Clinical trial · Interventional
Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
NCT00481832CI-TRIAL-00031683terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual Factor
Summary
Brief summary (as posted)
The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.
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 (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic stem cell transplantation (allo-HSCT) | Procedure | — | UNRESOLVED |
| Antithymocyte globulin | Drug | — | UNRESOLVED |
| Autologous hematopoietic stem cell transplantation (auto-HSCT) | Procedure | — | UNRESOLVED |
| BCNU | Drug | Carmustine | ALIAS |
| CD34+ Cells | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine | Drug | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- T & B Cell Mobilization Auto & Allo HCT
- description
- A transplant regimen that conditions the subjects using total lymphoid irradiation (TLI) and anti-thymocyte globulin(ATG) which will reduce acute graft-vs-host disease to negligible rates while maintaining the anti-tumor graft vs lymphoma GvL benefit. Along with TLI/ATG regiment; Solumedrol will be used as pre-medication and anti-emetic for any side effects. For stem cell mobilization, participants will be given either B Cell NLH or T Cell NHL. Before the filgrastim (G-CSF) mobilized PBPC infusion: acetaminophen, diphenhydramine and hydrocortisone will also be given as another set of pre-medications. BCNU, Etoposide, and Cyclophosphamide will be used as a preparative regimen. Cyclosporine and mycophenolate mofetil will be administered as an immunosuppressant after transplantation. Lastly, rituximab will be infused at the end of the transplantation regimen.
- interventionNames
- Drug: Cyclophosphamide
- Drug: BCNU
- Drug: Etoposide
- Drug: Filgrastim
- Drug: Antithymocyte globulin
- Drug: Cyclosporine
- Drug: Mycophenolate mofetil
- Drug: Rituximab
- Procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT)
- Procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Procedure: Total lymphoid irradiation
- Drug: CD34+ Cells
- Drug: Solu-Medrol
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 * Relapse after achieving initial remission or failure to achieve initial remission. * KPS \> 70% * Matched related or unrelated donor identified and available. Donor must be a complete match or have only a single allele mismatch. * Recent Bone marrow biopsy and cytogenetic analysis * Patients must have a pretreatment serum bilirubin \< 2 x the institutional ULN, a serum creatinine \< 2 x the institutional ULN and measured or estimated creatinine clearance \> 50 cc/min by the following formula (all tests must be performed within 28 days prior to mobilization ): Estimated Creatinine Clearance = (140 age) X WT(kg) X 0.85 if female 72 X serum creatinine(mg/dl). * Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease. * Patients must have an echocardiogram or MUGA scan within 42 days of registration. If the ejection fraction is \< 40%, the patient will not be eligible. If the ejection fraction is 40-50%, patients must have an exercise echocardiogram or dobutamine-echo with a normal response to exercise. * Patients must have a corrected diffusion capacity \> 50% prior to the autologous transplant and \> 40% prior to the allogeneic transplant. * Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide are not eligible. * 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: * Pregnant or breast-feeding women are ineligible due to the known birth defects association with the treatments used in this study. * Patients known to be human immunodeficiency virus (HIV)-positive are ineligible because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. * Patients with prior maligancies diagnosed \> 5 years ago without evidence of disease are eligible. Patients with a prior malignancy treated \< 5 years ago but have a life expectancy of \> 5 years for that malignancy are eligible. * Patients with uncontrolled infection. * No prior autologous or allogeneic hematopoietic cell transplantation. Donor Selection/Evaluation: * Related or unrelated HLA identical donors who are in good health and have no contra-indication to donation. * No contra-indication for the donor to collection by apheresis of mononuclear cells mobilized by G-CSF at a dose of 16 µg/kg of body weight. * Virology testing including CMV, HIV, EBV, HTLV, RPR, Hepatitis A, B and C will be performed within 30 days of donation. * No prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the donor has been disease-free for five years
References
Publications (0)
Data not yet available
No reference posted for this study.