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Targeted Immunotherapy for Leukemia (ALLO-T-DART Trial)
Phase 1
Recruiting
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy
Performance status ≥ 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
ALLO-T-DART Trial Summary
This trial will test if a targeted immunotherapy drug is safe for kids with T-cell leukemia/lymphoma after a bone marrow transplant. It will look at how the drug affects their recovery.
Who is the study for?
This trial is for children, adolescents, and young adults (0-39 years old) with high-risk T-cell acute lymphoblastic leukemia or lymphoma in remission or complete response after therapy. They must be planning a stem cell transplant, have good performance status, recovered from previous treatments' effects, meet organ function criteria, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests the safety of daratumumab immunotherapy following total body irradiation and stem cell transplantation in patients with T-cell leukemia/lymphoma. It will also study how this treatment affects disease markers and immune system recovery to see if there's a link to patient outcomes.See study design
What are the potential side effects?
Daratumumab may cause infusion reactions like coughing or difficulty breathing; fatigue; nausea; fever; chills; bone pain. It can also affect blood counts leading to increased risk of infections or bleeding.
ALLO-T-DART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My T-cell acute lymphoblastic leukemia is in remission or responded well after more treatment.
Select...
I can do most of my daily activities without help.
Select...
I am scheduled for a stem cell transplant with a donor already found.
Select...
I am between 0 and 39 years old.
ALLO-T-DART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patients with dose limiting toxicity (per CTCAE v.5)
Secondary outcome measures
Relapse free survival
Side effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Febrile neutropenia
1%
Squamous cell carcinoma of skin
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
ALLO-T-DART Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
Phase 1: 3 dose levels to determine safety (15 patients)
Dose expansion:
Daratumumab (DARA) treatment post-HCT
Induction: DARA IV weekly x 8 doses (Weeks 1-8)
Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)
Maintenance: DARA IV every 4 weeks (Stop at Day +270)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Find a Location
Who is running the clinical trial?
New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,031 Total Patients Enrolled
Troy Quigg, DOStudy ChairHelen DeVos Children's Hospital
1 Previous Clinical Trials
95 Total Patients Enrolled
Allyson Flower, MDStudy ChairMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have asthma.My T-cell acute lymphoblastic leukemia is in remission or responded well after more treatment.I have not had a stem cell transplant before.I can do most of my daily activities without help.My organs are functioning well.I have COPD.I am scheduled for a stem cell transplant with a donor already found.I am between 0 and 39 years old.I have no lingering side effects from previous cancer treatments.I do not have an untreated or uncontrolled infection.I am not allergic to mannitol, sorbitol, corticosteroids, monoclonal antibodies, human proteins, or their excipients.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on the most common applications for Daratumumab?
"Daratumumab is a biological response modifier, typically utilized to treat refractory multiple myeloma, relapsed or refractory multiple myeloma, and cell transplants."
Answered by AI
How many participants are enrolling in this clinical trial?
"Affirmative, clinicaltrials.gov's data verifies that this medical trial is actively searching for participants. The investigation was first posted on May 22nd 2023 and the latest update to the study occured June 29th 2023. 30 patients are needed at a single site for enrollment."
Answered by AI
Is there still an opportunity for individuals to participate in this research endeavor?
"Indeed, the clinicaltrials.gov repository attests to this trial's recruitment process being ongoing. Initially posted on 22nd May 2023 and last modified on 29th June 2023, it is seeking 30 participants at one medical facility."
Answered by AI
Has Daratumumab attained authorization from the FDA?
"Due to its Phase 1 classification, our team at Power has assigned a score of 1 out of 3 for Daratumumab's safety profile. This denotes there is limited data concerning the efficacy and security of this medication."
Answered by AI
Has Daratumumab been studied in any other research initiatives?
"Currently, 124 clinical trials are in progress for Daratumumab with 24 of those located at the third phase. The primary research hub is Basking Ridge, New jersey although there exist 5783 sites studying this medication across the nation."
Answered by AI
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