NCT04115059 · REGISTRY CONDITION SEARCH

Dasatinib In Waldenström Macroglobulinemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: TERMINATED
Registry last update: 2024-03-21

This is Phase I pilot, single center study designed to explore the safety of Dasatinib in symptomatic Waldenström Macroglobulinemia participants who are progressing on ibrutinib therapy with BTK Cys481 or PLCG2 mutations

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With at Least One Treatment-Emergent Adverse Event

→

outcome · POSTED

Overall Response Rate

→

outcome · POSTED

Complete Response Rate

→

outcome · POSTED

Very Good Partial Response Rate

→

outcome · POSTED

Partial Response Rate

→

outcome · POSTED

Minimal Response Rate

→

outcome · POSTED

Stable Disease Rate

→

outcome · POSTED

Progressive Disease Rate

→

outcome · POSTED

Progression Free Survival

→

outcome · POSTED

Time to Next Therapy (TTNT)

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Participants must meet the following criteria on screening examination to be eligible to participate. Screening evaluations including consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1. Bone marrow biopsy \& aspirate, and CT C/A/P will be done within 90 days prior to Cycle 1 Day 1. * Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia * Known tumor expression of mutated MYD88 performed by a CLIA certified laboratory. * Participants must have a BTKCys481 and/or PLCγ2 mutation. Genomic alterations must be confirmed via sequencing performed at NeoGenomics Laboratories * At least one previous therapy, with ibrutinib as the most recent treatment. Participants may remain on ibrutinib therapy during screening. A 1 day washout before starting dasatinib is required. * Documented disease progression on last regimen (ibrutinib) per the Sixth International Workshop on WM. One or more of the following: * 25% increase in serum IgM level with at least 500 mg/dL absolute increase from nadir with re-confirmation * Progression of clinically significant disease related symptoms * Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on WM \[26\]. One or more of the following: * Constitutional symptoms * Progressive or symptomatic lymphadenopathy or splenomegaly * Hemoglobin \<10 g/dL * Platelet count \<100 k/uL * Symptomatic peripheral neuropathy * Systemic amyloidosis * Renal insufficiency * Symptomatic cryoglobulinemia * Age 18 years or older * Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum serum IgM level of \> 2 times the upper limit normal. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) * Women of childbearing potential: Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 28 days after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed. * Men must agree to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy. * Participants must have normal organ and marrow function as defined below: * Absolute neutrophil count ≥500/ uL (Growth factor not permitted) * Platelets ≥50,000/ uL (Platelet transfusion not permitted) * Hemoglobin ≥ 7 g/dL (RBC transfusion permitted) * Total bilirubin ≤ 2 mg/dL * Potassium ≥ LLN * Magnesium ≥ LLN * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal * Estimated GFR ≥ 30 ml/min * Able to swallow pills. * Able to adhere to the study visit schedule and other protocol requirements. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study: * Lactating or pregnant women. * Participants who are receiving any other investigational agents. * Prior therapy with BCR-ABL inhibitors. * Known CNS lymphoma. * Symptomatic hyperviscosity requiring urgent therapy. * Human Immunodeficiency Virus (HIV), active infection with Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pleural or pericardial effusion, unstable angina pectoris, cardiac arrhythmia, QT Prolongation, or psychiatric illness/social situations that would limit compliance with study requirements. * Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec) * History clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes * Known history of alcohol or drug abuse * On any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skin. * History of non-compliance to medical regimens. * Treatment with strong CYP3A4/5 inhibitors or inducers * Participants who are taking St. Johns Wort. Must discontinue at least 5 days before starting dasatinib. * Treatment with H2 Antagonists and proton pump inhibitors
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
\-- After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. Dasatinib: Oral Study Drug(s): * Each study treatment cycle lasts 4 weeks during which time you will be taking the study drug one time per day. * This will continue for up to 24 cycles.
intervention Names
Drug: Dasatinib
label
Dasatinib
type
EXPERIMENTAL

interventions

arm Group Labels
Dasatinib
description
Oral, daily, dosing per protocol, once a day for cycle
name
Dasatinib
other Names
Sprycel
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Count of participants who experience a treatment-emergent adverse event
measure
Number of Participants With at Least One Treatment-Emergent Adverse Event
time Frame
2 years

secondary Outcomes

description
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).
measure
Overall Response Rate
time Frame
2 years
description
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.
measure
Complete Response Rate
time Frame
2 years
description
Percentage of patients with very good partial response (VGPR) to therapy. (VGPR is \>90% reduction in serum IgM from baseline)
measure
Very Good Partial Response Rate
time Frame
2 years
description
Percentage of patients with partial response (PR) to therapy. (PR is 50-89% reduction in serum IgM from baseline)
measure
Partial Response Rate
time Frame
2 years
description
Percentage of patients with Minor Responses to therapy. (MR is 25-49% reduction in serum IgM from baseline)
measure
Minimal Response Rate
time Frame
2 years
description
Percentage of patients with Stable disease to therapy. (SD is \<25% reduction in serum IgM from baseline).
measure
Stable Disease Rate
time Frame
2 years
description
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.
measure
Progressive Disease Rate
time Frame
From first dose through disease progression, up to 2 years from baseline
description
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.
measure
Progression Free Survival
time Frame
From first dose through disease progression, up to 2 years from baseline
description
The amount of time between starting study treatment and initiating a new therapy
measure
Time to Next Therapy (TTNT)
time Frame
From first dose through initiation of new therapy, up to 2 years from baseline
description
The number of participants who are still alive at the end of follow-up. Participants were observed for up to 2 years after discontinuing study therapy for survival status.
measure
Overall Survival
time Frame
From first dose through death, up to 2 years from baseline

Full study description

brief Summary: This is Phase I pilot, single center study designed to explore the safety of Dasatinib in symptomatic Waldenström Macroglobulinemia participants who are progressing on ibrutinib therapy with BTK Cys481 or PLCG2 mutations
detailed Description: This research study is a Pilot Study, which is the first time investigators are examining this drug in patients with Waldenström Macroglobulinemia who have progressed on ibrutinib. Patients who fulfill eligibility criteria will be entered into the trial to receive Dasatinib After the screening procedures confirm participation in the research study: The participant will be given a study drug-dosing calendar for each treatment cycle. In this research study, the investigators are planning to give Dasatinib, which is a targeted therapy intended to treat cancer by binding to the target protein called BTK. * BTK is believed to be an important target for treatment of patients with specific gene mutations. Some patients who have disease progression after taking ibrutinib have these gene mutations. * Making treatment decisions based on genetic testing is investigational, and the FDA has not approved this genetic testing. The U.S. Food and Drug Administration (FDA) has not approved Dasatinib for Waldenström Macroglobulinemia but it has been approved for other uses. Dasatinib is produced by Bristol-Myers Squibb.

Source references

references

citation
Castillo JJ, Sarosiek S, Flynn CA, Leventoff C, Little M, White T, Meid K, Treon SP. A pilot study on dasatinib in patients with Waldenstrom macroglobulinemia progressing on ibrutinib. EJHaem. 2022 Jun 7;3(3):927-929. doi: 10.1002/jha2.493. eCollection 2022 Aug.
pmid
36051045
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-1b06b3713ffb62e71b1c
requested nct id
NCT04115059
primary nct id
NCT04115059
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
70f69ad8e0f30ff1fa740119525dd216f20ed4809e020f714bad7f2ecfd73fa1
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-1b06b3713ffb62e71b1c
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT04115059
occurrences
context exact
NCT04115059
end
11
exact text
NCT04115059
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/483/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
ea4587db74e08e990b490805ff02bb79fd30613fd40f67cecb0107eabf357a4e
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice