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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00481832
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    4 gm /m² IV over 2 hours on day 8
  • BCNU — DRUG
    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)
  • Etoposide — DRUG
    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.
  • Filgrastim — DRUG
    10µg/kg sc qd starting day following cyclosphamide (or VP-16) until last day of apheresis
  • Antithymocyte globulin — DRUG
    1.5 mg/kg/d, IV from day -11 to -7
  • Cyclosporine — DRUG
    5mg/kgbid,variable, po or IV
  • Mycophenolate mofetil — DRUG
    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.
  • Rituximab — DRUG
    375 mg/m2 IV (calculated based on actual body weight) on day 1 and day 7. Administered per current standard of care..
  • Autologous hematopoietic stem cell transplantation (auto-HSCT) — PROCEDURE
    Auto-HCT involves an intravenous infusion of a participant's previously collected and frozen white blood cells collected after treatment with mobilizing agents
  • Allogeneic hematopoietic stem cell transplantation (allo-HSCT) — PROCEDURE
    Allo-HCT involves an intravenous infusion of a donor's white blood cells collected after treatment with mobilization with filgrastim (G-CSF)
  • Total lymphoid irradiation — PROCEDURE
    TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
  • CD34+ Cells — DRUG
    2 x 10e6 CD34+ cells per kg actual body weight on Day 0
  • Solu-Medrol — DRUG
    1 mg/kg, Day-11 to Day-7

Study Details

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.

Key Dates

Start date
Jan 31, 2007
Status verified
Jan 2018
Primary completion
Oct 27, 2014
Completion
Mar 30, 2017

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: T & B Cell Mobilization Auto & Allo HCT
    A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.

Primary Outcome Measure

Event-free Survival (EFS) [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CA

Related Studies