancer cells.

PRIMARY OBJECTIVES:

I. Assess whether a combination of all-trans retinoic acid (ATRA [tretinoin]), and arsenic
trioxide (ATO) can produce long-term event-free survival in patients with low-risk untreated
acute promyelocytic leukemia (APL).

II. Assess whether administration of gemtuzumab ozogamicin (GO) at the diagnosis in patients
with high-risk APL (white blood cell [WBC] > 10,000) and if the WBC rises to > 10,000 after
start of treatment (in patients with low-risk disease) will improve complete response (CR)
rate without increasing toxicity in high-risk untreated APL.

OUTLINE:

INDUCTION: Patients receive tretinoin orally (PO) twice daily (BID), arsenic trioxide
intravenously (IV) over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at
weeks 1-4.

CONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks
1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment
repeats every 8 weeks for up to 4 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 6-12 months.

Inclusion Criteria:

- A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by
cytogenetics, polymerase chain reaction (PCR), or POD test

- Ability to understand and the willingness to sign a written informed consent document
indicating that they are aware of the investigational nature of the study

- Patients in whom therapy for APL was initiated on an emergent basis are eligible
(patients may have already started treatment with ATRA, ATO, and/or one dose of
idarubicin due to the urgency to start therapy early)

- Women of child-bearing potential must have a negative serum pregnancy test at
screening; in addition to having a negative pregnancy test confirmed at screening, all
female participants of childbearing potential must have a negative pregnancy test
confirmed within 48 hours prior to dosing with the study drug

- All sexually active subjects (males and females of child-bearing potential) agree to
use 2 effective methods of contraception for the duration of the study

Exclusion Criteria:

- Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than
480 milliseconds

- Patients with creatinine > 2.5 times upper limit of normal unless felt to be related
the underlying leukemia by the treating physician or hemolysis or Gilbert's disease

- Patients with total bilirubin >= 2.0 times upper limit of normal unless felt to be
related the underlying leukemia by the treating physician or hemolysis or Gilbert's
disease

- Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 3
times upper limit of normal unless felt to be related the underlying leukemia by the
treating physician or hemolysis or Gilbert's disease
We found this trial at
5
sites
Nassau Bay, Texas 77058
Principal Investigator: Kiran Naqvi
Phone: 713-745-5073
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Houston, Texas 77030
Principal Investigator: Kiran Naqvi
Phone: 713-745-5073
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Houston, TX
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Houston, Texas 77094
Principal Investigator: Kiran Naqvi
Phone: 713-745-5073
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Houston, TX
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Sugar Land, Texas 77478
Principal Investigator: Kiran Naqvi
Phone: 713-745-5073
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Sugar Land, TX
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The Woodlands, Texas 77384
Principal Investigator: Kiran Naqvi
Phone: 713-745-5073
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The Woodlands, TX
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