Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440726
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : July 3, 2012
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium

February 23, 2007
February 27, 2007
July 3, 2012
June 2006
February 2011   (Final data collection date for primary outcome measure)
  • Dose limiting toxicity [ Time Frame: Each dose level is evaluated ]
  • Maximum tolerated dose [ Time Frame: Each dose level is evaluated ]
  • Rate of remission [ Time Frame: The rate of remission will be evaluated upon completion of the phase I portion and then the phase II portion. ]
  • Dose limiting toxicity
  • Maximum tolerated dose
  • Rate of remission
Complete list of historical versions of study NCT00440726 on Archive Site
Not Provided
Disease free survival
Not Provided
Not Provided
Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia

This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.

The Phase I portion of this study is complete and the dose for the phase II portion of the study is 1.3mg/m2/day. The phase II portion of the study is open and accruing.

All patients will receive 1 course of chemotherapy unless medical complications prevent the administration of some of the drugs. Treatment will last about 1 month.

Treatment on this study will consist of a combination of 7 anti-cancer medications. The 7 anti-cancer medicines are bortezomib, vincristine, dexamethasone, PEG-asparaginase, doxorubicin, cytarabine (Ara-C), and methotrexate (MTX).

If you are in the Phase I portion of this study, you will be given an assigned dose of bortezomib. The dose of bortezomib will be based on doses given in previous studies done with adults and children. At each dose level of bortezomib, between 3 and 6 children will receive bortezomib in combination with chemotherapy. If the side effects are not too severe, the next group of children will receive a higher dose. The dose will continue to be increased until we find the dose that causes serious side effects. Your dose of bortezomib will not be increased. If you have bad side effects, your dose may be decreased.

The dose used during the Phase 2 part of this study will be determined by the outcome of the Phase I study. The highest dose used in Phase I that was tolerated without serious side effects will be the one used in Phase 2.

Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • Drug: bortezomib (Velcade)
    Intravenous at 1.3mg/m2 on days 1, 4, 8 and 11
    Other Name: Velcade
  • Drug: dexamethasone
    Intravenous or oral administration for 14 days.
  • Drug: PEG-asparaginase
    Intramuscular injection
  • Drug: doxorubicin
    Intravenous infusion
  • Drug: cytarabine
    Intrathecal administration on day 1
  • Drug: methotrexate
    Intrathecal administration
  • Drug: vincristine
    Intravenous push on days 1, 8, 15, 22
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
February 2011   (Final data collection date for primary outcome measure)

This is an abbreviated list.

Inclusion Criteria:

  • Patients must be greater than 1 year and less than 21 years of age to participate in this study.
  • Patients must have relapsed acute lymphoblastic leukemia (ALL) with or without evidence of central nervous system (CNS) disease.
  • Patients must have adequate kidney, heart, and liver function.

Exclusion Criteria:

  • Patients who are pregnant or breast feeding.
  • Patients who have an allergy to asparaginase products
  • Patients who have an active uncontrolled infection.
  • Patients who have numbness or tingling in the hands or feet or constipation.
Sexes Eligible for Study: All
1 Year to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Korea, Republic of
Not Provided
Not Provided
Therapeutic Advances in Childhood Leukemia Consortium
Therapeutic Advances in Childhood Leukemia Consortium
Not Provided
Study Chair: Yoav Messinger, MD Children's Hospital and Clinics of Minnesota
Therapeutic Advances in Childhood Leukemia Consortium
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP