Stem Cell Transplant and Polatuzumab for B-cell Lymphoma
Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
Recruiting
Phase 1Phase 2Interventional Study
B-cell LymphomaBurkitt LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaTransformed Non-Hodgkin LymphomaRichter SyndromeHodgkin Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
New York Medical College · Other
Who this trial is looking for
This trial is looking for patients with specific types of B-cell lymphoma. Participants will undergo a stem cell transplant followed by a treatment with Polatuzumab Vedotin if their condition improves after the transplant.
Are You a Good Fit for This Trial?
You may be able to join if
I have a type of B-cell lymphoma.
I have had a relapse or my disease did not respond to initial treatment.
I am well enough to participate (performance status ≥ 50%).
I expect to live more than 6 weeks.
I have recovered from any serious side effects of previous treatments.
I have adequate kidney, liver, heart, and lung function.
I can provide enough stem cells for the transplant.
I will sign consent to participate.
You may not be able to join if
I have had a stem cell transplant before.
I have active CNS lymphoma.
I am currently taking other investigational treatments for my lymphoma.
I am pregnant or breastfeeding.
I am sexually active and not using effective birth control.
I have an uncontrolled infection.
I have severe neuropathy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 fo…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.