Burkitt Lymphoma Clinical Trial
Official title:
Multicentre Study to Optimize Therapy of Burkitt's Leukemia (B-ALL) and Non-Hodgkin Lymphoma
The study was set up to assess the efficacy and tolerability of a chemotherapy-immunotherapy
combination programme originally introduced by GMALL (the German cooperative group for adult
acute lymphoblastic leukemia)in 2002, to improve remission rate, overall and disease-free
survival rates of adult patients with Burkitt's leukemia and lymphoma.
The therapy includes a maximum of six chemotherapy courses (two with high doses of
methotrexate and cytarabine) plus anti-CD20 antibody (Rituximab, up to 8 total doses),
supplemented by local radiation therapy in the case of initial mediastinal or central
nervous system (CNS) involvement or a residual tumor after chemotherapy.
Cycle A1: prednisone-cyclophosphamide pre-phase (5 days), Rituximab on day 0, chemotherapy
on days 1-5 (dexamethasone, iphosphamide, vincristine, high-dose methotrexate, triple
intrathecal therapy).
Cycle B1: Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vincristine,
cyclophosphamide, high-dose methotrexate, adriamycin, triple intrathecal therapy) Cycle C1:
Rituximab on day 0, chemotherapy on days 1-5 (dexamethasone, vindesine, high-dose
methotrexate, etoposide, high-dose cytarabine).
Cycle A2: like cycle A1, without pre-phase. Cycle B2: like cycle B1. Cycle C2: like cycle
C1. Cycle C2 is followed by two additional Rituximab injections.
Notes:
1. patients with stage I-II disease without mediastinal tumor or extranodal involvement
receive only the first 4 cycles (A1 to A2).
2. patients aged >55 years do not receive cycles C (sequence: A1, B1, A2, B2, A3, B3 or
A1, B1, A2, B2 if limited stage, with reduced-dose methotrexate).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01943682 -
Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma
|
Phase 1 | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Recruiting |
NCT05020392 -
Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma
|
Phase 3 | |
| Recruiting |
NCT04545762 -
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
|
Phase 1 | |
| Terminated |
NCT03864419 -
Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda
|
Phase 1 | |
| Terminated |
NCT02700022 -
A Phase I Study of Alisertib + R-EPOCH for Treatment of Myc-Positive Aggressive B-cell Lymphomas
|
Phase 1 | |
| Completed |
NCT00849147 -
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
|
Phase 2 | |
| Completed |
NCT00822432 -
Coproporphyrine Isomers and Methotrexate Elimination
|
N/A | |
| Recruiting |
NCT00180882 -
LMBA02 Protocol for Patients With a Burkitt Lymphoma
|
Phase 3 | |
| Recruiting |
NCT06060782 -
Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
|
Phase 1 | |
| Active, not recruiting |
NCT02996773 -
Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine
|
Phase 1 | |
| Recruiting |
NCT05565417 -
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03298828 -
CD19 CAR and PD-1 Knockout Engineered T Cells for CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT00719888 -
Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease
|
Phase 2 | |
| Recruiting |
NCT06131801 -
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
|
||
| Recruiting |
NCT04425421 -
Recommendations for the Treatment of Children With Burkitt's Lymphoma
|
||
| Active, not recruiting |
NCT00001337 -
Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05518383 -
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
|
Phase 4 | |
| Terminated |
NCT01028716 -
Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Recruiting |
NCT05794880 -
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing
|
N/A |