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

NCT ID: NCT01088984

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-08-31

Brief Summary

The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bendamustine

Bendamustine 90 or 120 mg/m\^2 administered as an intravenous (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.

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

Interventions

Bendamustine

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sponsor's Medical Expert

Role: STUDY_DIRECTOR

Cephalon

Locations

Teva Investigational Site 17

Orange, California, United States

Teva Investigational Site 12

San Diego, California, United States

Teva Investigational Site 10

St. Petersburg, Florida, United States

Teva Investigational Site 8

Baltimore, Maryland, United States

Teva Investigational Site 16

Boston, Massachusetts, United States

Teva Investigational Site 9

Detroit, Michigan, United States

Teva Investigational Site 1

Jackson, Mississippi, United States

Teva Investigational Site 5

Kansas City, Missouri, United States

Teva Investigational Site 14

St Louis, Missouri, United States

Teva Investigational Site 15

New York, New York, United States

Teva Investigational Site 18

Portland, Oregon, United States

Teva Investigational Site 11

Hershey, Pennsylvania, United States

Teva Investigational Site 7

Philadelphia, Pennsylvania, United States

Teva Investigational Site 19

Memphis, Tennessee, United States

Teva Investigational Site 3

Dallas, Texas, United States

Teva Investigational Site 4

Fort Worth, Texas, United States

Teva Investigational Site 13

Houston, Texas, United States

Teva Investigational Site 2

Seattle, Washington, United States

Teva Investigational Site 6

Milwaukee, Wisconsin, United States

Teva Investigational Site 300

Herston, , Australia

Teva Investigational Site 301

Parkville, , Australia

Teva Investigational Site 302

Randwick, , Australia

Teva Investigational Site 520

Minsk, , Belarus

Teva Investigational Site 615

Barretos-SP, , Brazil

Teva Investigational Site 616

Caxias do Sul, , Brazil

Teva Investigational Site 613

Curitiba-PR, , Brazil

Teva Investigational Site 612

Porto Alegre, , Brazil

Teva Investigational Site 614

Porto Alegre, , Brazil

Teva Investigational Site 617

Sao Paulo-SP, , Brazil

Teva Investigational Site 610

São Paulo, , Brazil

Teva Investigational Site 611

São Paulo, , Brazil

Teva Investigational Site 100

Toronto, , Canada

Teva Investigational Site 501

Jerusalem, , Israel

Teva Investigational Site 503

Petah Tikva, , Israel

Teva Investigational Site 502

Ramat Gan, , Israel

Teva Investigational Site 603

Guadalajara, , Mexico

Teva Investigational Site 600

Mexico City, , Mexico

Teva Investigational Site 601

Mexico City, , Mexico

Teva Investigational Site 602

Monterrey, , Mexico

Teva Investigational Site 303

Auckland, , New Zealand

Teva Investigational Site 531

Bialystok, , Poland

Teva Investigational Site 530

Lublin, , Poland

Teva Investigational Site 532

Warsaw, , Poland

Teva Investigational Site 511

Moscow, , Russia

Teva Investigational Site 510

Saint Petersburg, , Russia

Teva Investigational Site 320

Singapore, , Singapore

Teva Investigational Site 330

Seoul, , South Korea

Teva Investigational Site 331

Seoul, , South Korea

Teva Investigational Site 332

Seoul, , South Korea

Teva Investigational Site 333

Seoul, , South Korea

Countries

United States; Australia; Belarus; Brazil; Canada; Israel; Mexico; New Zealand; Poland; Russia; Singapore; South Korea

References

Fraser C, Brown P, Megason G, Ahn HS, Cho B, Kirov I, Frankel L, Aplenc R, Bensen-Kennedy D, Munteanu M, Weaver J, Harker-Murray P. Open-label bendamustine monotherapy for pediatric patients with relapsed or refractory acute leukemia: efficacy and tolerability. J Pediatr Hematol Oncol. 2014 May;36(4):e212-8. doi: 10.1097/MPH.0000000000000021.

Reference Type: BACKGROUND

PMID: 24072240 (View on PubMed)

Other Identifiers

2010-020768-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C18083/2046

Identifier Type: -

Identifier Source: org_study_id