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Monoclonal Antibodies
Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Phase 2
Waitlist Available
Led By Gautam Borthakur
Research Sponsored by M.D. Anderson Cancer 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 up to 3.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well daratumumab and venetoclax work in treating patients with certain types of leukemia and myelodysplastic syndrome that are hard to treat or have returned. The treatment boosts the immune system to attack cancer cells and prevents them from surviving. Daratumumab has been used in the treatment of multiple myeloma and has shown efficacy in relapsed or refractory cases.
Eligible Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Acute Myelogenous Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Participants With a Response
Secondary study objectives
Overall Survival
Progression Free Survival
Time on Treatment
Other study objectives
Biomarkers predictive of response or resistance to therapy
Side effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613444%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Insomnia
15%
Asthenia
13%
Cough
11%
Nausea
11%
Pyrexia
11%
Dizziness
11%
Neuralgia
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Headache
6%
Paraesthesia
6%
Bronchitis
6%
Arthralgia
5%
Bone pain
5%
Bone Pain
5%
Decreased Appetite
5%
Hypocalcaemia
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
5%
Epistaxis
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Abdominal pain
4%
Alanine aminotransferase increased
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Rash
3%
Hypertension
3%
Abdominal Pain Upper
3%
Abdominal pain upper
3%
Hypophosphataemia
3%
Influenza
3%
Conjunctivitis
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Urinary tract infection
2%
Herpes Zoster
1%
Weight decreased
1%
Pulmonary Embolism
1%
Pulmonary embolism
1%
Nasal congestion
1%
Weight Decreased
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Sepsis
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Syncope
1%
Productive cough
1%
Lower respiratory tract infection
1%
Respiratory failure
1%
Chills
1%
Gastroenteritis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (daratumumab)Experimental Treatment1 Intervention
Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2380
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,801 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,181 Total Patients Enrolled
Gautam BorthakurPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
426 Total Patients Enrolled