Using stem cell transplant and Polatuzumab Vedotin for treating B-cell lymphomas
Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
This study is testing if a stem cell transplant followed by a new drug called Polatuzumab Vedotin can help people with different types of B-cell lymphomas feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 12 Years to 70 Years |
| Sex | All |
| Sponsor | New York Medical College Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Polatuzumab |
| Locations | 1 site (Valhalla, New York) |
| Trial ID | NCT04491370 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of autologous stem cell transplant (ASCT) followed by Polatuzumab Vedotin in patients with various types of B-cell non-Hodgkin lymphoma and Hodgkin lymphoma. Participants will undergo one of two conditioning regimens before receiving ASCT, and if they respond positively, they will receive Polatuzumab Vedotin every 21 days for a total of 8 doses. The study aims to evaluate the treatment's efficacy and safety, with follow-up assessments occurring every four months for approximately two years.
Who should consider this trial
Good fit: Ideal candidates include patients with specific types of B-cell lymphomas who have experienced relapses and have a performance status of 50% or higher.
Not a fit: Patients who are not eligible due to poor performance status or those who have not fully recovered from prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve outcomes for patients with difficult-to-treat B-cell lymphomas.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this treatment strategy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valhalla, New York
- New York Medical Center — Valhalla, New York, United States (Recruiting)
Study contacts
- Study coordinator: Lauren Harrison, RN
- Email: lauren_harrison@nymc.edu
- Phone: 6172857844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.