Double transplant strategy targets tough lymphoma
NCT ID NCT00882895
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tests a two-step transplant approach for people with high-risk non-Hodgkin's lymphoma. First, patients receive a transplant using their own stem cells, followed by a second transplant from a donor. The goal is to improve long-term disease control. The trial enrolled 18 adults aged 18 to 70 with aggressive or relapsed lymphoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cell transplant (autologous followed by non-myeloablative allogeneic)
- What this could lead to
- If it works, this two-step transplant approach could offer better long-term control of high-risk non-Hodgkin's lymphoma.
- What could go wrong
- This is a small, early-phase trial with only 18 participants, so results may not apply broadly. The procedure carries risks like graft-versus-host disease and infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
18 people
The number who actually took part.
- Started
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May 2009
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University
St Louis, Missouri, 63110, United States
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