What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly those involving radioimmunotherapy like CLR 131, include tositumomab and iodine I 131 tositumomab. The major side effects of these treatments are hematologic toxicities, which are dose-limiting but generally predictable, transient, and manageable. Nonhematologic adverse events are typically mild to moderate in severity and transient. Other potential side effects include infusion reactions, neutropenia, thrombocytopenia, and infections. These treatments require careful patient-specific dosimetry to minimize toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for lymphoma that involve targeted delivery of cytotoxic agents or radioisotopes. One notable example is the approval of radioimmunotherapy agents like Zevalin (ibritumomab tiuxetan) and Bexxar (tositumomab), which combine monoclonal antibodies with radioactive isotopes to target and destroy lymphoma cells. Additionally, antibody-drug conjugates such as Adcetris (brentuximab vedotin) and Polivy (polatuzumab vedotin) have been approved, which deliver cytotoxic agents directly to cancer cells. These treatments share similarities with CLR 131 in their targeted approach to delivering cytotoxic effects to lymphoma cells.

What other types of research exist?

Promising novel alternatives to CLR 131 for lymphoma patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed or refractory lymphoma. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 on B-cells and engage T-cells to kill the cancer cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Novel small molecule inhibitors targeting pathways like BTK (e.g., ibrutinib) and PI3K (e.g., idelalisib). These therapies offer targeted mechanisms of action and have demonstrated promising results in clinical trials.

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Radioisotope

CLR 131 for Pediatric Cancer (CLOVER-2 Trial)

Phase 1

Waitlist Available

Research Sponsored by Cellectar Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have adequate kidney function

All Patients must have previously confirmed pediatric solid tumor, lymphoma, or malignant brain tumors that are relapsed, refractory, or recurrent with no standard treatment options

Must not have

Patients previously treated with high doses of iodine-131 (131I)-MIBG

Patients receiving active treatment for central nervous system metastases or likely to require active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CLR 131, a radioactive medicine designed to target and kill cancer cells. It is aimed at children, adolescents, and young adults whose cancers have returned or do not respond to other treatments. CLR 131 works by delivering radiation directly to the cancer cells, reducing harm to healthy cells.

Who is the study for?

This trial is for young people aged 2-25 with certain types of cancer (like neuroblastoma, sarcomas) that have come back or didn't respond to treatment. They should be fairly active (able to care for themselves), have decent blood counts and organ function, and not be on other cancer treatments. Those who've had a bone marrow transplant must wait at least 3 months before joining.

What is being tested?

The study tests CLR 131 in children and young adults with relapsed or stubborn cancers including brain tumors, lymphomas, and solid tumors like osteosarcoma. It aims to find out if this drug can help when other treatments haven't worked.

What are the potential side effects?

Possible side effects aren't specified here but generally may include nausea, fatigue, lowered blood counts leading to increased infection risk, potential kidney or liver issues due to the drug's toxicity profile.

Eligibility Criteria

Inclusion Criteria

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

Select...

My kidneys are working well.

Select...

My child's cancer has come back or hasn't responded to treatment and there are no standard treatments left.

Select...

My child has a solid tumor or lymphoma with at least one measurable lesion, or meets the criteria for neuroblastoma.

Select...

I meet the specific criteria for brain metastases treatment.

Select...

I have a brain tumor that has come back or didn't respond to treatment, with at least one tumor that can be measured. I also meet specific requirements for neurological symptoms and steroid use.

Select...

I am between 2 and 25 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with high doses of iodine-131 for my condition.

Select...

I am currently being treated for brain metastases or might need treatment soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with dose limiting toxicities (DLT)

Secondary study objectives

Determination of event free survival following CLR 131 infusion in children, adolescents, and young adults

Determination of overall survival following CLR 131 infusion in children, adolescents, and young adults

Determination of preliminary antitumor activity of CLR 131 in children, adolescents, and young adults

+3 more

Side effects data

From 2024 Phase 1 trial • 12 Patients • NCT04105543

92%

White blood cell decreased

83%

Lymphocyte count decreased

83%

Neutrophil count decreased

83%

Anemia

75%

Platelet count decreased

67%

Fatigue

50%

Mucositis oral

50%

Dermatitis radiation

42%

Dry mouth

42%

Anorexia

33%

Dysphagia

33%

Weight loss

33%

Headache

25%

Nausea

25%

Oral Pharyngeal pain

25%

Hypotension

17%

Constipation

17%

Mucosal infection

17%

Febrile neutropenia

17%

Dizziness

17%

Pain

17%

Dysgeusia

Stridor

Depression

Salivary duct inflammation

Watering eyes

Syncope

Superficial thrombophlebitis

Vomiting

Epistaxis

Respiratory failure

Diarrhea

Hypoxia

Neck Pain

Aspiration

Neuralgia

Fever

Neck edema

Metabolism and nutrition disorders - Other, specify

Thrush

Tinnitus

Dysarthria

Dehydration

Trismus

Erythema multiforme

Paresthesia

Chills

Dyspnea

Hypertension

Thyroid stimulating hormone increased

Tumor hemorrhage

Rash Maculo-papular

Dry eye

Fibrosis deep connective tissue

Osteonecrosis of jaw

Tumor pain

Laryngitis

Lymphedema

100%

80%

60%

40%

20%

Study treatment Arm

CLR 131 Dose Escalation

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: CLR 131Experimental Treatment1 Intervention

CLR 131 intravenous administration

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CLR 131

2019

Completed Phase 1

~20

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lymphoma include monoclonal antibodies, small-molecule inhibitors, chemotherapy, and radioimmunotherapy. Monoclonal antibodies, such as rituximab, target specific antigens on lymphoma cells, marking them for destruction by the immune system. Small-molecule inhibitors, like BTK or BCL2 inhibitors, interfere with signaling pathways essential for lymphoma cell survival and proliferation. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Radioimmunotherapy, exemplified by CLR 131, combines targeted delivery of a radioactive isotope to lymphoma cells, causing localized radiation damage and cell death. These treatments are crucial as they offer targeted and effective options to manage and potentially eradicate lymphoma, improving patient outcomes and survival rates.

Treatment challenges in the management of relapsed or refractory non-Hodgkin's lymphoma - novel and emerging therapies.