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


Phase 2
10 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

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


Study Drugs:

ATRA and ATO are designed to cause the APL cells to mature and function normally. ATO also
kills leukemia cells directly.

GO is designed to attach to CD33, a certain protein that is often found in leukemia cells,
causing them to die.

Study Drug Administration

Induction:

If you are found to be eligible to take part in this study, you will begin Induction. This
is called Course 1. During Induction, you will take ATRA by mouth 2 times a day, starting on
Day 1. You will also receive ATO through a needle in your vein every day, starting on Day
1. You will continue receiving the drugs until your bone marrow no longer shows APL cells.
This is called complete remission (CR).

Some time during Weeks 1-4, you may be given GO one time by vein, over about 2 hours.

You will receive methylprednisolone by mouth or by vein once a day for 5 days to help
prevent side effects. If by vein, the infusion will take about 30 minutes.

If you stop taking either ATRA or ATO because of side effects, you may continue to receive
GO every 4 to 5 weeks until you have been in complete remission for 28 weeks.

Consolidation:

Within 1 week after the disease is in CR, the consolidation treatment will begin.

- You will receive ATO by vein for 5 days total during Weeks 1-4 of Courses 2-5. Each
course is about 8 weeks.

- You will take ATRA by mouth twice a day during Weeks 1-2 and 5-6 of Courses 2-5.

- If your study doctor thinks it is needed, you may receive GO by vein over about 1 hour.
You will receive 2 doses about 5 weeks apart.

- Your doctor may change your dose or schedule if it is in your best interest.

- If your study doctor agrees, you may have the consolidation treatment given by your
home doctor. Your home doctor will be contacted by the research staff and will be
provided with the treatment details. Your home doctor will be asked to perform the
physical exam and blood work at his/her office, and will be asked to send laboratory
reports back to the research nurse. You will be asked to return to MD Anderson every 3
months for follow-up visits.

Study Visits:

Before each course of treatment, you will have a physical exam.

- At each visit, you will be asked about any side effects you may be having and any drugs
you may be taking.

- On Days 1-7 of Course 1, blood (about 1 tablespoon) will be drawn for routine tests.
Blood will then be drawn 2 times a week until the disease is in CR.

- If you are able to become pregnant, you will have a blood (about ½ teaspoon) or urine
pregnancy test within 48 hours before taking the first dose of GO. To take part in this
study, you cannot be pregnant.

- You will have a bone marrow aspirate collected on Day 21-28 of Course 1 to check the
status of your disease. If your doctor thinks it is needed, you may have a bone marrow
aspirate collected every 7-10 days until your blood cell counts return to a certain
level.

- Once the disease is in CR, blood (about 1 tablespoon) will be drawn before you receive
every round of ATO and every round of GO, and at least every week during Weeks 1-4 of
Courses 2-5.

- You will have an ECG before you receive ATO during Weeks 1-4 of Courses 1-5.

Length of Study:

You may continue taking the study drugs for up to 4 consolidation courses. You will no
longer be able to take the study drug if the disease gets worse, if intolerable side effects
occur, you do not respond to the study drugs, or if you are unable to follow study
directions.

Your participation on the study will be over once you have completed the long-term follow
up.

End-of-Treatment Visit:

- You will have an end of treatment visit within 1 month after the last dose of any study
drug. The following procedures will be performed:

- You will have a physical exam.

- You will be asked about any side effects you may be having and any drugs you may be
taking.

- Blood (about 1 tablespoon) will be drawn for routine tests.

Follow-up Visits:

- You will have a bone marrow aspiration to look for any remaining disease every 3 (+/-1)
months.

- At each visit, you will be asked about any side effects you may be having and any drugs
you may be taking.

Long-Term Follow-up Visits:

You will be contacted every 6-12 months by telephone call, regular mail, or e-mail to check
the status of the disease. If contacted by phone, the call should last about 10 minutes.

This is an investigational study. ATRA and ATO are FDA approved and commercially available.
GO is not FDA approved or commercially available. At this time, it is being used for
research purposes only.

Up to 100 patients will take part in the study. All will be enrolled at MD Anderson.


Inclusion Criteria:



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

2. 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.

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

4. Patients age 10 years and older are eligible.

5. 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.

6. 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:

1. Corrected QT Interval (QTc) interval on the electrocardiogram (EKG or ECG) greater
than 480 milliseconds by any correction.

2. Patients with creatinine > 2.5 and total bilirubin >/= 2.0 and aspartate
aminotransferase / alanine aminotransferase (AST/ALT) > 3 times upper limit of normal
unless felt to be related the underlying leukemia by the treating physician or
hemolysis or Gilbert's disease.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event Free Survival (EFS)

Outcome Description:

Time from start of treatment to first documentation of disease relapse or death. For each risk group, Bayesian time-to-event model used to monitor the event free survival (EFS) time.

Outcome Time Frame:

Day 21-28

Safety Issue:

No

Principal Investigator

Farhad Ravandi-Kashani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0981

NCT ID:

NCT01409161

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Leukemia
  • Leukemia
  • Acute Promyelocytic Leukemia
  • APL
  • ATRA
  • Tretinoin
  • All-trans retinoic acid
  • Vesanoid
  • ATO
  • Arsenic trioxide
  • Trisenox
  • GO
  • Gemtuzumab
  • Mylotarg
  • Gemtuzumab ozogamicin
  • Methylprednisolone
  • Depo-Medrol
  • Medrol
  • Solu-Medrol
  • Leukemia
  • Leukemia, Promyelocytic, Acute

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030