A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

Browse trials for

• Lymphoma, Follicular 931

Keywords

• Non-Hodgkin lymphomas (NHLs)
• Indolent NHL
• B-cells NHL (B-NHL)
• Follicular lymphoma
• Odronextamab

Lymphoma, Follicular

931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.

This study's planned enrollment of 822 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Odronextamab

  Part 1 is a safety run-in. All participants will receive odronextamab. In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.

  Drug: Odronextamab

• Active comparator
  Rituximab + Investigator's Choice Chemotherapy

  Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.

  Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone/prednisolone · Drug: Bendamustine

Interventions

• DrugOdronextamab

  Administered per the protocol

  Also known as: REGN1979

• DrugRituximab

  Administered per the protocol

  Also known as: Rituxan

• DrugCyclophosphamide

  Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

  Also known as: Cytoxan

• DrugDoxorubicin

  Administered per the protocol as part of CHOP chemotherapy

  Also known as: Adriamycin

• DrugVincristine

  Administered per the protocol as part of CHOP, and CVP chemotherapy

  Also known as: Oncovin

• DrugPrednisone/prednisolone

  Administered per the protocol as part of CVP chemotherapy

  Also known as: Deltasone/Omnipred

• DrugBendamustine

  Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

  Also known as: Treanda

Primary outcomes

1. Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab

   Part 1

   Time frame: Up to 35 days

2. Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab

   Part 1

   Time frame: Up to 2 years

3. Severity of TEAEs of odronextamab

   Part 1

   Time frame: Up to 2 years

4. Complete Response at 30 months (CR30) as assessed by independent central review

   Part 2

   Time frame: Up to 30 months

Secondary outcomes

1. Concentrations of odronextamab in serum

   Part 1

   Time frame: Up to 30 months

2. Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab

   Part 1

   Time frame: Up to 30 months

3. Magnitude of ADAs to odronextamab

   Part 1

   Time frame: Up to 30 months

4. Objective response as assessed by the investigator

   Part 1

   Time frame: Up to 30 months

5. Progression-Free Survival (PFS) as assessed by independent central review

   Part 2

   Time frame: Up to 5 years

6. Event-Free Survival (EFS) as assessed by independent central review

   Part 2

   Time frame: Up to 5 years

7. Overall Survival (OS)

   Part 2

   Time frame: Up to 5 years

8. Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]

   Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

   Time frame: Up to 5 years

9. CR30 as assessed by local investigator

   Part 2

   Time frame: Up to 30 months

10. PFS as assessed by the local investigator

    Part 2

    Time frame: Up to 5 years

11. EFS as assessed by the local investigator

    Part 2

    Time frame: Up to 5 years

12. Objective response assessed by local investigator

    Part 2

    Time frame: Up to 30 months

13. Objective response assessed by independent central review

    Part 2

    Time frame: Up to 30 months

14. Duration Of Response (DOR) assessed by independent central review

    Part 2

    Time frame: Up to 5 years

15. DOR assessed by local investigator

    Part 2

    Time frame: Up to 5 years

16. Time To Next anti-lymphoma Treatment (TTNT)

    Part 2

    Time frame: Up to 5 years

17. Incidence of TEAEs

    Part 2

    Time frame: Up to 2 years

18. Severity of TEAEs

    Part 2

    Time frame: Up to 2 years

19. Odronextamab concentrations in serum during the induction period

    Part 2

    Time frame: Up to 30 months

20. Odronextamab concentrations in serum during the maintenance period

    Part 2

    Time frame: Up to 30 months

21. Occurrence of ADAs to odronextamab

    Part 2

    Time frame: Up to 30 months

22. Magnitude of ADAs to odronextamab

    Part 2

    Time frame: Up to 30 months

23. Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30

    Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

    Time frame: Up to 5 years

24. Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)

    Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

    Time frame: Up to 5 years

25. Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)

    Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

    Time frame: Up to 5 years

26. Change in Patient Global Impression of Severity (PGIS)

    Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).

    Time frame: Up to 5 years

27. Change in Patient Global Impression of Change (PGIC)

    Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.

    Time frame: Up to 5 years

28. Change in score of the GP5 item in the participant population

    Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

    Time frame: Up to 5 years

Related links

• OLYMPIA ↗

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code