What is the mechanism of action of this treatment?

Common treatments for weight loss often include immunotherapy and chemotherapy-like approaches. Immunotherapy works by inducing changes in the immune system to help it recognize and attack abnormal cells, which can be relevant for weight loss if the immune system targets fat cells or related metabolic pathways. Chemotherapy involves drugs that kill rapidly dividing cells, stop their division, or prevent their spread. These mechanisms matter for weight loss patients as they offer potential strategies to target and reduce fat cells or alter metabolic processes, thereby aiding in weight reduction.

What side effects are associated with this type of intervention?

Common treatments for weight loss, particularly those involving immunotherapy and chemotherapy, can have a range of side effects. Immunotherapy can lead to immune-related adverse effects such as fatigue, skin rashes, diarrhea, and inflammation of organs like the lungs (pneumonitis) or liver (hepatitis). Chemotherapy, on the other hand, often causes side effects including nausea, vomiting, hair loss, fatigue, increased risk of infections due to lowered white blood cell counts, and potential damage to organs such as the heart or kidneys. Both types of treatments require careful monitoring and management of side effects to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

FDA-approved treatments for weight loss primarily include medications that act on the central nervous system to suppress appetite or increase feelings of fullness, such as phentermine-topiramate, naltrexone-bupropion, and liraglutide. These drugs do not function through immunotherapy or chemotherapy mechanisms like Obinutuzumab and Lenalidomide. Instead, they target neurotransmitters or hormones involved in hunger and satiety. Currently, there are no FDA-approved weight loss treatments that utilize immunotherapy or chemotherapy-like mechanisms.

What other types of research exist?

Promising novel alternatives to Obinutuzumab and Lenalidomide for cancer treatment include: 1) Chimeric Antigen Receptor T cells (CAR-T cells) such as idecabtagene vicleucel and ciltacabtagene autoleucel, which are designed to target specific cancer antigens. 2) Bispecific T cell engagers (BiTEs) like teclistamab, AMG 701, and CC93269, which direct T cells to attack cancer cells. 3) Anti-BCMA antibody drug conjugates like belantamab mafodotin, which target the B-cell maturation antigen. 4) CELMoDs targeting cereblon, such as iberdomide and CC92480, which modulate the immune response against cancer cells. 5) Oncolytic viruses, which selectively infect and kill cancer cells while stimulating an anti-tumor immune response.

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Immunomodulatory Agent

Obinutuzumab + Lenalidomide for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Loretta J Nastoupil

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Negative pregnancy test for women of childbearing potential

Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by CT, PET/CT, and/or MRI

Must not have

Grade 3b follicular lymphoma

Recent live, attenuated vaccine administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well obinutuzumab and lenalidomide work together to treat patients with untreated follicular lymphoma. Obinutuzumab helps the immune system fight cancer, and lenalidomide stops cancer cells from growing and spreading. The combination aims to be more effective for these patients. Obinutuzumab and lenalidomide (referred to as the GALEN combination) is an active treatment with a safety profile that is considered manageable in multiple types of lymphoma.

Who is the study for?

This trial is for adults with untreated stage II-IV grade 1-3a follicular lymphoma. Participants must have measurable disease, be in need of treatment, and have an ECOG performance status of <=2. They should not be pregnant or breastfeeding and must use reliable contraception. Exclusions include a history of other cancers (unless disease-free for 5 years), serious illnesses, certain heart conditions, prior lenalidomide use, active infections like HIV or hepatitis B/C.

What is being tested?

The trial tests the combination of obinutuzumab (an immunotherapy) and lenalidomide (a chemotherapy drug) to see if they are more effective when used together in treating patients who haven't had previous treatments for follicular lymphoma.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's activation by obinutuzumab, such as infusion reactions or organ inflammation. Lenalidomide can cause blood disorders, fatigue, digestive issues and increase the risk of developing new cancers.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant.

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I have a tumor that is at least 2 cm large, confirmed by imaging tests.

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I have been diagnosed with a type of lymphoma (grades 1, 2, or 3a) and have not received treatment.

Exclusion Criteria

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

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My condition is Grade 3b follicular lymphoma.

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I have recently received a live vaccine.

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I have active cancer in my brain or spinal cord.

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I have previously taken lenalidomide.

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I am currently on medication that suppresses my immune system.

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I have a serious heart condition.

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I have a specific blood clotting condition.

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My follicular lymphoma has transformed into a more aggressive form.

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I have a serious illness or organ problem.

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I do not have HIV, active hepatitis B or C, or any uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Progression free survival

Secondary study objectives

Complete response

Duration of response

Event free survival

+2 more

Side effects data

From 2019 Phase 3 trial • 229 Patients • NCT02264574

44%

Neutropenia

35%

Thrombocytopenia

35%

Diarrhea

29%

Cough

24%

Arthralgia

23%

Infusion related reaction

19%

Fatigue

19%

Back pain

19%

Hypertension

17%

Anaemia

17%

Constipation

17%

Pyrexia

16%

Upper respiratory tract infection

15%

Rash maculo-papular

14%

Muscle spasms

14%

Atrial fibrillation

13%

Hyperuricaemia

13%

Nausea

13%

Nasopharyngitis

12%

Insomnia

12%

Urinary tract infection

12%

Oedema peripheral

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Dyspnoea

11%

Vomiting

11%

Pain in extremity

11%

Dizziness

10%

Cataract

10%

Decreased appetite

Spontaneous haematoma

Anxiety

Fall

Rash

Headache

Iron deficiency

Abdominal pain

Dyspepsia

Vision blurred

Pruritus

Bronchitis

Lacrimation increased

Respiratory tract infection

Blood creatine increased

Productive cough

Oropharyngeal pain

Gastrooesophageal reflux disease

Hypokalaemia

Dry eye

Chills

Myalgia

Depression

Dry Skin

Ecchymosis

Onychoclasis

Palpitations

Stomatitis

Peripheral swelling

Epistaxis

Herpes zoster

Increased tendency to bruise

Hyperglycaemia

Musculoskeletal pain

Haematuria

Petechiae

Cellulitis

Contusion

Tremor

Febrile neutropenia

Adenocarcinoma of colon

Acute coronary syndrome

Gastroenteritis

Weight decreased

Septic shock

Femur fracture

Osteoarthritis

Transient ischaemic attack

Cardiac arrest

Angina pectoris

Death

Cerebrovascular accident

Acute kidney injury

Renal failure

Oesophageal rupture

Respiratory failure

Compartment syndrome

Invasive ductal breast carcinoma

Malignant melanoma

Non-small cell lung cancer

Uterine prolapse

Bronchitis chronic

Peripheral ischaemia

Colorectal cancer

Myelodysplastic syndrome

Haemoptysis

Pleural effusion

Bronchopulmonary aspergillosis

Cardiac failure congestive

Gastritis

Concussion

Arthritis

Inclusion body myositis

Colorectal cancer metastatic

Ischaemic stroke

Bacterial sepsis

Leukopenia

Acute myocardial infarction

Pericarditis

Stress cardiomyopathy

Goitre

Haemorrhoids

Impaired gastric emptying

Proctitis

Small intestinal obstruction

Catheter site haematoma

Multi-organ disorder

Cholelithiasis

Abscess

Bursitis infective staphylococcal

Erysipelas

Escherichia sepsis

Escherichia urinary tract infection

Infective aneurysm

Listeria sepsis

Lower respiratory tract infection

Pneumocystis jirovecii pneumonia

Pneumonia bacterial

Pneumonia klebsiella

Prostate infection

Sinusitis fungal

Urosepsis

Jaw fracture

Pubis fracture

Rib fracture

Spinal compression fracture

Thoracic vertebral fracture

Traumatic haematoma

Upper limb fracture

Diabetes mellitus inadequate control

Adenocarcinoma gastric

Basal cell carcinoma

Benign renal neoplasm

Squamous cell carcinoma

Syncope

Acute psychosis

Complete Suicide

Soft tissue infection

Osteoma

Atrial tachycardia

Retinal detachment

Herpes Zoster

Oral herpes

Pharyngitis

Streptococcal bacteraemia

Cardiac failure

Myocardial infarction

Sudden Death

Incisional hernia

Hypercalcaemia

Hypomagnesaemia

Aplastic anaemia

Inguinal hernia

Large intestine polyp

Cerebral ischaemia

Depressed level of consciousness

Confusional state

Nephrolithiasis

Urinary retention

Benign prostatic hyperplasia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

IBR+OB

CLB+OB

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: Treatment (obinutuzumab, lenalidomide)Experimental Treatment2 Interventions

Patients receive obinutuzumab IV over 4-6 hours on days 1, 8, and 15 of course 1 and day 1 of cycles 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30. Treatment repeats every 28 days for up to 30 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or CRu may receive up to an additional 12 cycles of lenalidomide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Obinutuzumab

2014

Completed Phase 3

~3470

0 / 13Eligibility 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 weight loss often include immunotherapy and chemotherapy-like approaches. Immunotherapy works by inducing changes in the immune system to help it recognize and attack abnormal cells, which can be relevant for weight loss if the immune system targets fat cells or related metabolic pathways. Chemotherapy involves drugs that kill rapidly dividing cells, stop their division, or prevent their spread. These mechanisms matter for weight loss patients as they offer potential strategies to target and reduce fat cells or alter metabolic processes, thereby aiding in weight reduction.

Trial Watch: Lenalidomide-based immunochemotherapy.Novel therapies in the treatment of multiple myeloma.