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Monoclonal Antibodies
Mosunetuzumab for B Cell Acute Lymphoblastic Leukemia
Phase 1
Waitlist Available
Led By Nitin Jain, MBBS
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial studied a drug to find a safe dose for people with leukemia (ALL).
Eligible Conditions
- B Cell Acute Lymphoblastic Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Side effects data
From 2021 Phase 1 trial • 23 Patients • NCT0431360841%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Upper respiratory tract infection
6%
Thrombosis
6%
Cytomegalovirus infection reactivation
6%
Rash
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx
Trial Design
1Treatment groups
Experimental Treatment
Group I: MosunetuzumabExperimental Treatment1 Intervention
Participants will be assigned to a dose level of mosunetuzumab based on when the participants join this study. Up to 2 dose levels of mosunetuzumab will be tested. The first group of participants will receive the lowest dose level. A second group will receive a higher dose than the group before it, if no intolerable side effects were seen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,802 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,689 Total Patients Enrolled
Nitin Jain, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
73 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had stage I melanoma, low grade prostate cancer, or another type of cancer that has been fully treated and in remission for at least 2 years.If you have a thyroid condition called hypothyroidism but it is being treated with medication and your dosage is stable, you can still participate.It's okay if you use mineralocorticoids to manage low blood pressure when standing up.It's okay if you have taken a one-time dose of dexamethasone for nausea or other symptoms.You have experienced severe skin reactions in the past after using similar medications.If you don't want to get pregnant, you need to use very reliable birth control methods like getting your tubes tied, using an intrauterine device, or using hormonal contraceptives correctly. Barrier methods like condoms are okay, but you should also use a spermicide to be extra safe.You have received a special type of cell therapy called chimeric antigen receptor T cell therapy within the last 30 days.You are allowed to use inhaled corticosteroids.You have had a solid organ transplant in the past.You have had a serious allergic reaction to certain types of medicines called monoclonal antibodies.You have a history of serious liver disease, like hepatitis or cirrhosis.You have a history of autoimmune diseases like lupus, rheumatoid arthritis, or multiple sclerosis.You may be eligible if you have a history of certain immune-related blood disorders like immune thrombocytopenic purpura or autoimmune hemolytic anemia.It's okay to use steroids to reduce the size of tumors, as long as it meets the criteria mentioned earlier.You have received previous treatments for cancer as listed below:You have experienced severe side effects from previous treatments that have not fully improved before starting the study.You have had certain types of cancers in the past that were successfully treated, such as early-stage cervical cancer, certain types of breast cancer that have a good chance of recovery, or skin cancers like basal cell or squamous cell carcinoma.You have a condition where your immune system attacks your own body and you need treatment for it.You have a history or are suspected to have a condition called hemophagocytic lymphohistiocytosis (HLH).
Research Study Groups:
This trial has the following groups:- Group 1: Mosunetuzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment ongoing for this research endeavor?
"According to clinicaltrials.gov, the last update of this trial was on July 18th 2023 and it is not currently recruiting participants. Nevertheless, there are 1,503 other trials in search of candidates at present."
Answered by AI
Has the Mosunetuzumab drug been granted authorization by the FDA?
"Our team at Power has assigned a score of 1 to Mosunetuzumab's safety due to the fact that this is an early stage trial with limited evidence regarding efficacy and security."
Answered by AI
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