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NCT01088048 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 1
Development phase
241
Enrollment target

NCT01088048: Completed Phase 1 study, sponsored by Gilead Sciences.

NCT01088048 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 241 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01088048, a Phase 1 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 1
Development phase
241 participants
Enrollment target

Study Summary

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).

Primary Outcome

Duration of exposure to IDELA was summarized using descriptive statistics.

Interventions

  • DRUG Fludarabine
  • DRUG Rituximab
  • DRUG Bendamustine
  • DRUG Idelalisib
  • DRUG Ofatumumab

Trial Details

FieldValue
Enrollment Target 241 participants
Start Date 2010-03-25
Est. Completion 2015-04-28
Phase Phase 1
Gilead Sciences

504 total trials

What the finished NCT01088048 record still lists

NCT01088048 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (302% higher).

The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.

NCT01088048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01088048 about?

NCT01088048 is a clinical study titled "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". 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 partic...

What is the current status of trial NCT01088048?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2010-03-25. Estimated completion is 2015-04-28.

What interventions are being tested in trial NCT01088048?

The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), Bendamustine (DRUG), Idelalisib (DRUG), Ofatumumab (DRUG).

Who is sponsoring clinical trial NCT01088048?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01088048's enrollment target sits among peer trials

241 196th of 2000 higher than 1,804 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01088048, the US trial registry maintained by the National Library of Medicine. NCT01088048 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.