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Stem Cell Transplant + Polatuzumab for Lymphoma

Phase 1 & 2

Recruiting

Led By Aliza Gardenswartz, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Age Maximum Serum Creatinine (mg/dL) Male Female

Must not have

Patient must not have an uncontrolled infection.

Patient must not have ≥ Grade 3 neuropathy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different ways to prepare patients for a stem cell transplant, and whether a new drug can help keep the cancer from coming back.

Who is the study for?

This trial is for patients with various types of B-cell and Hodgkin Lymphoma who have had a relapse or are not responding well to initial treatments. They must be over 16, have a life expectancy greater than 6 weeks, and show adequate organ function. Patients can't join if they're pregnant, breastfeeding, have severe neuropathy, active CNS lymphoma, uncontrolled infections or are using other investigational drugs.

What is being tested?

The study tests Polatuzumab Vedotin in patients post-autologous stem cell transplant (ASCT). Participants will first undergo one of two chemotherapy regimens before ASCT. If they respond well to ASCT, they'll receive Polatuzumab Vedotin every three weeks for up to eight doses.

What are the potential side effects?

Polatuzumab Vedotin may cause side effects such as nerve damage (neuropathy), infusion reactions similar to allergic responses during drug administration, liver problems indicated by abnormal blood tests results and potentially low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most of my daily activities by myself.

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My kidney function, measured by creatinine levels, is within the normal range for my age and gender.

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My liver enzymes are within normal limits for my age.

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I have recovered from side effects of my previous cancer treatments.

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I am at least 16 years old.

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My organs are functioning well.

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I have enough stem cells collected and stored for my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections that aren't responding to treatment.

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I do not have severe nerve damage.

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I do not have active brain lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability

Secondary study objectives

EFS, PFS, and OS

ORR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Polatuzumab vedotinExperimental Treatment1 Intervention

Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.

0 / 10Eligibility criteria met