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Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)


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

Thank you

Trial Information

Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)


Study Drug Administration:

If you are eligible to take part in this study, you will receive 1 or 2 cycles of induction
therapy followed by up to 17 cycles of consolidation therapy. Each study cycle is 4 weeks.

Induction Cycles:

On Days 1-5, you will receive cladribine by vein over 1-2 hours.

On Days 1-10, you will give yourself the cytarabine by injection twice a day about 12 hours
apart. You will receive instructions on how give yourself the injections.

You may receive up to 2 cycles at this dose and schedule.

Consolidation Cycles:

Consolidation cycles will begin on Cycle 2 regardless of how many cycles you received of
induction therapy.

During Cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18:

- On Days 1-3, you will receive cladribine by vein over 1-2 hours.

- On Days 1-10, you will give yourself cytarabine by injection twice daily starting 3 to
6 hours after the start of the cladribine infusion.

Cycles 3, 4, 7, 8, 11, 12, 15, and 16:

-On Days 1-5, you will receive decitabine by vein over 1-2 hours each day.

Study Visits:

On Day 1 of every cycle:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

On Day 21 (+/- 7days) of the induction cycle, you may have a bone marrow aspirate to check
the status of the disease. After that, you will have a bone marrow aspirate every 2 weeks
(or more often if your doctor feels it is necessary). If your routine blood tests show that
there is still leukemia, you may not need to have the bone marrow samples collected.

Blood (about 1-2 teaspoons) will be drawn for routine tests at least 1 time weekly until
remission, then every 2-4 weeks during treatment, the every 4-8 weeks while you are on the
study.

Length of Treatment:

You may continue taking the study drugs for up to 18 cycles. You will no longer be able to
take the study drug 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 when you have completed follow-up.

Follow-Up Visits:

When you are off treatment, every 6 -12 months you will be contacted by a member of the
study staff. You will be asked about any side effects you may be having. The phone calls
will take about 5-10 minutes. You will continue to be called for as long as possible.

This is an investigational study. Cladribine is FDA approved and commercially available for
use in patients with hairy cell leukemia. Its use in patients with AML is investigational.

Cytarabine is FDA approved and commercially available for use in patients with AML.

Decitabine is FDA approved and commercially available for use in patients with MDS. Its use
for patients with AML is investigational.

Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients with previously untreated AML or high risk MDS (>/= 10 % blasts or IPSS >/=
intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors,
azacytidine, ATRA, or an isolated dose of cytarabine up to 2g is allowed. Patients
with history of MDS transformed to AML are eligible regardless of their prior therapy
for MDS provided this will be their first induction therapy for AML.

2. Age >/= 60 years. Patients aged < 60 years who are unsuitable for standard induction
therapy may be eligible after discussion with PI

3. Adequate organ function as defined below: liver function (bilirubin and/or ALT
4. ECOG performance status of
5. A negative urine pregnancy test is required within 1 week for all women of
childbearing potential prior to enrolling on this trial.

6. Patient must have the ability to understand the requirements of the study and signed
informed consent. A signed informed consent by the patient or his legally authorized
representative is required prior to their enrollment on the protocol.

7. Prior therapy with decitabine will be allowed unless the patient experienced
progression to AML while being treated with decitabine.

Exclusion Criteria:

1. Pregnant women are excluded from this study because the agents used in this study
have the potential for teratogenic or abortifacient effects. Because there is a
potential risk for adverse events in nursing infants secondary to treatment of the
mother with the chemotherapy agents, breastfeeding should also be avoided.

2. Uncontrolled intercurrent illness including, but not limited to ongoing or active
uncontrolled infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.

3. Patient with documented hypersensitivity to any of the components of the chemotherapy
program.

4. Men and women of childbearing potential who do not practice contraception. Women of
childbearing potential and men must agree to use contraception prior to study entry
and for the duration of study participation.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-Free Survival (DFS)

Outcome Description:

Disease-free survival (DFS) defined as the time interval from treatment start until clinically significant disease progression or death, whichever occurred first. Participants followed for survival every 6 to 12 months after completion of active treatment. Study continuously monitored for primary endpoint, DFS using the method of Thall, Wooten, and Tannir.

Outcome Time Frame:

Day 21

Safety Issue:

No

Principal Investigator

Tapan Kadia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0987

NCT ID:

NCT01515527

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Leukemia
  • Leukemia
  • Acute myeloid leukemia
  • AML
  • myelodysplastic syndrome
  • MDS
  • Cytarabine
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride
  • Decitabine
  • Dacogen
  • Cladribine
  • Leustatin
  • 2-CdA
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030