Clinical trial · Interventional
Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma
Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell 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 phase II trial studies the side effects of cord blood-derived expanded allogeneic natural killer cells (umbilical cord blood natural killer \[NK\] cells), rituximab, high-dose chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. A stem cell transplant using stem cells from the patient or a donor may be able to replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells, rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Recurrent Follicular Lymphoma | Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Indolent Adult Non-Hodgkin Lymphoma | Indolent Adult Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Refractory Follicular Lymphoma | Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Indolent Adult Non-Hodgkin Lymphoma | Indolent Adult Non-Hodgkin Lymphoma |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Carmustine | Drug | Carmustine | ALIAS |
| Cord Blood-derived Expanded Allogeneic Natural Killer Cells | Biological | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, NK infusion, stem cell transplant)
- description
- See Detailed Description.
- interventionNames
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Carmustine
- Biological: Cord Blood-derived Expanded Allogeneic Natural Killer Cells
- Drug: Cytarabine
- Drug: Etoposide
- Biological: Filgrastim
- Drug: Lenalidomide
- Drug: Melphalan
- Biological: Rituximab
Primary outcomes (1)
- measure
- Treatment-related Mortality Within 30 Days (TRM30)
- timeFrame
- Up to 30 days
- description
- Participants that had Treatment-related mortality within 30 days.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with B-cell lymphoma who are candidates to autologous stem-cell transplantation: * Primary refractory or relapsed diffuse large B-cell lymphoma in response to salvage treatment * Primary refractory or relapsed follicular lymphoma or other indolent B-cell histology in response to salvage treatment * Chemosensitive mantle-cell lymphoma in first or later line of treatment * Estimated serum creatinine clearance \>= 60 ml/min and a normal serum creatinine for age * Serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) =\< 3 x upper limit of normal (ULN) * Total bilirubin and alkaline phosphatase (ALP) =\< 2 x ULN or =\< 3 x ULN for Gilbert's disease * Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion lung capacity (DLCO) (corrected for hemoglobin \[Hgb\]) \>= 50% of the predicted value * Left ventricular ejection fraction \>= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease * Performance status \< 2 (Eastern Cooperative Oncology Group \[ECOG\]) * Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential Exclusion Criteria: * Primary central nervous system (CNS) lymphoma * Grade \>= 3 non-hematologic toxicity from prior therapy that has not resolved to =\< grade (G) 1 * Prior whole brain irradiation * Active hepatitis B, either active carrier (hepatitis B surface antigen positive \[HBsAg +\]) or viremic (hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \>= 10,000 copies/mL, or \>= 2,000 IU/mL) * Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology * Active infection requiring parenteral antibiotics * Human immunodeficiency virus (HIV) infection * Radiation therapy in the month prior to enroll * Breastfeeding females
References
Publications (0)
Data not yet available