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Lymphoma, Non-HodgkinPhase 2NCT00882895

Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma

A Phase 2 study testing Stem cell infusion, TLI and Anti-thymocyte globulin in people with Lymphoma, Non-Hodgkin, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
Stem cell infusion, TLI and Anti-thymocyte globulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
5 May 2009to 1 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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.
  • -Both men and women and members of all races and ethnic groups are eligible for this trial.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma

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.

Being tested
Stem cell infusion, TLI, Anti-thymocyte globulin, Solumedrol, Tacrolimus
Keywords
Lymphoma, Non-Hodgkin, Transplantation, Autologous, Transplantation, Homologous, Total Lymphoid Irradiation, Anti-thymocyte globulin
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem cell infusionProcedure or surgery

  • TLIProcedure or surgery

  • Anti-thymocyte globulinDrug

    Also called ATG, Atgam, Thymoglobulin

  • SolumedrolDrug

    Also called Medrol, Solu-Medrol

  • TacrolimusDrug

    Also called FK-506, Prograf, Advagraf, Protopic

  • Mycophenolate mofetilDrug

    Also called MMF, CellCept, Myfortic

Study groups in NCT00882895
Study groupRoleWhat they receive
Allogeneic TransplantExperimental* 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)
Receives: Procedure: Stem cell infusion; Procedure: TLI; Drug: Anti-thymocyte globulin; Drug: Solumedrol; Drug: Tacrolimus; Drug: Mycophenolate mofetil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the event free survival

    Measured: Up to 10 years from transplant

  2. Determine the toxicities

    Measured: Day 100

Secondary outcomes (4)

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

    Measured: Day 56, Day 100, Day 180, and Day 365

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

    Measured: Up to 10 years

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

    Measured: Up to 10 years

  4. Incidence of chemotherapy-associated pneumonitis

    Measured: Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2009 (estimated)
  2. Study start5 May 2009
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00882895
Sponsor's protocol ID
09-0042 / 201101864
Status last verified
Jan 2026
First submitted
15 Apr 2009
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stem cell infusion, TLI and Anti-thymocyte globulin in people with Lymphoma, Non-Hodgkin, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the event free survival (time frame: Up to 10 years from transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00882895, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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