Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
First received: March 16, 2010
Last updated: March 20, 2013
Last verified: March 2013
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.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
Bendamustine administered on days 1 and 2 of each cycle (maximum of 12 total cycles).
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.
|Ages Eligible for Study:
||1 Year to 20 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088984
||Sponsor's Medical Expert
No publications provided
||Teva Pharmaceutical Industries ( Cephalon )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 16, 2010
||March 20, 2013
||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:
ClinicalTrials.gov processed this record on May 21, 2013
Neoplasms by Histologic Type
Nitrogen Mustard Compounds
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action