Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Bortezomib
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Doxorubicin Hydrochloride
- drug: Etoposide
- drug: Hydrocortisone Sodium Succinate
- drug: Ifosfamide
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Pegaspargase
- radiation: Radiation Therapy
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Bortezomib
- drug: Cyclophosphamide
- drug: Cytarabine
- drug: Daunorubicin Hydrochloride
- drug: Dexamethasone
- drug: Doxorubicin Hydrochloride
- drug: Etoposide
- drug: Hydrocortisone Sodium Succinate
- drug: Ifosfamide
- drug: Leucovorin Calcium
- drug: Mercaptopurine
- drug: Methotrexate
- drug: Pegaspargase
- radiation: Radiation Therapy
- drug: Thioguanine
- drug: Vincristine Sulfate
- drug: Daunorubicin
- drug: Doxorubicin
- drug: Vincristine
Eligibility
Inclusion Criteria:
- T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if
open for the classification of ALL patients) prior to treatment and enrollment on
AALL1231
- All patients must be > 1 and < 31 years of age
- Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic
lymphoma (T-LLy) stages II-IV
- Note: a diagnosis of T-ALL is established when leukemic blasts lack
myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation
[CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more
of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in
peripheral blood or > 25% in the bone marrow; if surface CD3 is expressed on all
leukemic cells, additional markers of immaturity, including terminal
deoxynucleotidyl transferase (TdT), CD34 or CD99 will be assessed for expression;
cases with uncertain expression will receive additional review within the
appropriate Children's Oncology Group (COG) reference laboratory
- For T-LLy patients with tissue available for flow cytometry, the criterion for
diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e.
paraffin blocks), the methodology and criteria for immunophenotypic analysis to
establish the diagnosis of T-LLy defined by the submitting institution will be
accepted
- All patients and/or their parents or legal guardians must sign a written informed
consent; assent, when appropriate, will be obtained according to institutional
guidelines
Exclusion Criteria:
- Patients must not have received any cytotoxic chemotherapy for either the current
diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of
protocol therapy on AALL1231, with the exception of:
- Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days)
in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14
days) in the 28 days prior to initiating induction chemotherapy; prior exposure
to ANY steroids that occurred > 28 days before the initiation of protocol therapy
does not affect eligibility; the dose of prednisone or methylprednisolone does
not affect eligibility
- Intrathecal cytarabine (the CNS status must be determined based on a sample
obtained prior to administration of any systemic or intrathecal chemotherapy,
except for steroid pretreatment) system chemotherapy must begin with 72 hours of
this IT therapy; or
- Pretreatment with hydroxyurea; or
- 600 cGy of chest irradiation, if medically necessary
- Pre-treatment with dexamethasone in the 28 days prior to initiation of
protocol therapy is not allowed with the exception of a single dose of
dexamethasone use during sedation to prevent or treat airway edema;
inhalation steroids and topical steroids are not considered pretreatment
- Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
- Uncontrolled seizure disorder
- Diagnosis of Down syndrome (Trisomy 21)
- Patients who are pregnant since fetal toxicities and teratogenic effects have been
noted for several of the study drugs; a pregnancy test is required for female patients
of childbearing potential
- Lactating females who plan to breastfeed
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation
- Patient has hypersensitivity to bortezomib, boron, or mannitol
- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study
- Participation in clinical trials with other investigational agents not included in
this trial, within 14 days of the start of this trial and within 30 days of any dose
of bortezomib
Ages Eligible for Study
1 Year - 30 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.
