Stem Cell Transplant for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByKeith Stockerl-Goldstein

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This is a research study testing a new approach to treating high-risk non-Hodgkin's lymphoma consisting of an autologous hematopoietic (blood) stem cell transplant (using a patient's own hematopoietic cells) followed by a non-myeloablative allogeneic transplantation (transplant from another individual). The investigators hypothesize that the addition of the second non-myeloablative transplant will improve the chances for long-term control of lymphoma.

Eligibility Criteria

This trial is for adults aged 18-70 with high-risk non-Hodgkin's lymphoma who've had a stem cell transplant using their own cells. They must be in partial remission, have a matched donor ready, and agree to birth control. Excluded are those with prior radioimmunotherapy, progressive disease post-transplant, HIV-positive individuals or other recent cancers.

Inclusion Criteria

My blood counts are stable after a stem cell transplant, and I have a suitable donor.

I am between 18 and 70 years old.

My condition is confirmed non-Hodgkin's lymphoma.

My kidney function tests are within the required range.

Exclusion Criteria

My condition worsened after a stem cell transplant using my own cells.

I have had radioimmunotherapy before.

I am currently on antibiotics for an infection.

Participant Groups

The study tests if adding a second stem cell transplant from another person after an initial self-donated transplant can better control lymphoma. It involves drugs like Anti-thymocyte globulin and Tacrolimus to help the body accept the new cells.

1Treatment groups

Experimental Treatment

Group I: Allogeneic TransplantExperimental Treatment6 Interventions

* TLI - 80 cGy on days -14, -11, -10, -9, -8, -7, -4, -3, -2, -1 * Anti-thymocyte globulin (ATG) 1.5 mg/kg on days -11, -10, -8, -7 * Solumedrol - 1 mg/kg on days -11, -10, -9, -8, -7 * Tacrolimus - beginning on day -3 with starting dose of 0.3 mg/kg PO BID. Will be continued per institutional guidelines. * Stem cell infusion - day 0 * Mycophenolate mofetil (MMF) - beginning on day 0 with dose of 15 mg/kg PO (5-10 hours after transplant)

Autologous Hematopoietic Stem Cell Transplantation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Autologous Hematopoietic Stem Cell Transplantation for: