NCT00482053

Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT

A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.

Detailed description

This study tests a tandem transplant approach that starts with transplantation of the participant's own hematopoietic (blood) cells, eg, autologous hematopoietic cell transplant (auto-HCT) as preparation for an subsequent matched-donor allogeneic HCT (allo-HCT). Participants will be have progenitor cells (stem cells) mobilized into the peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim (G-CSF); undergo apheresis to collect autologous peripheral blood stem cells (PBSC, aka hematopoietic cells); and be re-infused with ≥ 3 x 10e6 CD34+ cells/kg (auto-HCT). Subsequently, participants will receive therapeutic, non-myeloablative chemotherapy (carmustine + cyclophosphamide + etoposide), then transplant conditioning \[total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)\] followed by ≥ 2 x 10e6 CD34+ cells/kg allogeneic PBSC obtained from a human leukocyte antigen (HLA)-matched or HLA single allele / antigen-mismatched donor (allo-HCT). Donors will be mobilized with 16 µg/kg filgrastim. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT infusion treatment includes cyclosporine and mycophenolate mofetil (MMF) Subject's participation ends if a suitable matched donor is not identified within the 150 days. Pre-medication treatments administered during this study may include acetaminophen; diphenhydramine; hydrocortisone; and methylprednisolone.

Conditions

• Lymphoma, B-cell
• Lymphoma, Non-Hodgkin
• Diffuse Large B-cell Lymphoma (DLBCL)
• Malignant Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
PROCEDURE	Autologous hematopoietic stem cell transplantation (auto-HSCT)	Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
PROCEDURE	Allogeneic hematopoietic stem cell transplantation (allo-HSCT)	Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
PROCEDURE	Total lymphoid irradiation (TLI)	TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
DRUG	Rituximab	375 mg/m2 IV days 1 and 7 over 4 to 8 hours
DRUG	Carmustine	Based on body weight, unless its more than 15 kg greater than the idal body 15mg/kg (max dose 550 mg/m2) day -6 over 2 hours. Males IBW = 50 kg + 2.3 kg/inch over 5 feet Females IBW = 45.5 kg + 2.3 kg/inch over 5 feet Adjusted IBW = IBW + 50% (actual weight - IBW)
DRUG	Etoposide	60 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization)
DRUG	Filgrastim	10 µg/kg/day subcutaneous starting Day 9 until last day of apheresis. 5 ug/kg actual body weight per day will be started at Day +6 after allo-HCT until hematologic recovery
DRUG	Anti-thymocyte globulin (ATG)	1.5 mg/kg/day for 5 days
DRUG	Cyclosporine	5.0 mg/kg twice daily from day -3 until after day +56
DRUG	Mycophenolate mofetil (MMF)	250 mg (total) twice daily, oral 15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. On day +1 MMF is taken at 15 mg/kg po b.i.d. (30 mg/kg/day) if transplantation was using a matched related donor and 15 mg/kg po t.i.d if from a matched unrelated donor or a one antigen mismatched donor.
DRUG	Cyclophosphamide	100 mg/kg will be administered over 2 hours on day -2
DRUG	Acetaminophen	Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion
DRUG	Diphenhydramine	Pre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion
DRUG	Hydrocortisone	Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion
DRUG	Methylprednisolone	Anti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-06-04
• Last updated: 2018-05-14
• Results posted: 2018-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study