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Bendamustine in Acute Leukemia and MDS
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Cephalon
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00790855
  Purpose

The goal of the Phase I part of this clinical research study is to find the highest safe dose of bendamustine that can be given to patients with AML, ALL, CML in blastic phase, CMML, and MDS.

The goal of the Phase II part of this clinical research study is to learn if bendamustine can help to control AML, ALL and MDS. The safety of this drug will continue to be studied.

Optional Procedures: You will be asked to allow additional blood to be drawn to measure the effect of bendamustine on DNA (the genetic material of cells), for pharmacokinetic (PK) testing, and for pharmacodynamic (PD) testing. PK testing measures the amount of study drug in the body at different time points. PD testing is used to look at how the level of study drug in your body may affect the disease.


Condition Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Drug: Bendamustine
Phase I
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Bendamustine Bendamustine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Phase I: To determine the toxicities and maximum tolerated dose (MTD) of bendamustine when administered intravenously (IV) over 1-2 hours BID for 4 days in patients with acute leukemia and high-risk myelodysplastic syndrome (MDS). [ Time Frame: May 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase II: Evaluate anti-tumor activity and safety in acute myeloid leukemia (AML), 2) MDS, and 3) acute lymphoid leukemia (ALL). [ Time Frame: May 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 153
Study Start Date: May 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bendamustine: Experimental
Arm 1
Drug: Bendamustine
Bendamustine 50mg/m2 IV over 1-2 hours twice daily (about every 12 hours ± 3 hours) x 4 days every 4 weeks. Therapy can start earlier (e.g. every 3 weeks) if evidence of persistent or progressive disease.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be 16 years of age or older.
  • 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 WHO classification (see Appendix G)] 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.
  • 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.
  • ECOG performance status of 0-3.
  • 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 administered.
  • Must be able and willing to give written informed consent.
  • 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.
  • Patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1) Serum creatinine </= 2.0 mg/dl; 2) Total bilirubin </= 1.5x the upper limit of normal unless considered due to Gilbert's syndrome; 3) Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) </= 3x the upper limit of normal unless considered due to organ leukemic involvement.
  • Patients with active CNS disease are included and will be treated concurrently with intrathecal therapy.
  • 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:

  • 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.
  • Active heart disease including myocardial infarction within previous 3 months, unstable angina, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Patients with NYHA class 3 or 4 are excluded.
  • Patients receiving any other standard or investigational treatment for their hematologic malignancy, except as permitted under Inclusion #9 above.
  • Pregnant or breast feeding females are excluded because the effects of bendamustine on a fetus or nursing child are unknown.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790855

Contacts
Contact: Hagop M. Kantarjian, M.D. 713/792-7026 hkantarj@mdanderson.org

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Hagop M Kantarjian, MD     713-792-7026     hkantarj@mdanderson.org    
Principal Investigator: Hagop M. Kantarjian, M.D.            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
Principal Investigator: Hagop M. Kantarjian, M.D. M.D. Anderson Cancer Center
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: The University of Texas M.D. Anderson Cancer Center ( Hagop Kantarjian M.D./Professor )
Study ID Numbers: 2007-0634
Study First Received: November 13, 2008
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00790855  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Bendamustine
Acute Leukemia
Leukemia
Acute myeloid leukemia
Myelodysplastic Syndrome
Acute lymphoblastic leukemia
Chronic myeloid leukemia
MDS
ALL
AML
CML

Study placed in the following topic categories:
Myelodysplastic syndromes
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Chronic myelogenous leukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Acute myelogenous leukemia
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders
Acute myelocytic leukemia
Lymphoma
Bendamustine

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009