Phase 2
N=22
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
Mantle Cell Lymphoma · Recurrent Diffuse Large B-Cell Lymphoma · Recurrent Follicular Lymphoma · Recurrent Indolent Adult Non-Hodgkin Lymphoma · Refractory Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03019640 ↗Enrolled (actual)
22
Serious AEs
68.2%
Results posted
Feb 2023
Primary outcome: Primary: Treatment-related Mortality Within 30 Days (TRM30) — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Hematopoietic Stem Cell Transplantation (Procedure); Carmustine (Drug); Cord Blood-derived Expanded Allogeneic Natural Killer Cells (Biological); Cytarabine (Drug); Etoposide (Drug); Filgrastim (Biological); Lenalidomide (Drug); Melphalan (Drug); Rituximab (Biological)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Mortality Within 30 Days (TRM30) |
— | — |
| SECONDARY Number of Participants Who Survived |
16 | — |
Summary
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.
Eligibility Criteria
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) = = 50% of the predicted value
- Left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
- Performance status = 3 non-hematologic toxicity from prior therapy that has not resolved to = = 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
Data sourced from ClinicalTrials.gov (NCT03019640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.