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Phase II Trial of Bendamustine in Adult Patients With Acute Lymphoblastic Leukemia/Lymphoma

Phase 2
18 Years
Not Enrolling
Leukemia, Lymphoma

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Trial Information

Phase II Trial of Bendamustine in Adult Patients With Acute Lymphoblastic Leukemia/Lymphoma

Study Drug Administration:

Patient will receive bendamustine by vein over 30 minutes twice a day on Days 1-4 of every
study cycle. The length of each study cycle will depend on how the disease responds to the
study drug. Each cycle will last 3 to 10 weeks.

Study Visits:

Before each cycle, patient will have a physical exam, including measurement of vital signs.

One (1) time each week, blood (about 2 tablespoons) will be drawn for routine tests. These
blood draws will no longer be drawn every week if at any point the disease appears to be
getting better. After that, this blood will only be drawn every 2-4 weeks while patient is
receiving the study drug. These blood draws can be performed by a doctor near the patient
and the results will be reported to the study doctor.

On Day 21 of Cycle 1, then every 4 weeks, patient will have a bone marrow aspirate and/or
biopsy to check the status of the disease. If patient's doctor thinks it is needed, bone
marrow aspirates and/or biopsies may be collected more or less often, depending on the
status of the disease.

Length of Treatment:

Patient may receive up to 12 cycles of the study drug. Patient will be taken off study
early if the disease gets worse, if intolerable side effects occur, or if the study doctor
thinks it is in patient's best interest. Patient's participation in the study will be over
after they complete the follow-up visits.

Follow-up Visits:

Patient will be asked to return to the clinic every 3 to 6 months for up to 5 years after
they stop receiving the study drug. Patient will be asked about any side effects or
symptoms they may be having. If patient is are unable to return to MD Anderson, the
follow-up visits may be conducted over the phone. Each call should last about 5 minutes.

Blood (about 2 tablespoons) will also be drawn for routine tests every 4-8 weeks during this
follow-up period.

This is an investigational study. Bendamustine is FDA approved and commercially available
for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with relapsed/ refractory lymphoid T-cell or B-cell acute lymphoblastic
leukemia which has been previously treated with at least one line of chemotherapy.

2. Age >/= 18

3. Patients must have adequate organ function including adequate renal function
(calculated creatinine clearance >/= 50ml/min calculated per the Cockcroft-Gault
formula). Patients must have adequate hepatic function (AST or ALT < 2.5 x ULN and
total bilirubin < 3X ULN) for the reference lab unless due to leukemia.

4. Patients must have adequate performance status (ECOG 0-3).

5. Female patients must not be pregnant or lactating. Female patients of childbearing
potential must have a negative serum or urine pregnancy test within 2 weeks prior to
study enrollment. Female patients of childbearing potential (including those <1 year
postmenopausal) and male patients must agree to use contraception.

6. Patients must sign an informed consent form indicating that they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.

7. Patients with active CNS involvement of leukemia may be included and treated
concurrently with intrathecal chemotherapy if approved by the PI.

Exclusion Criteria:

1. Patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid
reactions) to bendamustine or mannitol.

2. Patients with untreated or uncontrolled life-threatening infection.

3. Patients known to be HIV positive or known to have Hepatitis B and/or C.

4. Patients must not have received chemotherapy, monoclonal antibody therapy and/or
radiation therapy within 2 weeks of study enrollment unless evidence of rapid disease
progression. Hydroxyurea or corticosteroids for control of blood counts is allowed.

5. Patients must not have any other medical condition, including mental illness or
substance abuse, deemed by the Investigator to be likely to interfere with a
patient's ability to give informed consent or cooperate and participate in the study
or interfere with the interpretation of the results.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

Primary endpoint for evaluating efficacy objective response rate (ORR = complete remission (CR), complete response with no recovery of platelet count > 100 k/mm3 (CRp), complete response criteria with no recovery of absolute neutrophil count greater than 1000/mm3 and/or platelet count > 100 k/mm3 (CRi), partial response (PR). Disease-free survival (DFS) time from date of treatment start until date of first objective documentation of disease-relapse. Overall survival (OS) time from date of treatment start until date of death due to any cause or last follow up.

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Hagop Kantarjian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2012

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Leukemia
  • Lymphoma
  • Acute Lymphoblastic Leukemia/Lymphoma
  • ALL
  • Relapsed or primary refractory B-cell/T-cell
  • Bendamustine
  • Bendamustine Hydrochloride
  • Bendamustine HCL
  • CEP-18083
  • SDX-105
  • Treanda
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma