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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the event free survival

Determine the toxicities

Secondary outcome measures

Incidence of chemotherapy-associated pneumonitis

To evaluate the incidence and extent of acute and chronic GVHD.

To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.

+1 more

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

Solumedrol

2009

Completed Phase 4

~400

Tacrolimus

2011

Completed Phase 4

~4740

Mycophenolate mofetil

2014

Completed Phase 4

~2350

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,691 Total Patients Enrolled

Keith Stockerl-Goldstein, MDPrincipal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

Media Library

Non-Hodgkin's Lymphoma Research Study Groups: Allogeneic Transplant

Non-Hodgkin's Lymphoma Clinical Trial 2023: Autologous Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT00882895 — Phase 2

Autologous Hematopoietic Stem Cell Transplantation (Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00882895 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process for this trial currently active?

"At this juncture, this clinical trial is not actively recruiting. The initial post was published on the 5th of May 2009 and the last edit happened on January 12th 2022. For those searching for other studies, there are 1,750 trials enrolling patients with lymphoma, diffuse presently and 373 studies related to Anti-thymocyte globulin that require participants."

Answered by AI

Does the eligibility criterion for this medical study impose an age restriction?

"This trial has established 18 years old as the lower limit for eligibility and requires that participants are younger than 70."

Answered by AI

How many people have the opportunity to participate in this clinical research?

"This clinical trial is no longer accepting patients. According to its timeline, it was first posted on May 5th 2009 and last modified on January 12 2022. Nonetheless, those seeking alternative trials may find success in the 1750 lymphoma studies or 373 Anti-thymocyte globulin investigations that are currently recruiting participants."

Answered by AI

To what degree is eligibility for this research project limited?

"This clinical trial is actively recruiting 18 individuals with lymphoma, ranging from the age of majority to 70. To qualify for consideration, patients must have relapsed or refractory disease, aggressive T-cell lymphoma, histologically proven non-Hodgkin's Lymphoma in transformation and a less than 20% chance of event free survival post autologous transplantation (as determined by their physician), an ECOG performance status no greater than 2 as well as having received BEAM conditioning prior to application. Furthermore they should possess an absolute neutrophil count above 1000 µl/L and at least 2 x 10^6"

Answered by AI

To what degree can Anti-thymocyte globulin jeopardize a patient's safety?

"The safety of anti-thymocyte globulin was assessed to be a 2, as Phase 2 trials are still in progress and there is evidence suggesting the drug's security but none indicating its efficacy."

Answered by AI

Are there any other experiments that have explored the use of Anti-thymocyte globulin?

"At present, 373 Anti-thymocyte globulin trials are underway with 71 in Phase 3. Though Philadelphia Pennsylvania is the epicentre of research for this drug, there exist 8190 other sites conducting studies on it."

Answered by AI

What condition does Anti-thymocyte globulin typically aim to alleviate?

"Anti-thymocyte globulin is often the recommended treatment for scalp structure, yet it can provide relief from numerous other afflictions including dermatitis, atopic eczema, multiple sclerosis and ulcerative colitis."

Answered by AI

Recent research and studies

BloodJournal

Allografting with Nonmyeloablative Conditioning Following Cytoreductive Autografts for the Treatment of Patients with Multiple Myeloma

Maloney, David G., Arthur J. Molina, Firoozeh Sahebi, Keith E. Stockerl-Goldstein, Brenda M. Sandmaier, William Bensinger, Barry Storer, et al.. 2003. “Allografting with Nonmyeloablative Conditioning Following Cytoreductive Autografts for the Treatment of Patients with Multiple Myeloma”. Blood. American Society of Hematology. doi:10.1182/blood-2002-09-2955.

clinicaltrials.govStudy

Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma

2009. "Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00882895.

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