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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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

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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:

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I have COPD.

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I am not allergic to mannitol, sorbitol, corticosteroids, monoclonal antibodies, human proteins, or their excipients.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patients with dose limiting toxicity (per CTCAE v.5)

Secondary study objectives

Relapse free survival

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

44%

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%

Neuralgia

11%

Pyrexia

11%

Dizziness

10%

Back pain

10%

Back Pain

10%

Pneumonia

10%

Neutropenia

Dyspnoea

Oedema peripheral

Oedema Peripheral

Pain in extremity

Hyperglycaemia

Pain in Extremity

Arthralgia

Headache

Paraesthesia

Bronchitis

Bone pain

Epistaxis

Bone Pain

Decreased Appetite

Hypocalcaemia

Dyspepsia

Leukopenia

Hypokalaemia

Decreased appetite

Lymphopenia

Oedema

Vomiting

Hypotension

Alanine aminotransferase increased

Abdominal pain

Nasopharyngitis

Alanine Aminotransferase Increased

Hypertension

Rash

Abdominal Pain Upper

Conjunctivitis

Hypophosphataemia

Abdominal pain upper

Influenza

Muscle Spasms

Musculoskeletal Chest Pain

Aspartate aminotransferase increased

Muscle spasms

Urinary tract infection

Myalgia

Herpes zoster

Musculoskeletal chest pain

Herpes Zoster

Pulmonary Embolism

Weight Decreased

Pulmonary embolism

Myocardial infarction

Dehydration

Myocardial Infarction

Lower Respiratory Tract Infection

Abdominal Pain

Orthostatic Hypotension

General Physical Health Deterioration

Condition aggravated

General physical health deterioration

Hyponatraemia

Orthostatic hypotension

Lower respiratory tract infection

Syncope

Productive cough

Nasal congestion

Respiratory failure

Weight decreased

Chills

Gastroenteritis

Sepsis

Respiratory Failure

Condition Aggravated

100%

80%

60%

40%

20%

Study treatment Arm

Bortezomib + Dexamethasone (Vd)

Daratumumab + Bortezomib and Dexamethasone (DVd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: InterventionalExperimental Treatment1 Intervention

Phase 1: 3 dose levels to determine safety (15 patients) Dose expansion: Daratumumab (DARA) treatment post-HCT 1. Induction: DARA IV weekly x 8 doses (Weeks 1-8) 2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24) 3. 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

0 / 7Eligibility criteria met