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Trial record 24 of 144 for:    "Acute promyelocytic leukemia"

All-trans Retinoic Acid, and Arsenic +/- Idarubicin

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ClinicalTrials.gov Identifier: NCT00413166
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : April 18, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if the combination of arsenic trioxide (ATO) with ATRA and possibly idarubicin is effective in treating patients with newly-diagnosed APL.

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Drug: All-Trans Retinoic Acid (ATRA) Drug: Arsenic Trioxide (ATO) Drug: Idarubicin Drug: Gemtuzumab Ozogamicin Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin
Study Start Date : December 2006
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Induction ATRA + ATO + Idarubicin

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO)

ATRA 45 mg/m2 daily by mouth beginning day 1; ATO 0.15 mg/kg by vein daily beginning on day 1; Idarubicin 12 mg/m2 x 1 dose; Methylprednisolone 50 mg daily for 5 days starting on day 1.

Drug: All-Trans Retinoic Acid (ATRA)
Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1

Drug: Arsenic Trioxide (ATO)
Induction: 0.15 mg/kg daily IV beginning day 1

Drug: Idarubicin
  1. 12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
  2. If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.
Other Name: Idamycin

Experimental: Maintenance

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO)

ATO 0.15 mg/kg by vein over 2 hours Monday-Friday for 4 weeks, then a 4-week break. ATRA 45 mg/m2 by mouth every day for 2 weeks, followed by 2 additional weeks of no study drug. Continue ATRA until treatment with ATO complete.

Drug: All-Trans Retinoic Acid (ATRA)
Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1

Drug: Arsenic Trioxide (ATO)
Induction: 0.15 mg/kg daily IV beginning day 1

Drug: Idarubicin
  1. 12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
  2. If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.
Other Name: Idamycin

Experimental: Induction ATRA + ATO + GO

All-Trans Retinoic Acid (ATRA) + Arsenic Trioxide (ATO) + Gemtuzumab Ozogamicin (GO)

ATRA 45 mg/m2 daily po (in 2 divided doses) beginning day 1; ATO 0.15 mg/kg IV daily beginning on day 1; GO 9 mg/m2 on day 1 Methylprednisolone 50 mg daily for 5 days followed by rapid taper starting on day 1.

Theophylline 100mg p.o. bid days 1-3, 200 mg p.o. bid days 4-6, and 300 mg p.o. bid thereafter during periods when patient is receiving ATRA or ATO. Theophylline administration continues until therapy with ATO and ATRA is completed.

Drug: All-Trans Retinoic Acid (ATRA)
Induction: 45 mg/m2 daily by mouth in 2 divided doses beginning day 1

Drug: Arsenic Trioxide (ATO)
Induction: 0.15 mg/kg daily IV beginning day 1

Drug: Idarubicin
  1. 12 mg/m2 one dose only (may be given on day 1 to 5 of induction)
  2. If either ATRA or ATO are discontinued due to toxicity, idarubicin 12 mg/m2 x 2 doses will be administered once every 4 to 5 weeks (depending on the recovery of counts) until 28 weeks has elapsed from the Complete Recovery date.
Other Name: Idamycin

Drug: Gemtuzumab Ozogamicin
Induction: 9 mg/m2 on day 1 of induction




Primary Outcome Measures :
  1. Complete Response (CR) Rate [ Time Frame: 1 month, up to day 85 of treatment ]

    Response defined as CR (marrow with <5% blasts and no abnormal promyelocytes together with neutrophil count >1000 and platelet count >100,000) and toxicity as Acute promyelocytic leukemia (APL) differentiation syndrome, arrhythmia, peripheral neuropathy.

    Bone marrow aspirate performed to check the status of the disease.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene by cytogenetics, PCR, or POD test.
  2. Provision of written informed consent.
  3. Patients in whom therapy for APL was initiated on an emergent basis are eligible

Exclusion Criteria:

  1. First trimester of pregnancy (ATRA is teratogenic)
  2. Corrected QT (QTC) interval must not be greater than 480 milliseconds.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413166


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00413166     History of Changes
Other Study ID Numbers: 2006-0706
NCI-2012-01395 ( Registry Identifier: NCI CTRP )
First Posted: December 19, 2006    Key Record Dates
Results First Posted: April 18, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Keywords provided by M.D. Anderson Cancer Center:
Acute Promyelocytic Leukemia
APL
ATRA
All-Trans Retinoic Acid
Arsenic Trioxide
Theophylline
Gemtuzumab
Additional relevant MeSH terms:
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Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Idarubicin
Arsenic Trioxide
Tretinoin
Gemtuzumab
Theophylline
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Keratolytic Agents
Dermatologic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents