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Active, not recruitingNCT00882895Updated Feb 2, 2026

Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma

A Phase 2 interventional study of Stem cell infusion and TLI in Lymphoma, Non-Hodgkin, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

The approach to recurrent or primary refractory non-Hodgkin's lymphoma has been to treat patients with second-line chemotherapy (usually 2-3 courses) for the purposes of cytoreduction and to establish sensitivity to chemotherapy. Thereafter, peripheral blood progenitor cells have been mobilized with cyclophosphamide and granulocyte colony stimulating factor, apheresed and cryopreserved. Unfortunately, there are subgroups of patients with poor outcomes using autologous transplantation including those with transformed lymphoma as well as patients who do not attain a minimal disease state due to chemoresistant disease.

In a group of 17 patients with transformed lymphoma who received autologous transplants at Stanford University, the median EFS and OS were 1.48 and 2.7 years respectively with a 7-year survival of only 20%. In comparison, patients with chemosensitive follicular lymphoma who received the same regimen also had a poor median EFS of 1.3 years, but the median survival was 6.7 years. The outcomes for patients with chemotherapy-resistant relapsed NHL is also poor with EFS in the range of 20% in many studies of autologous transplantation.

These groups of patients have limited disease control and survival with standard chemotherapy regimens, and although they often have excellent cytoreduction with the high-dose chemotherapy regimen, relapse remains the primary cause of treatment failure. The current trial utilizes a similar approach that we have taken with patients with multiple myeloma, who appear to benefit from an allogeneic graft-versus-tumor effect, using a combined autologous and non-myeloablative allogeneic transplant regimen to reduce transplant-related complications. In addition, there are limited reports of using an autologous/allogeneic approach for lymphoma patients using non-myeloablative allogeneic transplants. Eligible patients will be treated with high-dose chemotherapy using BCNU, etoposide, cytarabine and melphalan with autologous hematopoietic cell support as a method of cytoreduction. Approximately 60-120 days after the autologous transplant, patients will receive an allogeneic transplant using a preparative regimen of total lymphoid irradiation and anti-thymocyte globulin in an attempt to develop a graft-versus-lymphoma effect.

02

Conditions studied

  • Lymphoma, Non-Hodgkin

Keywords

  • Lymphoma, Non-Hodgkin
  • Transplantation, Autologous
  • Transplantation, Homologous
  • Total Lymphoid Irradiation
  • Anti-thymocyte globulin
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 18 is below the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria

  • Age 18 to 70 years.
  • Histologically proven non-Hodgkin's lymphoma

  • High risk disease including at least one of the following:

    • Relapsed or refractory disease
    • Transformed lymphoma
    • Aggressive T-cell lymphoma
    • Failure to achieve completed remission (CR) following Auto SCT
    • Less than a 20% chance of event-free survival from autologous transplant determined by the treating physician and the Principal Investigator
  • ECOG performance status \< or = 2

  • Underwent Autologous SCT 60-120 days prior to registration including:

    • BEAM conditioning (BCNU: 300 mg/m2 IV day -7, Etoposide: 100 mg/m2 IV BID days -6,-5,-4,-3, Cytarabine: 100 mg/m2 IV BID days -6,-5,-4,-3, Melphalan: 140 mg/m2 IV day -2)
    • Minimum of 2 x 106 CD34+ cells/kg infused

  • 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.
  • Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control.
  • Bone marrow comprising of \< 10% lymphoma on most recent biopsy/aspiration (within 9 months of Allo transplant; may have been performed prior to autologous transplant).
  • Serum bilirubin \< or = 2 x the institutional ULN

  • Serum creatinine \< or = 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula

    • Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female 72X serum creatinine(mg/dl).
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

  • Prior autologous or allogeneic hematopoietic cell transplantation (other than autologous SCT 60-120 days prior to registration)
  • Prior radioimmunotherapy
  • Known or suspected progressive disease following autologous SCT
  • Additional treatment for NHL administered from time of autologous SCT through registration
  • Pregnant or breast-feeding women (due to the known birth defects association with the treatments used in this study)
  • Human immunodeficiency virus (HIV)-positive (the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population.)
  • Any prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
  • Active infection requiring oral or intravenous antibiotics.

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this trial.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Allogeneic Transplant

    * 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)

    Procedure: Stem cell infusion · Procedure: TLI · Drug: Anti-thymocyte globulin · Drug: Solumedrol · Drug: Tacrolimus · Drug: Mycophenolate mofetil

Interventions

  • ProcedureStem cell infusion
  • ProcedureTLI
  • DrugAnti-thymocyte globulin

    Also known as: ATG, Atgam, Thymoglobulin

  • DrugSolumedrol

    Also known as: Medrol, Solu-Medrol

  • DrugTacrolimus

    Also known as: FK-506, Prograf, Advagraf, Protopic

  • DrugMycophenolate mofetil

    Also known as: MMF, CellCept, Myfortic

06

What researchers measure

Primary outcomes

  1. Determine the event free survival

    Time frame: Up to 10 years from transplant

  2. Determine the toxicities

    Time frame: Day 100

Secondary outcomes

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

    Time frame: Day 56, Day 100, Day 180, and Day 365

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

    Time frame: Up to 10 years

  3. To evaluate the overall and non-relapse mortality rate.

    Time frame: Up to 10 years

  4. Incidence of chemotherapy-associated pneumonitis

    Time frame: Day 100

07

Study locations

1 site
  • Washington University
    St Louis, Missouri 63110, United States
08

References and documents

Publications

  • Maloney DG, Molina AJ, Sahebi F, Stockerl-Goldstein KE, Sandmaier BM, Bensinger W, Storer B, Hegenbart U, Somlo G, Chauncey T, Bruno B, Appelbaum FR, Blume KG, Forman SJ, McSweeney P, Storb R. Allografting with nonmyeloablative conditioning following cytoreductive autografts for the treatment of patients with multiple myeloma. Blood. 2003 Nov 1;102(9):3447-54. doi: 10.1182/blood-2002-09-2955. Epub 2003 Jul 10. PubMed 12855572 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00882895
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Apr 17, 2009
Start date
May 5, 2009
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Feb 2, 2026

Study contacts

Keith Stockerl-Goldstein, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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