Combination chemotherapy with/without targeted therapy to treat younger patients with newly diagnosed leukemia and lymphoma

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"Does adding targeted chemotherapy improve effectiveness of standard combination chemotherapy in treating younger patients?"
Age:
1 to 30 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
leukemia, Non-Hodgkin's lymphoma, cancer, chemotherapy
Type:
Drug study, Phase 3
Investigator:
Description
This study compares how well combination chemotherapy works when given with or without bortezomib (targeted chemotherapy) 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 standard combination chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard combination chemotherapy with or without bortezomib is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
This study requires
Please contact for details
Who can participate?
Inclusion Criteria:

- T-ALL: T-ALL patients must be enrolled on Project Every Child (APEC14B1) prior to treatment and enrollment on AALL1231

- T-LLy: if Project: Every Child (APEC14B1) is available, T-LLy patients must be enrolled on APEC14B1 prior to treatment and enrollment on AALL1231

- 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

- 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

- Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity

- Uncontrolled seizure disorder

- Diagnosis of Down syndrome (Trisomy 21)

- Patients who are pregnant; 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
Resources
Schedule
Study duration and period
Treatment: 2.5-3 years Follow-up: 10 years
Recruitment period
From Oct. 10, 2014
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Wendy Lashway
Research Topic
Conditions:
  • Adult T Acute Lymphoblastic Leukemia
  • Childhood T Acute Lymphoblastic Leukemia
  • Stage II Childhood Lymphoblastic Lymphoma
  • Stage II Contiguous Adult Lymphoblastic Lymphoma
  • Stage II Non-Contiguous Adult Lymphoblastic Lymphoma
  • Stage III Adult Lymphoblastic Lymphoma
  • Stage III Childhood Lymphoblastic Lymphoma
  • Stage IV Adult Lymphoblastic Lymphoma
  • Stage IV Childhood Lymphoblastic Lymphoma
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia

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