Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)

Conditions

• Post-transplant Lymphoproliferative Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Polatuzumab vedotin — DRUG
  Given at 1.8 mg/kg
• Rituximab — DRUG
  Given at 375 mg/m\^2
• CHP — DRUG
  Cyclophosphamide (750 mg/m\^2) + doxorubicin (50 mg/m\^2) + prednisone (100 mg days 2-6)

Study Details

This study will test polatuzumab vedotin in combination with rituximab in patients with treatment-naïve CD20-positive post-transplant lymphoproliferative disorder (PTLD) based on the established efficacy of polatuzumab vedotin in B-cell lymphomas and the inadequate response rate of PTLD to single-agent rituximab. The hypothesis is that this combination therapy will be safe, well-tolerated, and effective. If so, patients with PTLD will be able to be spared the toxicity of anthracycline-based chemotherapy. Additionally, the role of the tumor microenvironment and the role of anellovirus, a non-human pathogen virus, will be explored as prognostic markers in PTLD.

Key Dates

Start date

Oct 4, 2023

Status verified

May 2026

Primary completion

May 31, 2027

Completion

May 31, 2032

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Polatuzumab vedotin + Rituximab (Safety Lead-in Low Risk/Interim Complete Remission)
  * Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).
• Experimental: Polatuzumab vedotin + Rituximab (Expansion Low Risk/Interim Complete Remission)
  * Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show a complete response (and are therefore determined to be low risk) will continue to receive polatuzumab vedotin + rituximab on Day 1 of each 21-day cycle for 4 additional cycles (6 cycles of treatment total).
• Experimental: Polatuzumab vedotin + Rituximab + CHP (Safety Lead-in High Risk/Lack of Interim Complete Remission))
  * Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).
• Experimental: Polatuzumab vedotin + Rituximab + CHP (Expansion High Risk/Lack of Interim Complete Remission)
  * Cycle 1 (21 days) * Day 1: polatuzumab vedotin + rituximab * Day 8: rituximab * Day 15: rituximab * Cycle 2 (21 days) * Day 1: polatuzumab vedotin + rituximab * After Cycle 2, a response assessment will be performed. Patients who show anything other than a complete response (and are therefore determined to be high risk) will receive polatuzumab vedotin + rituximab + CHP (cyclophosphamide + doxorubicin + prednisone) on Day 1 of each 21-day cycle for 4 additional cycles, followed by 2 final cycles of CHP alone on Day 1 (8 cycles of treatment total).

Primary Outcome Measure

Frequency and severity of treatment-related adverse events (AEs) [ Time Frame: From start of treatment through 30 days after completion of treatment or initiation of alternative therapy (estimated to be 5-7 months) ]

Central Contacts

• Neha Mehta-Shah, M.D.
  314-747-7510
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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• Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
  PHASE1/PHASE2 · Not Yet Recruiting · University of Utah · Salt Lake City, Utah