Bendamustine in Acute Lymphoblastic Leukemia/Lymphoma (ALL)

NCT01649622 | Withdrawn Phase 2

• 1 other identifier: 2012-0345
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Leukemia; Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  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.

  21 days

Study Arms (1)

Bendamustine

EXPERIMENTAL

Patients receive Bendamustine at dose of 75 mg/m2 by vein over 30 minutes twice daily for four days (Days 1-4). Bendamustine dose based on actual body weight. Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses.

Drug: Bendamustine

Interventions

Bendamustine DRUG

75 mg/m2 by vein twice daily for four days (Days 1-4). Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses.

Also known as: Bendamustine Hydrochloride, Bendamustine HCL, CEP-18083, SDX-105, Treanda

Bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age \>/= 18
• 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.
• Patients must have adequate performance status (ECOG 0-3).
• 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.
• 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.
• Patients with active CNS involvement of leukemia may be included and treated concurrently with intrathecal chemotherapy if approved by the PI.

You may not qualify if:

• Patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine or mannitol.
• Patients with untreated or uncontrolled life-threatening infection.
• Patients known to be HIV positive or known to have Hepatitis B and/or C.
• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hagop Kantarjian, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2018
• Last Updated: November 8, 2012

Record last verified: 2012-11