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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%
Must not have
COPD
Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My T-cell acute lymphoblastic leukemia is in remission or responded well after more treatment.
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I can do most of my daily activities without help.
Select...
I am scheduled for a stem cell transplant with a donor already found.
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I am between 0 and 39 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have COPD.
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I am not allergic to mannitol, sorbitol, corticosteroids, monoclonal antibodies, human proteins, or their excipients.
Select...
I have a serious heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 • NCT02136134
60%
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%
Oedema peripheral
20%
Arthralgia
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%
Bone pain
9%
Leukopenia
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%
Hypocalcaemia
7%
Herpes zoster
7%
Influenza
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Abdominal pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
5%
Throat irritation
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Pathological fracture
1%
Femur fracture
1%
Pleural effusion
1%
Lower Respiratory Tract Infection
1%
Angina unstable
1%
Pulmonary sepsis
1%
Hypercalcaemia
1%
Acute myocardial infarction
1%
Hip fracture
1%
Pulmonary Sepsis
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Ischaemic stroke
1%
Rib fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Cerebrovascular accident
1%
Febrile neutropenia
1%
Lower respiratory tract infection
1%
Humerus fracture
1%
Squamous cell carcinoma of skin
1%
Pneumonia cytomegaloviral
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

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
70 Previous Clinical Trials
6,103 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

Interventional Clinical Trial Eligibility Overview. Trial Name: NCT04972942 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Interventional
Acute Lymphoblastic Leukemia Clinical Trial 2023: Interventional Highlights & Side Effects. Trial Name: NCT04972942 — Phase 1
Interventional 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972942 — Phase 1
~20 spots leftby Sep 2027
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