Clinical trial · Interventional
Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-thymocyte globulin | Drug | — | UNRESOLVED |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
| Solumedrol | Drug | — | UNRESOLVED |
| Stem cell infusion | Procedure | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| TLI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic Transplant
- description
- * 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)
- interventionNames
- Procedure: Stem cell infusion
- Procedure: TLI
- Drug: Anti-thymocyte globulin
- Drug: Solumedrol
- Drug: Tacrolimus
- Drug: Mycophenolate mofetil
Primary outcomes (2)
- measure
- Determine the event free survival
- timeFrame
- Up to 10 years from transplant
- measure
- Determine the toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDMaloney 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. PMID 12855572