← Back to Search

Checkpoint Inhibitors for Cancer Recurrence After Stem Cell Transplant (CPIT001 Trial)

Phase 1 & 2
Waitlist Available
Led By Michele Donato, MD
Research Sponsored by Hackensack Meridian Health
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 26 weeks
Awards & highlights

CPIT001 Trial Summary

This trial is testing a new cancer treatment that uses the body's own immune system to fight the disease.

Who is the study for?
This trial is for adults aged 18-80 with high-risk or recurrent lymphoma or multiple myeloma, eligible for stem cell transplantation. Participants must not have autoimmune diseases, active infections requiring IV therapy, known allergies to the study drugs, or be pregnant/breastfeeding. They should agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests Ipilimumab and Nivolumab after autologous stem cell transplantation in patients with high-risk/recurrent disease. It aims to assess safety, immune response post-transplantation, complete response rates, progression-free survival and analyze the gut microbiome throughout treatment.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation of organs (like pneumonitis), infusion reactions which may cause symptoms like fever or chills during drug administration, fatigue, digestive issues possibly including diarrhea or nausea and increased risk of infection.

CPIT001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of combined check point inhibition therapy via assessment of adverse events and lab findings

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

CPIT001 Trial Design

1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment2 Interventions
Ipilimumab 1 mg/kg; 6 doses Weeks 1, 4, 7, 10, 16, 22 Nivolumab 3 mg/kg; 12 doses Weeks 1, 4, 7, 10, 12, 14, 16, 18, 20, 22, 24, 26
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,209 Total Patients Enrolled
6 Trials studying Lymphoma
403 Patients Enrolled for Lymphoma
Michele Donato, MDPrincipal InvestigatorHackensack Meridian Health
5 Previous Clinical Trials
285 Total Patients Enrolled

Media Library

Ipilimumab Clinical Trial Eligibility Overview. Trial Name: NCT02681302 — Phase 1 & 2
Lymphoma Research Study Groups: All Participants
Lymphoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02681302 — Phase 1 & 2
Ipilimumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT02681302 — Phase 1 & 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 number of participants currently registered for this research project?

"Unfortunately, this medical study is presently not accepting applicants. It was first posted on June 7th 2016 and last updated on December 2nd 2022; however, there are 3304 lymphoma trials and 764 Ipilimumab studies which currently require participants."

Answered by AI

Are there open opportunities for people to participate in this trial?

"The clinical study detailed on clinicaltrials.gov is not currently recruiting participants, despite its June 7th 2016 posting and December 2nd 2022 update. Nevertheless, there are 4068 other medical trials actively enrolling patients at the moment."

Answered by AI

Have other studies been conducted to evaluate the effectiveness of Ipilimumab?

"Currently, there are 764 ongoing clinical trials for Ipilimumab with 87 of them in their final stages. The majority of these studies have been conducted out of Pittsburgh, Pennsylvania however they can be found at 44,216 other locations worldwide."

Answered by AI

What indications typically warrant a prescription of Ipilimumab?

"Ipilimumab is a widely employed therapy for curbing the effects of anti-angiogenesis, and can also be used to combat an array of malignancies such as melanoma, squamous cell carcinoma, or other neoplastic growths."

Answered by AI

Is this trial accessible to participants with advanced age?

"This clinical trial requires participants to be in the 18-80 age range. There are 505 studies suitable for minors and 3786 that cater specifically to seniors."

Answered by AI

What criteria must potential participants meet in order to enroll in this experiment?

"This clinical trial is accepting 35 individuals aged between 18 and 80 who presently have lymphoma. Additionally, they must meet the following conditions: (GROUP D) patients having recurrent T cell lymphoma with at least stable disease after salvage therapy; Voluntary signed and dated IRB/IEC approved written informed consent form in accordance to regulatory and local regulations; Being of legal age on the signing date for their consent; (GROUP A) De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab plus anthracycline based multi-agent chemotherapy as well as remaining stationary after"

Answered by AI
Recent research and studies
~0 spots leftby May 2024