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Vascular Disrupting Agent

BNC105P for Chronic Lymphocytic Leukemia

Q: Are fresh enrollees still being accepted for this experiment?

Unfortunately, this clinical trial is not seeking new participants at the moment. According to records which were last updated on August 9th 2022, it was originally posted on March 9th 2018. However, there are still 346 studies related to <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and lymphocytic chronic b-cell actively looking for volunteers as well as 155 trials centered around BNC105P that need recruits.

Q: Are the regulatory bodies sanctioning BNC105P?

BNC105P has been assigned a 1 on our safety scale, as there is only limited evidence to support its efficacy and protection.

Q: To what extent does this research encompass participants?

This trial is no longer accepting new participants, as the last update was made in August 2022. For those seeking alternative studies, 346 trials are currently taking on patients with <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and lymphocytic chronic B-cell conditions; additionally, 155 separate clinical trials are enrolling individuals for BNC105P treatment.

Phase 1

Waitlist Available

Led By Lionel D Lewis, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial is testing the combination of two drugs, ibrutinib and BNC105P, to see if it is more effective than ibrutinib alone in treating chronic lymphocytic leukemia. The study will also establish the maximum tolerated dose of the combination and assess its efficacy.

Eligible Conditions

Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To establish the maximum tolerated dose and toxicity of BNC105P plus Ibrutinib

Secondary outcome measures

Determine the Overall Response Rate (ORR)

Determine the event free survival

Chronic Lymphocytic Leukemia

Other outcome measures

Explore the effects of BNC105P and BNC105P + Ibrutinib on NOXA and JNK in Chronic Lymphocytic Leukemia Cells

Side effects data

From 2016 Phase 1 & 2 trial • 154 Patients • NCT01034631

80%

FATIGUE (ASTHENIA, LETHARGY, MALAISE)

73%

HEMOGLOBIN

60%

HYPERTENSION

60%

NAUSEA

53%

CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)

47%

PAIN

47%

PAIN / CHEST WALL

47%

MUSCULOSKELETAL/SOFT TISSUE

47%

PLATELETS

47%

DIARRHEA

47%

COUGH

47%

WEIGHT LOSS

40%

PAIN / BACK

40%

TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA)

40%

CONSTIPATION

33%

PLEURAL EFFUSION (NON-MALIGNANT)

33%

ALKALINE PHOSPHATASE

33%

FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)

33%

VOMITING

33%

CREATININE

33%

SODIUM, SERUM-LOW (HYPONATREMIA)

27%

PAIN / ABDOMEN NOS

27%

ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)

27%

ALLERGY/IMMUNOLOGY

27%

HEARTBURN/DYSPEPSIA

27%

OCULAR/VISUAL

27%

EDEMA: LIMB

27%

ANOREXIA

27%

DRY SKIN

27%

PAIN / EXTREMITY-LIMB

27%

PERICARDIAL EFFUSION (NON-MALIGNANT)

27%

PROTEINURIA

20%

PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)

20%

PRURITUS/ITCHING

20%

METABOLIC/LABORATORY

20%

PULMONARY/UPPER RESPIRATORY

20%

PAIN / JOINT

20%

LEUKOCYTES (TOTAL WBC)

20%

TASTE ALTERATION (DYSGEUSIA)

20%

PAIN / HEAD/HEADACHE

20%

SWEATING (DIAPHORESIS)

20%

DYSPNEA (SHORTNESS OF BREATH)

20%

RENAL FAILURE

20%

DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)

20%

GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)

20%

MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY

20%

GASTROINTESTINAL

20%

RENAL/GENITOURINARY

20%

RIGORS/CHILLS

20%

THYROID FUNCTION, LOW (HYPOTHYROIDISM)

13%

AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)

13%

HYPOXIA

13%

LYMPHOPENIA

13%

RASH: ACNE/ACNEIFORM

13%

PNEUMONITIS/PULMONARY INFILTRATES

13%

POTASSIUM, SERUM-LOW (HYPOKALEMIA)

13%

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)

13%

ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)

13%

INFECTION

13%

INFECTION WITH UNKNOWN ANC / URINARY TRACT NOS

13%

DEHYDRATION

13%

HYPERPIGMENTATION

13%

PAIN / CHEST/THORAX NOS

13%

NASAL CAVITY/PARANASAL SINUS REACTIONS

13%

PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE

13%

MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED

13%

NAIL CHANGES

13%

PAIN / MUSCLE

13%

POTASSIUM, SERUM-HIGH (HYPERKALEMIA)

13%

MOOD ALTERATION / ANXIETY

13%

PAIN / BONE

13%

AUDITORY/EAR

13%

CALCIUM, SERUM-HIGH (HYPERCALCEMIA)

13%

CONSTITUTIONAL SYMPTOMS

13%

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS

13%

INSOMNIA

13%

CONFUSION

13%

VISION-BLURRED VISION

PTT (PARTIAL THROMBOPLASTIN TIME)

DENTAL: TEETH

HOT FLASHES/FLUSHES

MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)

FLATULENCE

INFECTION WITH UNKNOWN ANC / SINUS

MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)

RASH/DESQUAMATION

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS

BLOOD/BONE MARROW

BILIRUBIN (HYPERBILIRUBINEMIA)

INCONTINENCE, ANAL

CALCIUM, SERUM-LOW (HYPOCALCEMIA)

ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UNGUAL (NAILS)

DIZZINESS

HAIR LOSS/ALOPECIA (SCALP OR BODY)

ENDOCRINE

LEFT VENTRICULAR SYSTOLIC DYSFUNCTION

LIVER DYSFUNCTION/FAILURE (CLINICAL)

PAIN / THROAT/PHARYNX/LARYNX

SODIUM, SERUM-HIGH (HYPERNATREMIA)

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)

PAIN / STOMACH

THROMBOSIS/THROMBUS/EMBOLISM

SEROMA

OSTEOPOROSIS

PAIN / ORAL CAVITY

ULCER, GI / DUODENUM

VASCULAR

THYROID FUNCTION, HIGH (HYPERTHYROIDISM, THYROTOXICOSIS)

ARTHRITIS (NON-SEPTIC)

HEMORRHOIDS

URTICARIA (HIVES, WELTS, WHEALS)

ACIDOSIS (METABOLIC OR RESPIRATORY)

BICARBONATE, SERUM-LOW

CARDIAC GENERAL

CERVICAL SPINE-RANGE OF MOTION

DERMATOLOGY/SKIN

EDEMA: HEAD AND NECK

GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)

HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SINUS

MOOD ALTERATION / DEPRESSION

NEUROENDOCRINE: ADH SECRETION ABNORMALITY (E.G., SIADH OR LOW ADH)

NEUROLOGY

NEUTROPHILS/GRANULOCYTES (ANC/AGC)

ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)

ASCITES (NON-MALIGNANT)

INCONTINENCE, URINARY

URINE COLOR CHANGE

INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / SKIN (CELLULITES)

INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ORAL CAVITY-GUMS (GINGIVITIS)

MEMORY IMPAIRMENT

MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY

PAIN / BREAST

SEIZURE

SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION

100%

80%

60%

40%

20%

Study treatment Arm

Phase I Participants

Phase II: Arm B Participants

Phase II: Arm A

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment2 Interventions

Evaluate the MTD of BNC105P in combination with ibrutinib in patients with relapsed/refractory CLL. Treatment will be administered on an outpatient basis but will also be permitted inpatient. BNC105P will be administered as a single agent prior to initiation of ibrutinib. Beginning with cycle 2, ibrutinib will be administered concomitantly with BNC105P at a starting dose of 420 mg PO daily. Each cycle will last for 21 days. Provided no toxicities occur, each patient will be treated for 6 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BNC105P

2010

Completed Phase 2

~160

Ibrutinib

2014

Completed Phase 3

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,543,335 Total Patients Enrolled

Lionel D Lewis, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

2 Previous Clinical Trials

37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are fresh enrollees still being accepted for this experiment?

"Unfortunately, this clinical trial is not seeking new participants at the moment. According to records which were last updated on August 9th 2022, it was originally posted on March 9th 2018. However, there are still 346 studies related to leukemia and lymphocytic chronic b-cell actively looking for volunteers as well as 155 trials centered around BNC105P that need recruits."

Answered by AI

Are the regulatory bodies sanctioning BNC105P?

"BNC105P has been assigned a 1 on our safety scale, as there is only limited evidence to support its efficacy and protection."

Answered by AI

To what extent does this research encompass participants?

"This trial is no longer accepting new participants, as the last update was made in August 2022. For those seeking alternative studies, 346 trials are currently taking on patients with leukemia and lymphocytic chronic B-cell conditions; additionally, 155 separate clinical trials are enrolling individuals for BNC105P treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BNC105P Combined With Ibrutinib

Lionel.D.Lewis, MD 2018. "A Study of BNC105P Combined With Ibrutinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03454165.