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

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Brief Title

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

Official Title

Treatment of Acute Promyelocytic Leukemia (APL) With All-Trans Retinoic Acid, and Arsenic +/- Idarubicin

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.
    

Detailed Description

      All-trans retinoic acid (ATRA) and ATO are designed to cause the APL cells to mature and
      function normally. Idarubicin is designed to cause breaks in both strands of DNA (the genetic
      material of cells).

      If you are found to be eligible to take part in this study, you will begin induction. During
      induction, you will receive ATRA, by mouth starting on Day 1. You will also receive ATO
      through a needle in your vein over 2 hours starting on Day 1. You will continue receiving the
      drugs every day until your bone marrow no longer shows APL cells.

      If you had a high white blood cell count at screening, you will receive idarubicin through a
      needle in your vein over about 30 minutes one dose only on any day of Day 1 through 5.

      During induction, blood (about 1-3 tablespoons) will be drawn every day during Week 1, and
      then 2 times a week after that. This blood will be drawn for routine tests.

      During induction (about 21-28 days after beginning treatment), you will have a bone marrow
      aspirate to check the status of the disease. This may be performed more often if the doctor
      thinks it is needed.

      If you achieve a complete remission during the induction phase, you will continue to the
      maintenance phase. During the maintenance phase, you will receive ATO by vein over 2 hours
      Monday-Friday for 4 weeks. After the 4 weeks of receiving the study drug, you will have a
      4-week period "off" (when no study drug is given). ATRA is given by mouth every day for 2
      weeks. This 2 weeks is followed by 2 additional weeks when no study drug will be given. You
      will continue to take ATRA until treatment with ATO is complete.

      During maintenance, blood (about 1-3 tablespoons) will be drawn before every 4-week cycle of
      ATO, and then every week for routine tests. You will also have an ECG before every 4 week
      cycle when you take ATO.

      If you do not achieve a complete remission during induction you will be taken off study.

      If at any point during the study your white blood cell count rises above 10,000, you will
      receive idarubicin by vein over 30 minutes.

      You will remain in the hospital for about the first 7 days of induction. After that, you must
      remain in Houston for the next 3-4 weeks. Once in the maintenance phase, you may be treated
      at home, but must return to M. D. Anderson for study visits.

      After maintenance is complete, you will have follow-up visits for an additional 2 years. If
      at any time during the active study or follow-up the disease gets worse or intolerable side
      effects occur, you will be taken off the study.

      If you had a low or high white blood cell count when you joined the study, you will have
      follow-up visits every 3 months for 2 years. At these visits, blood (about 1 tablespoon) will
      be drawn for routine tests and you will have a bone marrow aspirate.

      This is an investigational study. Idarubicin, ATRA and ATO are FDA approved and commercially
      available. However, their use in this study and in this combination is considered
      investigational. Its use in APL patients is investigational. Up to 80 patients will take part
      in this multicenter study. All will be enrolled at M. D. Anderson.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete Response (CR) Rate


Condition

Acute Promyelocytic Leukemia

Intervention

All-Trans Retinoic Acid (ATRA)

Study Arms / Comparison Groups

 Induction ATRA + ATO + Idarubicin
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

78

Start Date

December 2006

Completion Date

February 2016

Primary Completion Date

February 2016

Eligibility 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Farhad Ravandi-Kashani, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00413166

Organization ID

2006-0706

Secondary IDs

NCI-2012-01395

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center


Study Sponsor

Farhad Ravandi-Kashani, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

April 2019