Bendamustine in Acute Lymphoblastic Leukemia/Lymphoma (ALL)

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if bendamustine can help to control Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.

Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them to die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Bendamustine Hydrochloride

Criteria

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.