Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma

Part of paid clinical trials in Valhalla, New York.

Sponsor
New York Medical College
Study ID
NCT04491370
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Lymphoma
  • Burkitt Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Richter Syndrome
  • Transformed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab vedotin — DRUG
    All patients will receive a myeloablative conditioning regimens (BEAM or CBV, as selected by the treating physician) followed by autologous stem cell transplant (ASCT). All patients on this study will receive an autologous stem cell transplant (ASCT) on Day 0 followed by supportive care including the drugs sargarmostim and filgrastim until blood counts are stable. If a complete, partial, or stable response is achieved following ASCT, the patient will receive an IV dose of Polatuzumab Vedotin once every 21 days until he/she receives 8 doses.

Study Details

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.

Key Dates

Start date
Aug 1, 2021
Status verified
Apr 2026
Primary completion
Aug 15, 2026
Completion
Aug 15, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab vedotin
    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.

Primary Outcome Measure

Safety and tolerability [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York Medical CenterValhallaNew York10595
Kayleigh Klose, MD
[email protected]

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By research site
New York Medical Center· Valhalla, NY

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