Trial · NCT02677324

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia

NCT02677324, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2021-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia. Trials, record NCT02677324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02677324

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Trial

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

Title: Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia
NCT number: NCT02677324
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Waldenstrom Macroglobulinemia
Interventions: ABT199
First posted: 2016-02-09
Last updated: 2022-05-11
Results first posted: 2021-05-11

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	2 years	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	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	2 years	Number of participants who experienced an adverse event while on ABT-199
Secondary	Number of Participants With Complete Response	2 years	A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.
Secondary	Number of Participants With Very Good Partial Response	2 years	Very Good Partial Response (VGPR): is defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels.
Secondary	Number of Participants With Partial Response	2 years	Partial response (PR) is defined as achieving a ≥50% reduction in serum IgM levels.
Secondary	Number of Participants With Minor Response	2 years	Minor Response (MR): A minor response (MR) is defined 25-49% reduction in serum IgM levels.
Secondary	Number of Participants With Stable Disease	2 years	Stable disease is defined as having \<25% increase in serum IgM levels and \<25% reduction in serum IgM levels
Secondary	Progression Free Survival	4 years	Amount of time following ABT-199 administration until \>25% increase in serum IgM
Secondary	Overall Response Rate Among CXCR4 Mutated Participants	2 years	Overall Response Rate for participants who tested positive for a CXCR4 mutation= 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	Overall Response Rate Among Participants Without CXCR4 Mutations	2 years	Overall Response Rate in participants who tested negative for a CXCR4 mutation= 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).

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate	2 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Complete Response	2 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Very Good Partial Response	2 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Partial Response	2 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Minor Response	2 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Stable Disease	2 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	4 years	1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.	months	MEDIAN
SECONDARY	Overall Response Rate Among CXCR4 Mutated Participants	2 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Response Rate Among Participants Without CXCR4 Mutations	2 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Overall Response Rate	ABT199	26		Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	ABT199	33		Participants
Number of Participants With Complete Response	ABT199	0		Participants
Number of Participants With Very Good Partial Response	ABT199	6		Participants
Number of Participants With Partial Response	ABT199	19		Participants
Number of Participants With Minor Response	ABT199	1		Participants
Number of Participants With Stable Disease	ABT199	2		Participants
Progression Free Survival	ABT199	31.5	95% Confidence Interval 26.6 to 38.6	months
Overall Response Rate Among CXCR4 Mutated Participants	CXCR4 Mutated Participants	14		Participants
Overall Response Rate Among Participants Without CXCR4 Mutations	CXCR4 Wild-Type Participants	13		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ABT199	33
Overall Study	COMPLETED	ABT199	21
Overall Study	NOT COMPLETED	ABT199	12

Source ClinicalTrials.gov

Adverse events92

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	Fatigue	General disorders	ABT199	23	33	23
other	Fever	General disorders	ABT199	8	33	8
other	Pain	General disorders	ABT199	6	33	6
other	Edema limbs	General disorders	ABT199	5	33	5
other	Myalgia	Musculoskeletal and connective tissue disorders	ABT199	9	33	9
other	Non-cardiac chest pain	General disorders	ABT199	4	33	4
other	Chills	General disorders	ABT199	3	33	3
other	Dizziness	General disorders	ABT199	2	33	2
other	Hyperhidrosis	Skin and subcutaneous tissue disorders	ABT199	11	33	11
other	Upper respiratory infection	Infections and infestations	ABT199	15	33	15

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ABT199	0	33
Total, other adverse events	ABT199	33	33
Total, serious adverse events	ABT199	13	33

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34793256	DERIVED	PubMed
40674749	DERIVED	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/NCT02677324

GET https://conductscience.org/api/trials/v1/NCT02677324/events?page=2

API reference For AI assistants