All > Myelofibrosis > Polycythemia Vera

Elotuzumab for Primary Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TXPrimary Myelofibrosis+2 MoreElotuzumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a drug to see if it can help treat myelofibrosis, a disease which causes problems with blood cell production.

Eligible Conditions
  • Primary Myelofibrosis
  • Essential Thrombocythemia Myelofibrosis Transformation
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Imetelstat
1
Ipilimumab
1
Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide)

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 5 years

Year 5
JAK2V617F allele burden in the bone marrow or blood
Percentage of circulating SLAMF7high/CD16neg monocytes
Serum IL-1Ralpha levels
Year 5
Bone Marrow
Day 30
Incidence of adverse events
Up to 5 years
Biomarker analysis
Duration of response
Bone Marrow
Platelet response rate
Rates of clinical improvement
Rates of complete response
Rates of partial response
Therapeutic procedure
Day 28
Overall response (OR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Imetelstat
1
Ipilimumab
1
Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide)

Side Effects for

E-Ld
54%Fatigue
37%Diarrhoea
34%Upper respiratory tract infection
31%Insomnia
29%Constipation
29%Muscle spasms
27%Nausea
24%Oedema peripheral
24%Urinary tract infection
24%Back pain
23%Anaemia
23%Dyspnoea
21%Pyrexia
21%Arthralgia
21%Cough
20%Pruritus
19%Neutropenia
19%Rash
19%Headache
19%Dizziness
17%Asthenia
16%Hypokalaemia
16%Neuropathy peripheral
16%Anxiety
14%Nasopharyngitis
14%Abdominal pain
14%Decreased appetite
13%Gastrooesophageal reflux disease
13%Dehydration
13%Hyperhidrosis
11%Muscular weakness
11%Vomiting
11%Thrombocytopenia
11%Vision blurred
11%Fall
11%Hyperglycaemia
10%Chills
10%Musculoskeletal pain
10%Vitamin d decreased
10%Pain in extremity
10%Myalgia
10%Dysgeusia
10%Night sweats
9%Atrial fibrillation
9%Epistaxis
9%Dysphonia
9%Hypotension
7%Hypoaesthesia
7%Pneumonia
7%Hypocalcaemia
7%Dry mouth
7%Sinusitis
7%Blood creatinine increased
7%Non-cardiac chest pain
7%Musculoskeletal chest pain
7%Dysuria
7%Oropharyngeal pain
7%Hot flush
6%Dry eye
6%Pain
6%Influenza
6%Weight decreased
6%Influenza like illness
6%Neck pain
6%Malaise
6%Squamous cell carcinoma
6%Peripheral sensory neuropathy
6%Balance disorder
6%Syncope
6%Hypertension
6%Tremor
6%Hiccups
6%Haematuria
6%Rash maculo-papular
6%Productive cough
3%Bronchitis
3%Spinal cord compression
3%Femur fracture
3%Hypoglycaemia
3%Pulmonary embolism
3%Acute kidney injury
3%Acute respiratory failure
3%Pulmonary oedema
1%Acidosis
1%Visual impairment
1%Delirium
1%Thrombotic thrombocytopenic purpura
1%Clostridium difficile colitis
1%Clostridium difficile infection
1%Atrial flutter
1%Cardio-respiratory arrest
1%Gastroenteritis
1%Female genital tract fistula
1%Colitis ischaemic
1%Diverticular perforation
1%Cavernous sinus thrombosis
1%Haematochezia
1%Cholecystitis acute
1%Urosepsis
1%Septic shock
1%Bone pain
1%Acute psychosis
1%Malignant neoplasm progression
1%Renal failure
1%Chronic obstructive pulmonary disease
1%Subdural haematoma
1%Deep vein thrombosis
1%Hypoxia
1%Interstitial lung disease
1%Respiratory failure
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02159365) in the E-Ld ARM group. Side effects include: Fatigue with 54%, Diarrhoea with 37%, Upper respiratory tract infection with 34%, Insomnia with 31%, Constipation with 29%.

Trial Design

1 Treatment Group

Treatment (elotuzumab)
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Elotuzumab · No Placebo Group · Phase 2

Treatment (elotuzumab)Experimental Group · 2 Interventions: Questionnaire Administration, Elotuzumab · Intervention Types: Other, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,824 Previous Clinical Trials
1,792,523 Total Patients Enrolled
24 Trials studying Primary Myelofibrosis
855 Patients Enrolled for Primary Myelofibrosis
Prithviraj BosePrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
140 Total Patients Enrolled
2 Trials studying Primary Myelofibrosis
71 Patients Enrolled for Primary Myelofibrosis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your doctor has determined that you cannot receive JAK inhibitor therapy.
References

Frequently Asked Questions

What is the scope of this clinical experiment in terms of participant numbers?

"Yes, clinicaltrials.gov evidences that this research is actively recruiting volunteers for a trial which was first made public on February 10th 2021 and most recently updated in November 11th 2022. The study requires 15 participants from 1 medical centre." - Anonymous Online Contributor

Unverified Answer

Is there capacity for more volunteers at this trial?

"According to the entry on clinicaltrials.gov, this medical trial is open to participants and has seen recent updates since its initiation back in February 2021. The most recent changes were posted on November 2022." - Anonymous Online Contributor

Unverified Answer

Has Elotuzumab been tested in other laboratory settings?

"Currently, there are 23 clinical trials being conducted with elotuzumab. Of these studies, 3 have reached phase III and 857 sites around the world are involved in their execution. The majority of locations for this research are located within Houston, Texas." - Anonymous Online Contributor

Unverified Answer

Could you provide an overview of Elotuzumab's safety profile?

"Elotuzumab's safety rating on a scale from 1-3 is 2 as this phase 2 trial has generated data supporting its security, yet efficacy remains unproven." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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