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

27. srpna 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

66

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Lék: DCDS0780A
Participants will receive escalating doses of DCDS0780A as intravenous infusion.
Experimentální: 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).
Lék: DCDS0780A
Participants will receive escalating doses of DCDS0780A as intravenous infusion.
Lék: Rituximab
Participants will receive rituximab at a dose of 375 mg/m^2 of body surface area as intravenous infusion.
Ostatní jména:
  • Rituxan®
  • MabThera®
Experimentální: 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).
Lék: DCDS0780A
Participants will receive escalating doses of DCDS0780A as intravenous infusion.
Lék: Obinutuzumab
Participants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.
Ostatní jména:
  • GA101
  • Gazyva™
  • Gazyvaro™

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Number of Participants with Adverse Events
Časové okno: 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
Časové okno: Days 1 to 21
Days 1 to 21
Maximum Tolerated Dose (MTD) of DCDS0780A
Časové okno: Days 1 to 21
Days 1 to 21
Recommended Phase 2 Dose (RP2D) of DCDS0780A
Časové okno: Days 1 to 21
Days 1 to 21

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Area Under the Serum Concentration-Time Curve (AUC) for DCDS0780A Total Antibody
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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])
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline up to 1 year
Baseline up to 1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. srpna 2015

Primární dokončení (Aktuální)

12. července 2019

Dokončení studie (Aktuální)

12. července 2019

Termíny zápisu do studia

První předloženo

21. května 2015

První předloženo, které splnilo kritéria kontroly kvality

21. května 2015

První zveřejněno (Odhad)

25. května 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. srpna 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. srpna 2019

Naposledy ověřeno

1. srpna 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GO29687

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Non-Hodgkinův lymfom

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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