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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Stanford University

  lead OTHER

Principal Investigators

• Wen-Kai Weng · Stanford University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2010-05-31

Completion

2010-05-31

FDA Drug

Yes

Countries

• United States

Study Locations