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Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS)

Phase 1/Phase 2
16 Years
Not Enrolling
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia

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Trial Information

Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS)

The Study Drug:

Bendamustine is designed to damage and destroy the DNA of cancer cells.

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 joined this study. Up to 60 participants will be enrolled in the
Phase I portion of the study, and up to 3 groups of 31 participants will be enrolled in
Phase II.

If you are enrolled in the Phase I portion, the dose of bendamustine you receive will depend
on when you joined this study. The first group of participants will receive the lowest dose
level of bendamustine. Each new group will receive a higher dose of bendamustine than the
group before it, if no intolerable side effects were seen. This will continue until the
highest tolerable dose of bendamustine is found.

If you are enrolled in the Phase II portion, you will receive bendamustine at the highest
dose that was tolerated in the Phase I portion.

Study Drug Administration:

You will receive bendamustine through a needle or catheter in your vein over 2 hours twice
on Days 1-4 of every 4 week study cycle. You will begin a new study cycle when your blood
cell counts have returned to an appropriate level. You may begin a new study cycle earlier
if your disease gets worse or does not improve.

Study Visits:

Blood (about 2 tablespoons) will be drawn for routine tests every 3-7 days during Cycle 1,
and then every 1-2 weeks during all other cycles.

A bone marrow aspirate will be performed to check the status of the disease after Cycle 1
and every 3-4 Cycles thereafter, or as needed to document response.

Length of Study:

You may remain on study for as long as you are benefitting. You will be taken off study
early if the disease gets worse or intolerable side effects occur.

This is an investigational study. Bendamustine is not FDA approved or commercially
available in the United States. At this time, bendamustine is only being used in research.

Up to 153 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients will be 16 years of age or older.

2. Patients must have relapsed/refractory leukemias for which no standard therapies are
anticipated to result in a durable remission (longer than 3 months). Patients with
poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or
RAEB-2) by World Health Organization (WHO) classification] and chronic myelomonocytic
leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias
include acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or chronic
myelogenous leukemia (CML) in blastic phase.

3. Continued from #2: Elderly patients with AML who are not eligible for frontline
standard therapy, or who refuse to be treated with intensive chemotherapy, may be
eligible. The phase II portion of the study will enroll patients with AML, MDS, and
ALL. Patients with CML and CMML will not participate in the phase II portion of the
study. Patients who are being considered for stem cell transplant are also eligible
for this protocol.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.

5. Women of child-bearing potential (i.e., woman has not been naturally postmenopausal
for at least 24 consecutive months or not surgically sterile) must use acceptable
contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or
double barrier device), and must have a negative serum or urine pregnancy test within
2 weeks prior to beginning treatment on this trial. Sexually active men must also use
acceptable contraceptive methods for the duration of time on study. Men and women
must maintain effective contraception until 4 weeks after the last dose of drug is

6. Must be able and willing to give written informed consent.

7. In the absence of rapidly progressing disease, the interval from prior treatment to
time of study drug administration should be at least 2 weeks for cytotoxic agents, or
at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to
control peripheral blood leukemic cell counts, the patient must be off hydroxyurea
for at least 24 hours before initiation of treatment on this protocol. Persistent
clinically significant toxicities (any grade 2 or worse toxicities, non-hematologic
or hematologic) from prior chemotherapy must not be greater than Grade 1.

8. Patients must have the following clinical laboratory values unless considered due to
leukemic organ involvement: 1) Serum creatinine 1.5 times the upper limit of normal unless considered due to Gilbert's syndrome; 3)
Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) upper limit of normal unless considered due to organ leukemic involvement.

9. Patients with active Central Nervous System (CNS) disease are included and will be
treated concurrently with intrathecal therapy.

10. Phase II Portion: All above criteria apply. After the phase I portion, patients
eligibility will be for only 3 disease categories which will accrue in parallel: 1)
AML, 2) MDS, and 3) ALL.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to uncontrolled
infection (i.e. persistent fever, clinical deterioration), acute congestive heart
failure and exacerbation, cardiac arrhythmia, chronic liver disease, or psychiatric
illness/social situations that would limit compliance with study requirements.

2. Active heart disease including myocardial infarction within previous 3 months,
unstable angina, arrhythmias not controlled by medication, or uncontrolled congestive
heart failure. Patients with New York Heart Association (NYHA) class 3 or 4 are

3. Patients receiving any other standard or investigational treatment for their
hematologic malignancy, except as permitted under Inclusion #9 above.

4. Pregnant or breast feeding females are excluded because the effects of bendamustine
on a fetus or nursing child are unknown.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.

Outcome Time Frame:

During course 1 (4 week cycle)

Safety Issue:


Principal Investigator

Hagop M. Kantarjian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

March 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Acute Lymphoblastic Leukemia
  • Chronic Myeloid Leukemia
  • Bendamustine
  • Acute Leukemia
  • Leukemia
  • Acute myeloid leukemia
  • Myelodysplastic Syndrome
  • Acute lymphoblastic leukemia
  • Chronic myeloid leukemia
  • MDS
  • ALL
  • AML
  • CML
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia



UT MD Anderson Cancer Center Houston, Texas  77030