Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell

Status Recruiting

Clinical Trial Summary

Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation.

Clinical Trial Description

Conditioning therapy - Busulfan (Busulfex®; Patheon Manufacturing Services LLC, Greenville, NC 27834) 3.2 mg/kg + 5% DW (the diluent quantity should be 10 times the volume of Busulfan, so that the final concentration of busulfan becomes approximately 0.5 mg/mL), intravenously for 3 hours once daily for 3 days (days -7 to -5) - Fludarabine (Fludarabine®, Zydus Hospira Oncology Private Ltd., Ahmedabad, India) 30 mg/m2 + 5% DW 100㎖, intravenously for over 1 hour once daily for 6 days (days -8 to -3) - Busulfan should be infused as soon as completion of fludarabine infusion Primary objective of this study I. To determine the 2-year progression-free survival of this reduced toxicity conditioning in relapsed or refractory T- and NK/T-cell non-hodgkin lymphoma patients. Secondary endpoints I. To evaluate the response rate, engraftment rate and time to engraftment, 2-year overall survival, 100-days treatment-related mortality, regimen-related toxicities by CTCAE version 4.03, post-transplantation complications (HVOD, acute/chronic graft-versus-host disease (GVHD), cytomegalovirus (CMV) infection,CMV disease) of this reduced toxicity conditioning in relapsed or refractory T- and NK/T-cell non-hodgkin lymphoma patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02859402
Study type	Interventional
Source	Keimyung University Dongsan Medical Center
Contact	Young Rok Do, MD., Ph.D.
Phone	+82-10-3541-1160
Email	dyr1160@dsmc.or.kr
Status	Recruiting
Phase	Phase 2
Start date	December 2016
Completion date	December 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00992446` - Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma	Phase 2
Recruiting	`NCT04774068` - Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas	Phase 1
Completed	`NCT03263637` - Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies	Phase 1
Recruiting	`NCT05377827` - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies	Phase 1
Active, not recruiting	`NCT01919619` - Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies	Phase 2
Active, not recruiting	`NCT03061188` - Nivolumab and Veliparib in Treating Patients With Recurrent or Refractory Stage IV Solid Tumors That Cannot Be Removed by Surgery or Lymphoma With or Without Alterations in DNA Repair Genes	Phase 1
Completed	`NCT03833180` - A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)	Phase 1
Terminated	`NCT03195010` - Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia	Phase 2
Completed	`NCT00723099` - Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer	Phase 2
Completed	`NCT02424968` - CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma	Phase 2
Terminated	`NCT01746173` - CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma	Phase 2
Recruiting	`NCT05127135` - Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies	Phase 1
Completed	`NCT00880815` - Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant	Phase 1
Active, not recruiting	`NCT03333486` - Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer	Phase 2
Recruiting	`NCT04594135` - Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies	Phase 1
Recruiting	`NCT04934774` - Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas — RRTCLAlloSCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms