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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00482053
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

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

Interventions

  • 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 (TLI) — PROCEDURE
    TLI is administered in 80cGy fractions on Days -11 to Day-7 relative to allo-HSCT
  • Rituximab — DRUG
    375 mg/m2 IV days 1 and 7 over 4 to 8 hours
  • Carmustine — DRUG
    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)
  • Etoposide — DRUG
    60 mg/kg over 4 hours day -4 and alternatively VP-16 2 Gm/m² may be used (for mobilization)
  • Filgrastim — DRUG
    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
  • Anti-thymocyte globulin (ATG) — DRUG
    1.5 mg/kg/day for 5 days
  • Cyclosporine — DRUG
    5.0 mg/kg twice daily from day -3 until after day +56
  • Mycophenolate mofetil (MMF) — DRUG
    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.
  • Cyclophosphamide — DRUG
    100 mg/kg will be administered over 2 hours on day -2
  • Acetaminophen — DRUG
    Pre-medication for rituximab and PBPC infusion. Administered at 650 mg by mouth 1 hour prior to infusion
  • Diphenhydramine — DRUG
    Pre-medication for rituximab and PBPC infusion. Administered at 50 mg intravenous 1 hour prior to infusion
  • Hydrocortisone — DRUG
    Pre-medication for the PBPC infusion. Administered at 100 mg intravenous 1 hour prior to infusion
  • Methylprednisolone — DRUG
    Anti-reaction medication for the ATG infusion. Administered at 1 mg/kg, Day-11 to Day-7

Study Details

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.

Key Dates

Start date
Oct 31, 2006
Status verified
May 2018
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: Auto-HCT followed by Allo-HCT for Poor-risk DLBCL
    Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT). Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning \[total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)\] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF). Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; \& methylprednisolone.

Primary Outcome Measure

Event-free Survival (EFS) Per Protocol [ Time Frame: 48 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

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Stanford University School of Medicine· Stanford, CA

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