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A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

27 agosto 2019 aggiornato da: Hoffmann-La Roche

An Open-label, Multicenter, Phase 1/1b Dose Escalation Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Preliminary Efficacy of DCDS0780A, Alone or in Combination With Rituximab, or Obinutuzumab, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

66

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Duarte, California, Stati Uniti, 91010
        • City of Hope National Medical Center
      • Stanford, California, Stati Uniti, 94305-5820
        • Stanford Cancer Center
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80012
        • Medical Center of Aurora; Rocky Mountain Cancer Centers
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Georgetown University Medical Center Lombardi Cancer Center
    • Florida
      • Sarasota, Florida, Stati Uniti, 34232
        • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
    • New York
      • New York, New York, Stati Uniti, 10016
        • New York University Cancer Cen
    • Oregon
      • Eugene, Oregon, Stati Uniti, 97401-8122
        • Willamette Valley Cancer Ctr - 520 Country Club

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Life expectancy of at least 12 weeks
  • Histologically confirmed B-cell non-Hodgkin's lymphoma that has relapsed after or failed to respond to at least one prior treatment regimen and for which no suitable therapy of curative intent or higher priority exists
  • A clinical indication for treatment as determined by the investigator
  • Availability of archival or freshly collected tumor tissue before study enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Fasting (greater than or equal to [>=] 8 hours) glucose less than or equal to (<=) 160 milligrams per deciliter (mg/dL)
  • Participants requiring anti-diabetic medications must be on a stable dose and regimen for >=4 weeks
  • Adequate hematologic function without growth factor or transfusion support
  • For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods as specified in protocol
  • For men: agreement to remain abstinent or use a condom plus an additional contraceptive method as specified in protocol

Exclusion Criteria:

  • Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
  • Treatment with radiotherapy, any chemotherapeutic agent, systemic steroids used as an anti-neoplastic agent, or any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
  • Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
  • Prior allogeneic stem cell transplant
  • Current or history of CNS lymphoma
  • Current Grade greater than (>) 1 toxicity (except alopecia and anorexia) from prior therapy
  • Current Grade >1 peripheral neuropathy from any cause
  • Glycosylated hemoglobin (HbA1c) >=7.5 percent (%)
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Prior irradiation to lung fields
  • Clinically significant pulmonary disease
  • Recent major surgery within 4 weeks prior to Cycle 1, Day 1, other than superficial lymph node biopsies for diagnosis
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Presence of positive test results for hepatitis B (hepatitis B surface antigen [HbsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C (hepatitis C virus [HCV] antibody)
  • Known history of human immunodeficiency virus (HIV) seropositive status
  • Women who are pregnant or lactating or intending to become pregnant during the study
  • Any abnormal laboratory values as specified in protocol
  • Requirement for any excluded medication as specified in protocol
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications, including inadequately controlled diabetes or significant cardiovascular disease
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
  • Participants in Phase 1b Stage Only: Vaccination with live vaccines within 6 months before Cycle 1, Day 1

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: DCDS0780A Monotherapy
Participants will receive escalating doses of DCDS0780A as intravenous infusion as monotherapy on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
Droga: DCDS0780A
Participants will receive escalating doses of DCDS0780A as intravenous infusion.
Sperimentale: DCDS0780A + Rituximab
Participants will receive escalating doses of DCDS0780A on Day 2 of Cycles 1 and 2, and from Cycle 3 onwards on Day 1 of each 21-day cycle in combination with rituximab at a dose of 375 milligrams per square meter (mg/m^2) of body surface area as intravenous infusion on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
Droga: DCDS0780A
Participants will receive escalating doses of DCDS0780A as intravenous infusion.
Droga: Rituximab
Participants will receive rituximab at a dose of 375 mg/m^2 of body surface area as intravenous infusion.
Altri nomi:
  • Rituxan®
  • MabThera®
Sperimentale: DCDS0780A + Obinutuzumab
Participants will receive escalating doses of DCDS0780A on Day 2 of Cycles 1 and 2, and from Cycle 3 onwards on Day 1 of each 21-day cycle in combination with obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion on Days 1, 8, and 15 of Cycle 1, and from Cycle 2 onwards on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
Droga: DCDS0780A
Participants will receive escalating doses of DCDS0780A as intravenous infusion.
Droga: Obinutuzumab
Participants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.
Altri nomi:
  • GA101
  • Gazyva™
  • Gazyvaro™

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of Participants with Adverse Events
Lasso di tempo: Baseline up to 30 days after the last dose of study drug (up to 1 year)
Baseline up to 30 days after the last dose of study drug (up to 1 year)
Percentage of Participants with Dose-Limiting Toxicities
Lasso di tempo: Days 1 to 21
Days 1 to 21
Maximum Tolerated Dose (MTD) of DCDS0780A
Lasso di tempo: Days 1 to 21
Days 1 to 21
Recommended Phase 2 Dose (RP2D) of DCDS0780A
Lasso di tempo: Days 1 to 21
Days 1 to 21

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area Under the Serum Concentration-Time Curve (AUC) for DCDS0780A Total Antibody
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to end of treatment (ET) visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Maximum Observed Serum Concentration (Cmax) for DCDS0780A Total Antibody
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Total Clearance (CL) of DCDS0780A Total Antibody
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Half-life (t1/2) of DCDS0780A Total Antibody
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Volume of Distribution Under Steady-State Conditions (Vss) of DCDS0780A Total Antibody
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Area Under the Plasma Concentration-Time Curve (AUC) for DCDS0780A Conjugate (Antibody-Conjugated Monomethyl Auristatin E [acMMAE])
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Maximum Observed Plasma Concentration (Cmax) for acMMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Total Clearance (CL) of acMMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Half-life (t1/2) of acMMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Volume of Distribution Under Steady-State Conditions (Vss) of acMMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Area Under the Plasma Concentration-Time Curve (AUC) for Unconjugated Monomethyl Auristatin E (MMAE)
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Maximum Observed Plasma Concentration (Cmax) for Unconjugated MMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Total Clearance (CL) of Unconjugated MMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Half-life (t1/2) of Unconjugated MMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Volume of Distribution Under Steady-State Conditions (Vss) of Unconjugated MMAE
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Monotherapy arm: Pre-infusion, 0.5, 4, hours after end of infusion on Cycle 1 Day 1; at Cycle 1 Days 2, 4 (or 5), 8, 11 (or 12), 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 2-4 Day 1, Cycle 2-4 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2 and 4 months after ET.

Combination therapy arm: Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 2; at Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 2, Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, Cycle 12, and every 4th cycle thereafter up to ET visit.

Pre-infusion = 0-4 hours before infusion; infusion duration = 90 minutes for first infusion and 30 minutes for other infusions, ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Obinutuzumab Serum Concentration
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 1; Cycle 1 Days 4 (or 5); Pre-infusion and 0.5 hours after end of infusion on Cycle 1 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 1; Pre-infusion and 0.5 hours after end of infusion on Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2, 4, 6 months after ET.

Pre-infusion = 0-4 hours before infusion; infusion rate = 50 milligrams per hour initially (to be adjusted in case of reactions), ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Rituximab Serum Concentration
Lasso di tempo: Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)

Pre-infusion, 0.5 hours after end of infusion on Cycle 1 Day 1; Cycle 1 Days 4 (or 5), 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycle 2 Day 1; Pre-infusion and 0.5 hours after end of infusion on Cycles 3-4 Day 1; Cycles 3-4 Days 8, 15; Pre-infusion and 0.5 hours after end of infusion on Cycles 5-8, 12, and every 4th cycle thereafter up to ET visit; 2, 4, 6 months after ET.

Pre-infusion = 0-4 hours before infusion; infusion rate = 50 milligrams per hour initially (to be adjusted in case of reactions), ET = 30 days after last dose (up to 1 year), cycle length = 21 days.
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Percentage of Participants with Anti-DCDS0780A Antibodies
Lasso di tempo: Baseline up to 2 to 4 months after last dose (up to 16 months)
Baseline up to 2 to 4 months after last dose (up to 16 months)
Absolute Lymphocyte Count
Lasso di tempo: Cycle 1 Day 1 (Baseline); Day 1 of Cycles 4, 8, and every 4 cycles thereafter up to ET visit (up to 1 year); follow-up (up to 3.4 years)
Cycle 1 Day 1 (Baseline); Day 1 of Cycles 4, 8, and every 4 cycles thereafter up to ET visit (up to 1 year); follow-up (up to 3.4 years)
Change from Baseline in Intra-Patient Absolute Lymphocyte Counts
Lasso di tempo: Cycle 1 Day 1 (Baseline); Day 1 of Cycles 4, 8, and every 4 cycles thereafter up to ET visit (up to 1 year); follow-up (up to 3.4 years)
Cycle 1 Day 1 (Baseline); Day 1 of Cycles 4, 8, and every 4 cycles thereafter up to ET visit (up to 1 year); follow-up (up to 3.4 years)
Time to CD19+ B-Cell Count Recovery to Baseline Value
Lasso di tempo: Cycle 1 Day 1 (Baseline); Day 1 of Cycles 4, 8, and every 4 cycles thereafter up to ET visit (up to 1 year); follow-up (up to 3.4 years)
Cycle 1 Day 1 (Baseline); Day 1 of Cycles 4, 8, and every 4 cycles thereafter up to ET visit (up to 1 year); follow-up (up to 3.4 years)
Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) Assessed According to Lugano Classification
Lasso di tempo: Baseline up to first occurrence of disease progression or death from any cause within 30 days after the last dose of study drug (up to 1 year)
Baseline up to first occurrence of disease progression or death from any cause within 30 days after the last dose of study drug (up to 1 year)
Duration of Response Assessed According to Lugano Classification
Lasso di tempo: From the first occurrence of a documented objective response (CR or PR) to the time of relapse or death from any cause (up to 1 year)
From the first occurrence of a documented objective response (CR or PR) to the time of relapse or death from any cause (up to 1 year)
Progression-Free Survival (PFS) Assessed According to Lugano Classification
Lasso di tempo: Baseline up to first occurrence of disease progression or death from any cause within 30 days after the last dose of study drug (up to 1 year)
Baseline up to first occurrence of disease progression or death from any cause within 30 days after the last dose of study drug (up to 1 year)
Relative Dose Intensity (DI) Calculated as Ratio of Amount of Drug Actually Administered to the Amount Planned
Lasso di tempo: Baseline up to 1 year
Baseline up to 1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 agosto 2015

Completamento primario (Effettivo)

12 luglio 2019

Completamento dello studio (Effettivo)

12 luglio 2019

Date di iscrizione allo studio

Primo inviato

21 maggio 2015

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2015

Primo Inserito (Stima)

25 maggio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GO29687

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sedi

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