NCT04491370 Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
| NCT ID | NCT04491370 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | New York Medical College |
| Condition | B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2021-08-01 with a primary completion date of 2026-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.
Eligibility Criteria
Inclusion Criteria: * Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma. * Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having attained a CR, PR, or stable disease post reinduction therapy. * Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients \> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score. * Life Expectancy Patients must have a life expectancy of \> 6 weeks. * Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea). 2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. * Organ Function Requirements Adequate Renal Function Defined As: * Creatinine clearance or radioisotope GFR \> 60 mL/min/1.73 m2 or * A serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female * 12 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4 * 16 years 1.7 1.4 * Adequate Liver Function Defined As: * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and * SGOT (AST) or SGPT (ALT) \< 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma. * Adequate Cardiac Function Defined As: * Shortening fraction of \> 27% by echocardiogram, or * Ejection fraction of \> 50% by radionuclide angiogram. * Adequate Pulmonary Function Defined As: • Normal respiratory rate for age and a pulse oximetry \> 94% on room air unless due to underlying malignancy. * Peripheral Blood Stem Cell Collection • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC collected and cryopreserved prior to start of myeloablative conditioning * All patients and/or their parents or legal guardians must sign a written informed consent. Exclusion Criteria: * Patient may not have had a prior stem cell transplant * Patients must not have active CNS lymphoma * Other concurrent investigational agents for treatment of B-cell lymphoma * Pregnancy and/or active Breast Feeding * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. * Patient must not have an uncontrolled infection. * Patient must not have ≥ Grade 3 neuropathy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04491370 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 70 Years, studying B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04491370 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04491370 currently recruiting?
Yes, NCT04491370 is actively recruiting participants. Contact the research team at lauren_harrison@nymc.edu for enrollment information.
Where is the NCT04491370 trial being conducted?
This trial is being conducted at Valhalla, United States.
Who is sponsoring the NCT04491370 clinical trial?
NCT04491370 is sponsored by New York Medical College. The trial plans to enroll 20 participants.