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Monoclonal Antibodies

Daratumumab + Ibrutinib for Chronic Lymphocytic Leukemia

Q: What is the enrollment quota for this research project?

Affirmative. According to clinicaltrials.gov, this medical study is presently looking for participants and has been since September 16th 2020. As of March 22nd 2022, the trial requires 52 individuals from 1 sites in order to reach completion.

Q: Is there still room to join this trial for potential participants?

As outlined on the clinicaltrials.gov website, this medical study is open for enrollment and has been updated recently (March 22nd 2022). The trial was initiated back in September 16th 2020.

Q: Are there any safety concerns associated with employing Daratumumab?

Due to the lack of evidence regarding Daratumumab's efficacy, our team assigned it a score of 2 on our safety scale. However, there is some prior data suggesting that it does have value in terms of its security profile.

Q: What diseases do doctors typically use Daratumumab to combat?

Daratumumab is utilized as a biological response modifier and can be applied to cases of refractory <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a>, relapsed or refractory forms of the condition, and cell transplants.

Q: Is there a precedent of research involving Daratumumab?

Currently, there are 291 clinical trials concerning Daratumumab with 49 of them in Phase 3. Though the majority take place in Karlsruhe and Quebec, over 12 thousand sites across the world are running this research.

Phase 2

Waitlist Available

Led By Sikander Ailawadhi

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have relapse or refractory CLL/SLL who have received at least 1 prior anti-CLL/small lymphocytic lymphoma (SLL) therapy. (Note: There is no upper limit of how many lines of therapy the patient may have received previously)

- Currently on ibrutinib and have failed to achieve either a complete remission after at least 12 cycles of treatment with ibrutinib or have suboptimal response (< partial response [PR]) after being on ibrutinib treatment for 6 cycles

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying whether a combination of daratumumab and ibrutinib is more effective than ibrutinib alone in treating relapsed or refractory chronic lymphocytic leukemia.

Who is the study for?

This trial is for adults with chronic lymphocytic leukemia (CLL) that has returned or didn't respond to treatment. They must have been on ibrutinib previously, have measurable disease, and be in decent physical condition. Participants need normal blood counts and liver function, not be pregnant or nursing, use effective birth control, and can't have severe lung conditions or other serious health issues.Check my eligibility

What is being tested?

The DIRECT Study is testing the combination of daratumumab (a monoclonal antibody) with ibrutinib (an enzyme blocker) against CLL that's relapsed or refractory. The goal is to see if this combo works better than just using ibrutinib alone for these patients.See study design

What are the potential side effects?

Possible side effects include immune system reactions leading to organ inflammation, infusion-related reactions from the antibodies, fatigue, digestive problems like nausea or diarrhea, low blood cell counts increasing infection risk, and potential liver abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have CLL/SLL that has come back or didn't respond to treatment, and I've had at least one prior therapy.

Select...

I've been on ibrutinib for at least 6 months without full remission.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

My condition is confirmed B-CLL as per specific medical guidelines.

Select...

My condition worsened despite taking ibrutinib.

Select...

My cancer can be measured by tests or scans.

Select...

I have CLL/SLL that has come back or didn't respond to treatment, and I've had at least one prior therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Incidence of adverse events

Minimal residual disease (MRD) response rate

Overall response rate

+1 more

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%

Arthralgia

20%

Oedema peripheral

19%

Neutropenia

19%

Dyspnoea

18%

Insomnia

17%

Pyrexia

16%

Oedema Peripheral

15%

Nausea

14%

Pain in extremity

14%

Lymphopenia

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

Urinary tract infection

Leukopenia

Bone pain

Decreased Appetite

Hyperglycaemia

Pain in Extremity

Bronchospasm

Weight decreased

Muscle Spasms

Abdominal pain upper

Alanine aminotransferase increased

Hypophosphataemia

Herpes zoster

Influenza

Hypocalcaemia

Alanine Aminotransferase Increased

Rash

Musculoskeletal Chest Pain

Myalgia

Aspartate aminotransferase increased

Nasal congestion

Abdominal pain

Bone Pain

Hypotension

Abdominal Pain Upper

Weight Decreased

Chills

Throat irritation

Productive cough

Herpes Zoster

Oedema

Paraesthesia

Epistaxis

Dyspepsia

Atrial fibrillation

Acute kidney injury

Sepsis

Atrial Fibrillation

Acute myocardial infarction

Pneumonia cytomegaloviral

Pleural effusion

Hip fracture

Rib fracture

Femur fracture

Lower Respiratory Tract Infection

Pulmonary sepsis

Squamous cell carcinoma of skin

Pulmonary Sepsis

Hypercalcaemia

Pneumonia Cytomegaloviral

Cardiac failure congestive

Acute coronary syndrome

Lower respiratory tract infection

Angina unstable

Cerebrovascular accident

Ischaemic stroke

Bronchitis chronic

Humerus fracture

Respiratory failure

Gastroenteritis

Pathological fracture

Febrile neutropenia

Ischaemic Stroke

Respiratory Failure

Pathological Fracture

Febrile Neutropenia

Cardiac Failure Congestive

Bronchopneumonia

Femur Fracture

Humerus Fracture

Acute Kidney Injury

Pleural Effusion

100%

80%

60%

40%

20%

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: Treatment (daratumumab, ibrutinib)Experimental Treatment2 Interventions

Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and then on day 1 of subsequent cycles. Beginning in cycle 2, patients also receive ibrutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~1890

Daratumumab

2014

Completed Phase 3

~1990

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,616 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,319 Total Patients Enrolled

Sikander AilawadhiPrincipal InvestigatorMayo Clinic

7 Previous Clinical Trials

4,104 Total Patients Enrolled

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04230304 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: Treatment (daratumumab, ibrutinib)

Chronic Lymphocytic Leukemia Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT04230304 — Phase 2

Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04230304 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment quota for this research project?

"Affirmative. According to clinicaltrials.gov, this medical study is presently looking for participants and has been since September 16th 2020. As of March 22nd 2022, the trial requires 52 individuals from 1 sites in order to reach completion."

Answered by AI

Is there still room to join this trial for potential participants?

"As outlined on the clinicaltrials.gov website, this medical study is open for enrollment and has been updated recently (March 22nd 2022). The trial was initiated back in September 16th 2020."

Answered by AI

Are there any safety concerns associated with employing Daratumumab?

"Due to the lack of evidence regarding Daratumumab's efficacy, our team assigned it a score of 2 on our safety scale. However, there is some prior data suggesting that it does have value in terms of its security profile."

Answered by AI

What diseases do doctors typically use Daratumumab to combat?

"Daratumumab is utilized as a biological response modifier and can be applied to cases of refractory multiple myeloma, relapsed or refractory forms of the condition, and cell transplants."

Answered by AI

Is there a precedent of research involving Daratumumab?

"Currently, there are 291 clinical trials concerning Daratumumab with 49 of them in Phase 3. Though the majority take place in Karlsruhe and Quebec, over 12 thousand sites across the world are running this research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study

2020. "Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230304.

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