Lymphoma Clinical Trial
Official title:
An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in
treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed
advanced aggressive non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, open-label, uncontrolled, multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BI 2536 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity during the first treatment course. Up to 24 patients are
treated at the MTD.
After completion of study treatment, patients are followed periodically until disease
progression or initiation of another cancer treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
| Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
| Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
| Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
| Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
| Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
| Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
| Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |