Combination Chemotherapy in Treating Young Patients with Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 07-001427
NCT ID: NCT00408005
Sponsor Protocol Number: AALL0434
About this study
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- T-Acute Lymphocytic Leukemia patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434
- Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV
- B-lineage lymphoblastic lymphoma will not be eligible for this study
- 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)
- express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a
- if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (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
- T-NHL patients with tissue available for flow cytometry, the criteria for diagnosis should be analogous to T-ALL
- for tissue processed by other means (i.e. paraffin blocks), the method and criteria to establish the diagnosis of T-NHL defined by the submitting institution will be accepted
- Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine
- IT chemotherapy with cytarabine is allowed prior to registration for patient convenience
- this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture
- CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
- systemic chemotherapy must begin within 72 hours of this IT therapy
- Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy
- they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC)
- steroid pretreatment may alter the risk group assessment
- if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients CANNOT be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above
- patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented
- For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study
- Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine
- Patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined by the treating physician or a neurologist, are not eligible to receive nelarabine
- these restrictions in eligibility are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients
- for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years
- Pregnant or lactating females are ineligible
- Patients with Down syndrome are ineligible to enroll onto this study
- For T-NHL patients the following additional exclusion criteria apply
- B-precursor lymphoblastic lymphoma
- Morphologically unclassifiable lymphoma
- Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
- CNS3-positive or testicular involvement
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Vilmarie Rodriguez, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office