Trial Search Results

Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This phase II trial studies how well giving bortezomib together with combination chemotherapy works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Drug: bortezomib
  • Drug: doxorubicin hydrochloride
  • Drug: pegaspargase
  • Drug: vincristine sulfate
  • Drug: dexamethasone
  • Drug: cytarabine
  • Drug: methotrexate


Phase 2


Inclusion Criteria:

   - Voluntary written informed consent before performance of any study-related procedure
   not part of normal medical care, with the understanding that consent may be withdrawn
   by the subject at any time without prejudice to future medical care

   - Female subjects who:

      - Are postmenopausal for at least 1 year before the screening visit, OR

      - Are surgically sterile, OR

      - If they are of childbearing potential, agree to practice 2 effective methods of
      contraception, at the same time, from the time of signing the informed consent
      form through 30 days after the last dose of bortezomib, or agree to completely
      abstain from heterosexual intercourse

   - Male subjects, even if surgically sterilized (i.e., status post vasectomy) who:

      - Agree to practice effective barrier contraception during the entire study
      treatment period and through a minimum of 30 days after the last dose of study
      drug, OR

      - Agree to completely abstain from heterosexual intercourse

   - • The patient has relapsed or refractory B or T cell acute lymphoblastic leukemia that
   has progressed following at least one prior therapy. Ph+ patients are eligible.
   Relapsed ALL is defined in patients as the reappearance of leukemia cells in the
   peripheral blood or bone marrow or appearance of extramedullary disease after a
   complete remission. Refractory ALL is defined in patients as failure to achieve a
   complete remission after induction therapy. Complete remission is defined by <5%
   leukemia cells in the bone marrow with recovery of peripheral blood counts. Relapsed
   disease can be documented by bone marrow biopsy (>5% cells in the bone marrow) or by
   flow cytometry in the peripheral blood or biopsy of extramedullary disease.

   - Must have received at least one (1) line of prior systemic therapy that may NOT have
   included VELCADE (bortezomib); patients who have undergone autologous/allogeneic stem
   cell transplantation are eligible

   - Transplant eligible patients are eligible

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

   - No poorly controlled intercurrent illness including, but not limited to, ongoing or
   active infection, poorly controlled diabetes, symptomatic congestive heart failure, or
   psychiatric illness that in the opinion of the investigator would limit compliance
   with study requirements

   - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper
   limit of normal

   - Total bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is deemed due to
   leukemia infiltration. In these patients, dose modifications may be required based on
   standard guidelines.

   - Patients must have adequate renal function defined as creatinine clearance of >= 30
   ml/minute (Cockcroft-Gault)

Exclusion Criteria:

   - Patient has > 1.5 x ULN total bilirubin

   - Patient has >= grade 2 peripheral neuropathy

   - Patient had myocardial infarction within 6 months prior to enrollment or has New York
   Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe
   uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
   ischemia or active conduction system abnormalities; prior to study entry, any
   electrocardiogram (ECG) abnormality at screening must be documented by the
   investigator as not medically relevant

   - Patient has hypersensitivity to bortezomib, boron, or mannitol

   - Female subject is pregnant or lactating

   - Serious medical or psychiatric illness likely to interfere with participation in this
   clinical study

   - Diagnosed or treated for another malignancy within 2 years of enrollment, with the
   exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
   the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy

   - Participation in clinical trials with other investigational agents not included in
   this trial throughout the duration of this trial

   - Radiation therapy within 3 weeks before randomization; enrollment of subjects who
   require concurrent radiotherapy (which must be localized in its field size) should be
   deferred until the radiotherapy is completed and 3 weeks have elapsed since the last
   date of therapy

   - The patient has been exposed to >= 350mg/m^2 of anthracycline (doxorubicin equivalent)

   - The patient has a left ventricular ejection fraction of < 40%

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Uzma Ahmed