Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Conditions

• Chronic Lymphocytic Leukemia
• Indolent Non-Hodgkin's Lymphoma
• Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Idelalisib — DRUG
  Idelalisib tablet administered orally
• Rituximab — DRUG
  Rituximab administered intravenously
• Bendamustine — DRUG
  Bendamustine administered intravenously
• Ofatumumab — DRUG
  Ofatumumab administered intravenously
• Fludarabine — DRUG
  Fludarabine administered orally
• Everolimus — DRUG
  Everolimus administered orally twice daily until disease progression
• Bortezomib — DRUG
  Bortezomib administered as a subcutaneous injection
• Chlorambucil — DRUG
  Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.
• Lenalidomide — DRUG
  Lenalidomide administered orally

Study Details

The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).

Key Dates

Start date

Mar 25, 2010

Status verified

Feb 2021

Primary completion

Apr 28, 2015

Completion

Apr 28, 2015

Study Design

Enrollment

241 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Idelalisib + Rituximab
  Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) will receive treatments as follows: Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 intravenously (IV) on Days 1, 8, 15 \& 22, Cycles 1 \& 2 Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2 Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2 Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m\^2 IV on Days 1, 8, 15, \& 22, Cycles 1 \& 2
• Experimental: Idelalisib + Rituximab + Bendamustine
  Participants with CLL, iNHL and mantle cell lymphoma (MCL) will receive treatments as follows: Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle from Cycles 1 - 6 Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6
• Experimental: Idelalisib + Bendamustine
  Participants with CLL and iNHL will receive treatments as follows: Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6 Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6 Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6 Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m\^2 IV on Days 1 \& 2 of each 28-day cycle, Cycles 1 - 6
• Experimental: Idelalisib + Ofatumumab
  Participants with CLL will receive treatments as follows: Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))
• Experimental: Idelalisib + Fludarabine
  Participants with CLL will receive treatments as follows: Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m\^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6
• Experimental: Idelalisib + Everolimus
  Participants with MCL will receive treatments as follows: Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle
• Experimental: Idelalisib + Bortezomib
  Participants with MCL will receive treatments as follows: Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m\^2 subcutaneously on Days 1, 8 \& 15 of each 28-day cycle
• Experimental: Idelalisib + Chlorambucil
  Participants with CLL will receive treatments as follows: Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12
• Experimental: Idelalisib + Rituximab + Chlorambucil
  Participants with CLL will receive treatments as follows: Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m\^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m\^2 orally once daily for 7 days every 28 days, Cycles 1 - 12
• Experimental: Idelalisib + Rituximab + Lenalidomide
  Participants with CLL and iNHL will receive treatments as follows: Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) \& Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of Cycle 1 \& Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) \& Days 1 - 21 of next five 28-day cycles Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) \& Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of Cycle 1 \& Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) \& Days 1 - 21 of next five 28-day cycles Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) \& Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m\^2 IV on Days 1 \& 8 of Cycle 1 \& Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) \& Days 1 - 21 of next five 28-day cycles

Primary Outcome Measure

Duration of Exposure to IDELA [ Time Frame: First dose date up to 12 months ]

Locations (11)

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