Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01088984
First received: March 16, 2010
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

The primary objective of part 1 of this study is to establish the recommended pediatric dose. The primary objective of part 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended pediatric dose for the treatment of pediatric patients with relapsed or refractory acute leukemia.


Condition Intervention Phase
Leukemia
Drug: Bendamustine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Overall response rate (ORR) of bendamustine. ORR includes complete remission (CR) and complete remission without platelet recovery (CRp). [ Time Frame: Day 21 of the Induction Cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the pharmacokinetic profile of bendamustine and its metabolites in this pediatric population. [ Time Frame: Days 1 and 2 of the Induction Cycle ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine
Bendamustine administered on days 1 and 2 of each cycle (maximum of 12 total cycles).
Drug: Bendamustine
Bendamustine administered as an iv infusion over 60 minutes on days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.

  Eligibility

Ages Eligible for Study:   1 Year to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • The patient has histologically proven acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) that has relapsed or is refractory to the last regimen, and the patient is without alternative curative therapy.
  • The patient's last myelosuppression therapy ended at least 2 weeks before the first dose of study drug.
  • Nonhematologic acute toxic effects of prior therapy have resolved to grade 2 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
  • The patient has adequate liver function with bilirubin values less than or equal to 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values less than or equal to 5 times the age-appropriate ULN.
  • The patient has adequate renal function with serum creatinine values less than 2 times ULN.
  • The patient has Karnofsky or Lansky performance status of 60 or greater. Patients older than 16 years of age will be scored according to the Karnofsky scale and patients 16 years of age or younger will be scored according to the Lansky scale.
  • The patient may have had hematopoietic stem cell transplantation.
  • Women of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
  • Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Key Exclusion Criteria:

  • The patient has any active, uncontrolled systemic infection, severe concurrent disease, or symptomatic untreated central nervous system (CNS) involvement.
  • The patient has evidence of active graft versus host disease.
  • The patient has a known human immunodeficiency virus (HIV) infection.
  • The patient has active hepatitis B or hepatitis C infection.
  • The patient is a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study immediately.
  • The patient has any serious uncontrolled medical or psychological disorder that would impair the ability of the patient to receive study drug.
  • The patient has any condition that places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
  • The patient has received any other investigational agent within 30 days of study entry.
  • The patient has known hypersensitivity to bendamustine or mannitol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088984

  Hide Study Locations
Locations
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Florida
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Mississippi
The University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17110
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
Cook Children's Hospital
Fort Worth, Texas, United States, 76104
United States, Washington
Childrens Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
United States, Wisconsin
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Children's Hospital - Brisbane
Herston, Queensland, Australia, 4029
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Belarus
Republican Center of Children Oncology and Hematology
Minsk, Belarus, 223040
Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, Brazil, 81520-060
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90020-090
Hospital de Clinicas de Porto Alegre
Porto Alegre-RS, Brazil, 90035-903
Hospital das Clinicas da Faculdade de Medicina da Universida
Sao Paulo, Brazil, 5403000
Graacc-Grupo de Apoio ao Adolescente
Sao Paulo, Brazil, 04023-062
Hospital Santa Marcelina
Sao Paulo-SP, Brazil, 08270-070
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1L7
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Schneider Children's Medical Center of Israel
Petach Tikva, Israel, 49100
Chaim Sheb Medical Center
Tel HaShomer, Israel, 52620
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138736
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137701
Seoul National University Hospital
Seoul, Korea, Republic of, 110744
Mexico
Hospital Universitario - Dr. José Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Instituto Nacional de Pediatria Insurgentes
Mexico City, Mexico, 4530
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico, 6720
Hospital Universitario Avenida Francisco I. Madero Poniente
Monterrey, Mexico, 64460
Poland
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Bialystok, Poland, 15-274
Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebali
Lublin, Poland, 20-093
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warszawa, Poland, 02-672
Russian Federation
Federal Research Center of Pediatric Hematology
Moscow, Russian Federation, 117997
Children's City Hospital #1
St. Petersburg, Russian Federation, 198205
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01088984     History of Changes
Other Study ID Numbers: C18083/2046, 2010-020768-40
Study First Received: March 16, 2010
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belarus: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Israel: Israeli Health Ministry Pharmaceutical Administration
Mexico: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
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 July 28, 2014