Know Cancer

or
forgot password

An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia


Phase 1/Phase 2
1 Year
20 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR) of bendamustine. ORR includes complete remission (CR) and complete remission without platelet recovery (CRp).

Outcome Time Frame:

Day 21 of the Induction Cycle

Safety Issue:

No

Principal Investigator

Sponsor's Medical Expert

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon

Authority:

United States: Food and Drug Administration

Study ID:

C18083/2046

NCT ID:

NCT01088984

Start Date:

August 2010

Completion Date:

August 2011

Related Keywords:

  • Leukemia
  • Leukemia

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Children's Hospital of MichiganDetroit, Michigan  48201
Children's Hospital of Orange CountyOrange, California  92668
Children's Mercy HospitalKansas City, Missouri  64108
All Children's HospitalSt. Petersburg, Florida  33701
Washington University Medical CenterSaint Louis, Missouri  63105
Oregon Health and Science UniversityPortland, Oregon  97201
Columbia University Medical CenterNew York, New York  10032
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Childrens Hospital of WisconsinMilwaukee, Wisconsin  53201
Rady Children's Hospital San DiegoSan Diego, California  92123
Cook Children's HospitalFort Worth, Texas  76104
The University of Mississippi Medical CenterJackson, Mississippi  39216
Children's Medical Center - DallasDallas, Texas  75390-9063
Childrens Hospital and Regional Medical CenterSeattle, Washington  98105