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New treatment option for B-cell Lymphoma
Official title Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT04491370
What this study is testing
What is Polatuzumab vedotin?
Polatuzumab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 70
You may be able to join if
- Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed...
- 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...
- 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...
You likely can't join if
- 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...
- Patient must not have an uncontrolled infection.
See the full eligibility 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.
- Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Valhalla, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Valhalla, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.