Trial · NCT03151057

Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies

NCT03151057, Phase 1, Terminated, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2024-03-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies. Trials, record NCT03151057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03151057

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies
NCT number: NCT03151057
Status: Terminated
Phases: Phase 1
Enrollment: 16 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: B Cells-Tumors, B Cell Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Large B-Cell Diffuse Lymphoma of Bone (Diagnosis)
Interventions: Idelalisib 100 MG, Placebo Oral Tablet
First posted: 2017-05-12
Last updated: 2024-03-12
Results first posted: 2024-03-12

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment-limiting Toxicities Will be Defined as Idelalisib Interruption for >14 Days, or Other >3 Adverse Events as Defined by CTCAE IV Not Captured in the Protocol for Dose De-escalation.	Day 90 - Day 270 post transplant	The evaluation of the safety of Idelalisib as post-transplantation maintenance in patients with B cell hematologic malignancies
Secondary	Event Free Survival at One Year.	Beginning Day 90 post transplant until Day 360	Impact of Idelalisib on aGVHD, relapse, and non-relapse mortality
Secondary	Identify Potential Predictive Biomarker Candidates Based on Exploratory Gene Expression Analysis of Immune Biomarkers in Bone Marrow Aspirates and Whole or Targeted Exome Sequencing of Lymphoma Cells	Beginning Day 90 post transplant until Day 270	Search for Biomarkers which could better identify which patients would respond to treatment with Idelalisib in the post-transplant setting.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment-limiting Toxicities Will be Defined as Idelalisib Interruption for >14 Days, or Other >3 Adverse Events as Defined by CTCAE IV Not Captured in the Protocol for Dose De-escalation.	Day 90 - Day 270 post transplant		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event Free Survival at One Year.	Beginning Day 90 post transplant until Day 360		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Identify Potential Predictive Biomarker Candidates Based on Exploratory Gene Expression Analysis of Immune Biomarkers in Bone Marrow Aspirates and Whole or Targeted Exome Sequencing of Lymphoma Cells	Beginning Day 90 post transplant until Day 270	Exploratory gene expression analysis of immune biomarkers in bone marrow aspirates and whole or targeted exome sequencing of lymphoma cells was not was not performed on any samples for this study. This study was terminated early due to safety concerns. Samples collected were not analyzed due to an initial lack of lab staffing during COVID then were destroyed after this sponsor/investigator left Johns Hopkins.

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Treatment-limiting Toxicities Will be Defined as Idelalisib Interruption for >14 Days, or Other >3 Adverse Events as Defined by CTCAE IV Not Captured in the Protocol for Dose De-escalation.	Idelalisib 100mg	9	Participants
Treatment-limiting Toxicities Will be Defined as Idelalisib Interruption for >14 Days, or Other >3 Adverse Events as Defined by CTCAE IV Not Captured in the Protocol for Dose De-escalation.	Placebo Oral Tablet	7	Participants
Event Free Survival at One Year.	Idelalisib 100mg	9	Participants
Event Free Survival at One Year.	Placebo Oral Tablet	7	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Idelalisib 100mg	9
Overall Study	STARTED	Placebo Oral Tablet	7
Overall Study	COMPLETED	Idelalisib 100mg	9
Overall Study	COMPLETED	Placebo Oral Tablet	7
Overall Study	NOT COMPLETED	Idelalisib 100mg	0
Overall Study	NOT COMPLETED	Placebo Oral Tablet	0

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	idelalisib or placebo held for >14 days	General disorders	Idelalisib 100mg	5	9	5
other	idelalisib or placebo held for >14 days	General disorders	Placebo Oral Tablet	3	7	3
other	Graft versus host disease (GVHD)	Immune system disorders	Idelalisib 100mg	4	9	4
other	Graft versus host disease (GVHD)	Immune system disorders	Placebo Oral Tablet	2	7	2
other	Rash	Skin and subcutaneous tissue disorders	Idelalisib 100mg	3	9	3
other	Rash	Skin and subcutaneous tissue disorders	Placebo Oral Tablet	1	7	1
other	back pain	Musculoskeletal and connective tissue disorders	Idelalisib 100mg	0	9	0
other	back pain	Musculoskeletal and connective tissue disorders	Placebo Oral Tablet	1	7	1
other	headache	Nervous system disorders	Idelalisib 100mg	1	9	1
other	headache	Nervous system disorders	Placebo Oral Tablet	0	7	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Idelalisib 100mg	2	9
Total, all-cause mortality	Placebo Oral Tablet	0	7
Total, other adverse events	Idelalisib 100mg	9	9
Total, other adverse events	Placebo Oral Tablet	7	7
Total, serious adverse events	Idelalisib 100mg	7	9
Total, serious adverse events	Placebo Oral Tablet	4	7

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Idelalisib 100mg vs Placebo Oral Tablet: Event Free Survival at One Year.	Trial comparisons
Idelalisib 100mg vs Placebo Oral Tablet: deaths from any cause	Trial comparisons
Idelalisib 100mg vs Placebo Oral Tablet: Treatment-limiting Toxicities Will be Defined as Idelalisib Interruption for >14 Days, or Other >3 Adverse Events as Defined by CTCAE IV Not Captured in the Protocol for Dose De-escalation.	Trial comparisons
Idelalisib 100mg vs Placebo Oral Tablet: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03151057

GET https://conductscience.org/api/trials/v1/NCT03151057/events?page=2

API reference For AI assistants