Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Phase 1-2 Study of 6-Thioguanine in Combination With Methotrexate and 6-Mercaptopurine During Maintenance Therapy of Childhood Non-Hodgkin's Lymphoma
The purpose of this phase 1-2 study is to explore the applicability of supplementing
standard methotrexate/6-mercaptopurine (MTX/6MP) maintenance therapy of children with
non-Hodgkin lymphoma with 6-thioguanine (6TG).
The investigators hypothesize that addition of 6TG to 6MP-based maintenance therapy of
patients with high TPMT activity will mimic the more favourable thiopurine metabolism of
patients with low TPMT activity and ultimately reduce relapse rates.
MTX/6MP maintenance therapy is challenged by treatment related liver toxicity, failure to achieve the target treatment parameter in all patients, and lack of direct parameters for monitoring treatment efficacy or even intensity. Patients with low activity of thiopurine methyltransferase (TPMT), an enzyme involved in the metabolism of 6MP, have lower levels of liver toxic metabolites (MeMPs), higher levels of the major active metabolites (TGNs), and reduced relapse rates. Most patients (90%) have high TPMT activity. Nearly all patients with high TPMT activity and high MeMP levels experience elevated liver enzymes. Increasing the 6MP dose in patients with high TPMT activity, to intensify therapy, will mainly lead to further increase in the MeMP level. A novel approach compensating the adverse thiopurine metabolism of the majority of patients is warranted. ;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
| Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
| Recruiting |
NCT06018129 -
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
| Completed |
NCT01939327 -
Safety and Efficacy of Revlimid® (Lenalidomide) With Mabthera® (Rituximab) in Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Completed |
NCT00503451 -
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00509379 -
Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma
|
Phase 2 | |
| Terminated |
NCT00383097 -
Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT01010295 -
A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae
|
Phase 2 | |
| Completed |
NCT00992446 -
Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05066958 -
Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05205512 -
Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial
|
N/A | |
| Recruiting |
NCT05006716 -
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03297424 -
A Study of PLX2853 in Advanced Malignancies.
|
Phase 1 | |
| Completed |
NCT02767388 -
Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery
|
||
| Active, not recruiting |
NCT03997968 -
A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors
|
Phase 1/Phase 2 |