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A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome


Phase 2
12 Years
N/A
Not Enrolling
Both
Leukemia, AML, MDS, CML

Thank you

Trial Information

A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome


The Study Drugs Fludarabine is designed to make cancer cells less able to repair damaged DNA
(the genetic material of cells). This may increase the likelihood of the cells dying.

Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive fludarabine and
cytarabine.

During each cycle (about 4-6 weeks), you will receive the study drugs for up to 5 days and
you will be watched by the study staff for about 1 month.

Induction (Cycle 1):

For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive fludarabine by vein over
15-30 minutes 2 times a day (about every 12 hours).

For 3, 4, or 5 days during Days 1-5 of Cycle 1, you will receive cytarabine by vein over
about 2 hours 2 times a day (about every 12 hours).

If the cancer does not completely respond after Cycle 1, you may repeat induction (Cycle 1).

If the cancer completely responds, you will begin the consolidation cycles.

Consolidation (Cycles 2-7):

For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive fludarabine by vein over
15-30 minutes 2 times a day (about every 12 hours).

For 3 or 4 days during Days 1-4 of Cycles 2-7, you will receive cytarabine by vein over
about 2 hours 2 times a day (about every 12 hours).

Study Visits:

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

During Induction Therapy (Cycle 1):

- Blood (about 2 tablespoons) will be drawn for routine tests every 3-7 days.

- About Day 28, you may have a bone marrow aspirate to check the status of the disease.

During Consolidation Therapy (Cycles 2-7):

- Blood (about 2 tablespoons) will be drawn for routine tests every 1-2 weeks.

- You will have a bone marrow aspirate every 2-3 cycles to check the status of the
disease.

Length of Study:

You will be able to receive the study drugs for up to about 8 months. You will be taken off
study treatment if you have intolerable side effects, if the disease gets worse, or if the
study doctor thinks it is in your best interest.

Long-Term Follow-Up:

Every 3 months for 2 years after you are off study treatment, you will be called and asked
how you are feeling, about any side effects you may be having, and about another other drugs
you may be taking.

Supportive Care:

Please talk with your doctor about drugs that you can or cannot take while you are on study.

This is an investigational study. Cytarabine is FDA approved and commercially available as
a frontline (first) treatment for AML. Fludarabine is FDA approved and commercially
available for the treatment of CLL.

The combination of these 2 drugs to treat AML, MDS, or CML in myeloid blast crisis is
investigational.

Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Sign an IRB-approved informed consent document.

2. Age >/= 12 years.

3. Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with
refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if
not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2
or high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic
myeloid leukemia (CML) in blast crisis will be eligible as well.

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

6. Women of childbearing potential (WCBP) 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. Pregnant or breastfeeding females.

2. Diagnosis of acute promyelocytic leukemia (M3).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Patients Response Rate

Outcome Time Frame:

Following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7). Cycle is 4-6 weeks.

Safety Issue:

Yes

Principal Investigator

Elias Jabbour, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0781

NCT ID:

NCT01019317

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Leukemia
  • AML
  • MDS
  • CML
  • Acute Myelogenous Leukemia
  • High-Risk Myelodysplastic Syndrome
  • Chronic myeloid leukemia
  • CML
  • Blast crisis
  • Cytarabine
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride
  • Arabinosine Hydrochloride
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Gemtuzumab Ozogamicin
  • Mylotarg
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030