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Bendamustine in Acute Leukemia and MDS
This study is ongoing, but not recruiting participants.

First Received on November 13, 2008.   Last Updated on May 11, 2011   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: 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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study of Bendamustine in Patients With Acute Leukemia and High-Risk Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Phase I: Dose Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) [ Time Frame: During course 1 (4 week cycle), every 3-7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase II: Response Duration for CR + CRp [ Time Frame: May 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 153
Study Start Date: May 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine Drug: Bendamustine
Starting dose of 50 mg/m^2 through a needle or catheter in vein over 2 hours twice on Days 1-4 of every 4 week study cycle. A new study cycle may begin when blood cell counts have returned to an appropriate level or a new study cycle may begun earlier if disease gets worse or does not improve.
Other Names:
  • Treanda®
  • Bendamustine Hydrochloride
  • Bendamustine HCI
  • CEP-18083
  • SDX-105

  Show Detailed Description

  Eligibility

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

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 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.
  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. 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 administered.
  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 </= 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.
  9. Patients with active 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 NYHA class 3 or 4 are excluded.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790855

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
Principal Investigator: Hagop M. Kantarjian, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Hagop Kantarjian M.D./Professor, The University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00790855     History of Changes
Other Study ID Numbers: 2007-0634
Study First Received: November 13, 2008
Last Updated: May 11, 2011
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012