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All patients with newly diagnosed acute lymphoblastic leukemia, with a risk classification system that can be used to assign medication to Children's Oncology Group frontline ALL research findings. To obtain classification data for correlative studies relating to the new COG ALL treatment regimens. Patients are enrolled in and out with blood sample and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping, deoxyribonucleic acid ploidy, genomic variation, and cytogenetic analysis by flow cytometry and fluorescent in situ hybridization for ALL confirmation and classification, as well as post-induction therapy for immunophenotyping.
Source link: https://clinicaltrials.gov/ct2/show/NCT01142427
Patients at a high risk patients will be given a reintensification phase prior to transplant in first remission. The participant's blood counts have recovered from Remission Induction's blood tests, and it will go into consolidation mode. RE-INDUCTION: This phase aims to expand the participant's overall response to therapy by attempting to recover his/her leukemia. Following Re-Induction, participants with ITMHA, mitoxantrone, peg-asparaginase, dexamethasone, bortezomib, and vorinostat can proceed directly to stem cell transplant if stem cell transplant, according to stem cell transplant. Participants who are MRD positive following Consolidation or Reinduction may be able to obtain Chimeric Antigen Receptor T-Cell therapy, if available, or proceed to a Reinforcement phase before proceeding to stem cell transplant. Participants with poor MRD after consolidation will miss the re-intensification phase and instead receive maintenance to prevent the leukemia from returning.
Source link: https://clinicaltrials.gov/ct2/show/NCT02553460
The results of administering 1 to 2 cycles of blinatumomab as bridging therapy in children, adolescent, and young adults with relapse or persistent MRD B-ALL will be determined by this Phase 2 research. Subjects who have flow cytometry negative MRD after a single cycle of blinatumomab can proceed directly to HCT, while those who are not MRD positive by flow cytometry may face a second cycle of blinatumomab. After a 2nd cycle of blinatumomab, a MRD positive by flow cytometry will come off the study.
Source link: https://clinicaltrials.gov/ct2/show/NCT04556084
Determine the course of financial uncertainty as time progresses, as reported by parents of children and adolescents with acute lymphoblastic leukemia ages 1 to 11. 9 years from the start to completion of ALL therapy. Identifying factors related with financial distress among families of children and adolescents aged 1 to 14. 9 years with newly diagnosed ALL. Parents complete surveys over 15-30 minutes at the start of their child's induction chemotherapy, at the start of maintenance chemotherapy, and at the end of last chemotherapy. Parents can also participate in a one-time individual interview lasting over 30-45 minutes.
Source link: https://clinicaltrials.gov/ct2/show/NCT04928599
Blocked-negative B cell precursor acute lymphoblastic leukemia patients with minimal residual disease in combination with chemotherapy are more likely to die in combination with chemotherapy alone after induction and intensification chemotherapy, according to a multiparameter flow cytometric evaluation of residual blasts. After introduction and intensification chemotherapy, we'll compare the relapse-free survival of blinatumomab in association with chemotherapy to chemotherapy alone in MRD-negative patients. Compare the OS and RFS of those patients who are MRD positive at step 3 randomization/registration and then convert to MRD negative after 2 cycles of blinatumomab or consolidation chemotherapy. To determine differences in MRD kinetics among patients with BCR/ABL1-like B-lineage ALL, and to compare the OS of patients with BCR-ABL-like phenotypes with those without BCR-ABL-like phenotypes. INTENSIFICATION THERAPY: Patients receive intensification therapy, consisting of high-dose methotrexate IV over 2 hours on day 1, and 8, as well as pegaspargase IM or IV on day 9. Patients who were randomized to the blinatumomab group receive blinatumomab IV daily on days 1-28. Patients with CD20 positive blood pressure can be given rituximab beginning 4 weeks from day 1 of cycle 1, etoposide, methotrexate, and CD20 positive patients can be eligible for rituximab. Patients with CD20+ patients will optionally receive cytarabine, etoposide, methotrexate, and methotrexate beginning 8 weeks on cycle 3 and upwards. Patients are randomized to blinatumomab repeat cycle 4 and then receive blinatumomab IV every day on days 1-28.
Source link: https://clinicaltrials.gov/ct2/show/NCT02003222
With ALL, we will determine if there are any adolescent and young adult acute lymphoblastic leukemia patients with a documented treatment strategy that is in accordance with NCCN guidelines on AYAs. To determine the percentage of AYA ALL patients receiving medical attention during induction and post-induction therapy that meets NCCN recommendations for AYAs with ALL. When stratified by age group, it is estimated that the effect of treating physician specialties and facility type has increased the chances of AYA ALL patients receiving a documented treatment plan congruent with NCCN guidelines. When stratified by age group, to determine the effect of treating physician specialties and facility type on the likelihood of AYA ALL patients receiving induction and post-induction therapy concordant with NCCN guidelines. For every patient, induction and post-induction care, NCCN guidelines are either conscient with NCCN guidelines or non-conservant with NCCN recommendations.
Source link: https://clinicaltrials.gov/ct2/show/NCT03204916
Patients with relapsed or refractory adult T-acute lymphoblastic lymphoma and the related disease T-lymphoblastic lymphoma are seriously affected by the results, with 30% of the patients responding to first salvage therapy and a long-term survival of only 10%. In an animal model, recent results reveal clear evidence that CXCR4 signaling plays a significant role in T-cell leukemia cell maintenance and leukemia initiating activity, and that targeting CXCR4 signaling in T-cell leukemia cell repair and leukemia initiating activity.
Source link: https://clinicaltrials.gov/ct2/show/NCT02763384
Minimal residual disease detection in the bone marrow is highly predictive of disease relapse in patients with acute lymphoblastic leukemia patients and is based on a single bone marrow aspirate sample. The current standard of care assessment of disease in the central nervous system is based on cerebrospinal fluid testing and analysis for blasts that have cytology only, which does not indicate occult amounts of CNS disease. We have found cases where there is a difference between cytopathology and flow cytometry results in an analysis of patients with ALL POB treatment protocols. Only patients with ALL or LBL have standard of care or on study will be included in reports where Dr. Nirali Shah is or has served as the PI will be found.
Source link: https://clinicaltrials.gov/ct2/show/NCT03627208
In children with relapsed or refractory B acute lymphoblastic leukemia, hettuzumab ozogamicin treatment in one cycle of inotuzumab ozogamicin therapy in children with relapsed or refractory CD22+ B acute lymphoblastic leukemia, it was determined by morphologic response rate. To determine the safety of single agent inotuzumab ozogamicin administered at the adult recommended phase 2 dose to pediatric patients with relapsed or refractory CD22+ B-ALL. After radiation therapy with inotuzumab ozogamicin, we'll examine the relationship between leukemic blast CD22 surface expression and site density, as well as the relationship with cytogenetics and clinical outcomes. To investigate the effects of inotuzumab ozogamicin on humoral immune function and peripheral B cell populations. To describe the degree of MRD by next-generation high-throughput sequencing methods that may be able to identify low-level leukemic blast populations that have altered CD22 expression. To discuss the interaction between inotuzumab ozogamicin and chimeric antigen receptor T cell therapy before or after therapy with inotuzumab ozogamicin. Patients on days 1, 8, 21, and 36 of cycle 2 for CNS1 patients, patients receive methotrexate intrathecally on days 1, 8, 9, 15, and 36 of cycle 2 for CNS 2 patients, day 1, 8, 15, 22, and 36 of cycle 2 for CNS 2 patients. On days 1, 8, 9, 22, and 36 of cycle 2 for CNS 2 patients, day 1, 8 and 36 of cycle 2 for CNS 1 patients, patients receive methotrexate intrathecally on days 1, 8, 15, 16, 8, 15, 16, 8, 15, 8, 15, 22, and 36 of cycle 2 for CNS 2 patients, and 36 of cycle 2 patients, thecy intrathecy intrathecy, ta, cycle 1 and 36 of cycle 2 patients, cycle 2 for CNS 2 patients, and 36 of cycle 2 patients, t, and 36 of cycle 2 patients, and 36 of cycle 2 patients, and 36 of cycle 2 patients, cycle 2 patients, 8. On days 1, 8, 22, 21, and 36 of cycle 1 and Day 8 and 36 of cycle 2, CNS 3 patients receive methotrexate intrathecal triple therapy IT. If excess toxicity is seen at dose level 1, inotuzumab ozogamicin dosing will be reduced for dose level -1.
Source link: https://clinicaltrials.gov/ct2/show/NCT02981628
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