Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma

Summary

The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

DRUG

Cyclophosphamide

4 gm /m² IV over 2 hours on day 8

DRUG

BCNU

The dose of BCNU will be based on actual body weight unless the actual body weight is more than 15 kg greater than the ideal body weight in which case the adjusted ideal body weight will be used: 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

60mg/kg, IV over 4 hours on day -4 pre-transplant and for preparative regimen. The dose of etoposide for mobilization is 2 gm/ m².

DRUG

Filgrastim

10µg/kg sc qd starting day following cyclosphamide (or VP-16) until last day of apheresis

DRUG

Antithymocyte globulin

1.5 mg/kg/d, IV from day -11 to -7

DRUG

Cyclosporine

5mg/kgbid,variable, po or IV

DRUG

Mycophenolate mofetil

15 mg/kg po on day 0, at 5-10 hours after mobilized PBPC infusion is complete. Thereafter, beginning 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. Doses will be rounded up to the nearest 250 mg (capsules are 250 mg). MMF will be stopped on day +28 for matched related donors. For one antigen mismatched related or unrelated donors, the taper will begin on day +40. MMF will be tapered by 10% weekly till off, typically by day +96. If there is nausea and vomiting at any time preventing the oral administration of MMF, MMF should be administered intravenously at an equal dose. MMF dosing is based on actual body weight.

DRUG

Rituximab

375 mg/m2 IV (calculated based on actual body weight) on day 1 and day 7. Administered per current standard of care..

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 is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT

DRUG

CD34+ Cells

2 x 10e6 CD34+ cells per kg actual body weight on Day 0

DRUG

Solu-Medrol

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

2007-01-31

Primary Completion

2014-10-27

Completion

2017-03-30

Countries

• United States

Study Locations