Evaluating multiple chemotherapy combinations in treating younger patients with newly diagnosed leukemia or lymphoma

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"Can giving different combinations of chemotherapy, in different doses, kill more cancer cells in younger leukemia/lymphoma patients?"
Age:
1 to 30 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
leukemia, cancer, chemotherapy
Type:
Drug study, Phase 3
Investigator:
Description
This study looks at different combinations of chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed leukemia or lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
This study requires
Please contact for details
Who can participate?
Inclusion Criteria:

- B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0932

- Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932

- B-ALL patients must have an initial white blood cell count < 50,000/uL

- Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible

- Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted

- All patients and/or their parents or legal guardians must sign a written informed consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met


Exclusion Criteria:

- With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932

- Patients receiving prior steroid therapy may be eligible for AALL0932

- Patients with central nervous system 3 (CNS3) leukemia

- CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy

- B-ALL patients with testicular leukemia are not eligible for AALL0932

- For B-LLy patients the following additional exclusion criteria apply:

- T-lymphoblastic lymphoma

- Morphologically unclassifiable lymphoma

- Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma

- CNS3-positive disease or testicular involvement

- M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their infants

- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Resources
Schedule
Study duration and period
Please contact for details
Recruitment period
From April 22, 2011
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Wendy Lashway
Research Topic
Conditions:
  • Adult B Lymphoblastic Lymphoma
  • Childhood B Acute Lymphoblastic Leukemia
  • Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
  • Childhood B Lymphoblastic Lymphoma
  • Down Syndrome
  • Stage I B Lymphoblastic Lymphoma
  • Stage II B Lymphoblastic Lymphoma
  • Untreated Adult Acute Lymphoblastic Leukemia
  • Untreated Childhood Acute Lymphoblastic Leukemia

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