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Stem Cell Transplantation

Stem Cell Transplant for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Keith Stockerl-Goldstein, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Full hematologic recovery following Auto HCT including: Absolute neutrophil count (ANC) >1000 µl, Platelet count of ≥50,000 µl independent of transfusion for >7 days, Available matched related or unrelated donor. Selected donor must be a complete match or have only a single antigen mismatch

Age 18 to 70 years

Must not have

Known or suspected progressive disease following autologous SCT

Prior radioimmunotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new two-step approach to treating high-risk non-Hodgkin's lymphoma. First, the patient's own blood cells are transplanted. Then, a transplant from another individual is performed. The goal is to improve the chances for long-term control of lymphoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune system reactions due to Anti-thymocyte globulin, increased infection risk from immunosuppressants like Tacrolimus and Mycophenolate mofetil, as well as potential organ damage related to Solumedrol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 70 years old.

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My condition is confirmed non-Hodgkin's lymphoma.

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My kidney function tests are within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had radioimmunotherapy before.

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I am currently on antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stem cell infusion

2002

Completed Phase 3

~60

Anti-thymocyte globulin

2010

Completed Phase 4

~470