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Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia


Phase 1/Phase 2
18 Years
64 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia


Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. Up to 3 groups of 6 participants will be enrolled
in the Phase I portion of the study. Up to 74 participants will be enrolled in Phase II.

Phase I:

If you are enrolled in the Phase I portion, the number of days of clofarabine you receive
will depend on when you joined this study. The first group of participants will receive
clofarabine for the least number of days. Each new group will receive clofarabine for more
days than the group before it, if no intolerable side effects were seen. This will continue
until the highest number of tolerable days of clofarabine is found. The clofarabine dose per
day is the same from group to group.

All participants will receive the same dose level of decitabine, idarubicin and cytarabine.

Phase II:

If you are enrolled in the Phase II portion, you will receive decitabine, idarubicin, and
cytarabine. You will receive clofarabine for the highest number of days that was tolerated
in the Phase I portion.

All participants will receive the same dose level of decitabine, idarubicin, cytarabine, and
clofarabine.

Study Drug Administration:

Each study drug cycle is 33 days. The first cycle of study drugs is called Induction. If
the doctor thinks it is needed, you will have up to 2 Induction cycles.

Phase I (Induction):

On Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1
hour.

On Days 6-10 of each cycle:

- You will receive cytarabine 1 time a day by vein over about 2 hours.

- On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30
minutes.

- You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8, 6-9,
or 6-10, depending on when you join the study.

If the doctor thinks it is needed, your dose level will be reduced after Induction.

If the doctor thinks it is needed, you may receive fewer days of treatment in the Induction
cycle(s).

Phase II (Induction):

On Days 1-5 of each cycle, you will receive decitabine 1 time a day by vein over about 1
hour.

On Days 6-10 of each cycle:

- You will receive cytarabine 1 time a day by vein over about 2 hours.

- On Days 6-8 only, you will receive idarubicin 1 time a day by vein over about 30
minutes.

- You will receive clofarabine 1 time a day by vein over about 1 hour on Days 6-8, 6-9,
or 6-10, depending on the highest number of days clofarabine was tolerated in the Phase
I portion of the study.

If the doctor thinks it is needed, your dose level will be reduced after Induction.

If the doctor thinks it is needed, you may receive fewer days of treatment in the Induction
cycle(s).

Phases I and II (Consolidation):

If the disease responds to the study drugs, you may receive up to 6 more study drug cycles.
This is called Consolidation.

On Days 1-5 of each cycle:

-You will receive decitabine 1 time a day by vein over 1 hour.

On Days 6-8 of each cycle:

- You will receive cytarabine 1 time a day by vein over about 2 hours.

- You will receive clofarabine 1 time a day by vein over about 1 hour.

- On Days 6-7 only, you will receive idarubicin 1 time a day by vein over about 30
minutes.

If the doctor thinks it is needed, you may receive fewer days of treatment in the
Consolidation cycles.

Study Visits:

Before the start of each cycle, you will have a physical exam, including measurement of your
vital signs.

Every 3-7 days, blood (about 2 teaspoons) will be drawn for routine tests.

On Day 33 of every 2-3 cycles (+/- 7 days), if the doctor thinks it is needed, you will have
a bone marrow aspirate to check the status of the disease. To collect a bone marrow
aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is
withdrawn through a large needle.

Length of Treatment:

You may continue taking the study drugs for up to 8 cycles. You will no longer be able to
take the study drugs if the disease gets worse, if intolerable side effects occur, 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.

Long-term Follow-up:

Every 3 months for 1 year after your last study drug dose, the study staff will call you and
ask how you are feeling, about any side effects you may be having, and about any other drugs
you may be taking. These calls should last about 5 minutes each.

This is an investigational study. Decitabine is FDA approved and commercially available to
treat myelodysplastic syndrome (MDS). Clofarabine is FDA approved and commercially available
to treat ALL in children. Idarubicin and cytarabine are FDA approved and commercially
available to treat AML. The study drug combination is investigational.

Up to 92 participants will be enrolled in this study. All will take part at MD Anderson.


Inclusion Criteria:



1. Sign an IRB-approved informed consent document.

2. Age >/= 18 years and <65 years.

3. Diagnosis of AML [other than acute promyelocytic leukemia] with refractory/relapsed
disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE:
Patients with AML arising from prior MDS or MPN would be eligible even if they have
not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would
also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or
up to 4 doses of cytarabine, for emergent cytoreduction is allowed

4. ECOG performance status of
5. Organ function as defined below (unless due to leukemia):Serum creatinine mg/dL;Total bilirubin to disease

6. Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)

7. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days. Men must agree not to father a child and agree to use a condom if his
partner is of child bearing potential.

Exclusion Criteria:

1. Breast feeding women

2. Patients with uncontrolled active infections (viral, bacterial, and fungal are not
eligible).

3. Patients with active secondary malignancy will not be eligible unless approved by the
PI.

4. NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is
allowed, unless the prior therapy is identical to the schema/schedule proposed in
this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) of Clofarabine

Outcome Description:

Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT).

Outcome Time Frame:

After second, 33 day cycle

Safety Issue:

No

Principal Investigator

Nitin Jain, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-1064

NCT ID:

NCT01794702

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Leukemia
  • Leukemia
  • Acute Leukemia
  • Acute myelogenous leukemia
  • AML
  • Acute lymphoblastic leukemia
  • ALL
  • Maximum Tolerated Dose
  • MTD
  • Response Rate
  • Decitabine
  • Dacogen
  • Idarubicin
  • Idamycin
  • Cytarabine
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride
  • Leukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030