Trial · NCT04115059

Dasatinib In Waldenström Macroglobulinemia

NCT04115059, Phase 1, Terminated, Jorge J. Castillo, MD; results first posted 2024-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dasatinib In Waldenström Macroglobulinemia. Trials, record NCT04115059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04115059

On this page

Trial

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

Title: Dasatinib In Waldenström Macroglobulinemia
NCT number: NCT04115059
Status: Terminated
Phases: Phase 1
Enrollment: 3 participants, actual
Lead sponsor: Jorge J. Castillo, MD
Conditions: Waldenstrom Macroglobulinemia, DASATINIB
Interventions: Dasatinib
First posted: 2019-10-03
Last updated: 2024-03-21
Results first posted: 2024-03-21

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Number of Participants With at Least One Treatment-Emergent Adverse Event	2 years	Count of participants who experience a treatment-emergent adverse event
Secondary	Overall Response Rate	2 years	Percentage of patients with an Overall Response. Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).
Secondary	Complete Response Rate	2 years	Percentage of patients with Complete Response (CR). Complete Response requires resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, and resolution of any adenopathy or splenomegaly.
Secondary	Very Good Partial Response Rate	2 years	Percentage of patients with very good partial response (VGPR) to therapy. (VGPR is \>90% reduction in serum IgM from baseline)
Secondary	Partial Response Rate	2 years	Percentage of patients with partial response (PR) to therapy. (PR is 50-89% reduction in serum IgM from baseline)
Secondary	Minimal Response Rate	2 years	Percentage of patients with Minor Responses to therapy. (MR is 25-49% reduction in serum IgM from baseline)
Secondary	Stable Disease Rate	2 years	Percentage of patients with Stable disease to therapy. (SD is \<25% reduction in serum IgM from baseline).
Secondary	Progressive Disease Rate	From first dose through disease progression, up to 2 years from baseline	Percentage of patients with who experienced disease progression on study. PD is \>25% increase in serum IgM from baseline with an absolute increase of at least 500 mg/dL, or progression of clinically significant disease related symptoms. Death from any cause or initiation of a new anti-neoplastic therapy will also be considered a progression event. An increase of 1 cm in any axis for adenopathy, or 2 cm in the craniocaudal axis of the spleen will be considered evidence of progression of extramedullary disease. Development of Bing Neel syndrome, or other extramedullary disease manifestations, as well as disease transformation will be considered as progressive events.
Secondary	Progression Free Survival	From first dose through disease progression, up to 2 years from baseline	The amount of time between starting treatment and experiencing disease progression. PD is \>25% increase in serum IgM from baseline with an absolute increase of at least 500 mg/dL, or progression of clinically significant disease related symptoms. Death from any cause or initiation of a new anti-neoplastic therapy will also be considered a progression event. An increase of 1 cm in any axis for adenopathy, or 2 cm in the craniocaudal axis of the spleen will be considered evidence of progression of extramedullary disease. Development of Bing Neel syndrome, or other extramedullary disease manifestations, as well as disease transformation will be considered as progressive events.
Secondary	Time to Next Therapy (TTNT)	From first dose through initiation of new therapy, up to 2 years from baseline	The amount of time between starting study treatment and initiating a new therapy

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With at Least One Treatment-Emergent Adverse Event	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Response Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Complete Response Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Very Good Partial Response Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Partial Response Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Minimal Response Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Stable Disease Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progressive Disease Rate	From first dose through disease progression, up to 2 years from baseline	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	From first dose through disease progression, up to 2 years from baseline	months	MEDIAN
SECONDARY	Time to Next Therapy (TTNT)	From first dose through initiation of new therapy, up to 2 years from baseline	months	MEDIAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group11

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

Outcome	Group	Value	Spread	Units
Number of Participants With at Least One Treatment-Emergent Adverse Event	Dasatinib	3		Participants
Overall Response Rate	Dasatinib	0		Participants
Complete Response Rate	Dasatinib	0		Participants
Very Good Partial Response Rate	Dasatinib	0		Participants
Partial Response Rate	Dasatinib	0		Participants
Minimal Response Rate	Dasatinib	0		Participants
Stable Disease Rate	Dasatinib	3		Participants
Progressive Disease Rate	Dasatinib	2		Participants
Progression Free Survival	Dasatinib	5	Full Range 0 to 5	months
Time to Next Therapy (TTNT)	Dasatinib	6	Full Range 1 to 6	months

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dasatinib	3
Overall Study	COMPLETED	Dasatinib	0
Overall Study	NOT COMPLETED	Dasatinib	3

Source ClinicalTrials.gov

Adverse events26

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	Anemia	Blood and lymphatic system disorders	Dasatinib	2	3	2
other	Congestive heart failure	Cardiac disorders	Dasatinib	1	3	1
other	Heart failure	Cardiac disorders	Dasatinib	1	3	1
other	Abdominal distention	Gastrointestinal disorders	Dasatinib	1	3	1
other	Constipation	Gastrointestinal disorders	Dasatinib	1	3	1
other	Diarrhea	Gastrointestinal disorders	Dasatinib	1	3	1
other	Mouth sores	Gastrointestinal disorders	Dasatinib	1	3	1
other	Edema	General disorders	Dasatinib	1	3	1
other	Fatigue	General disorders	Dasatinib	2	3	2
other	Fever	General disorders	Dasatinib	2	3	2

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dasatinib	1	3
Total, other adverse events	Dasatinib	3	3
Total, serious adverse events	Dasatinib	2	3

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36051045	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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/NCT04115059

GET https://conductscience.org/api/trials/v1/NCT04115059/events?page=2

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