• Patient Stories
  • Understanding MPNs
    • Understanding MPNS
    • What Is Polycythemia Vera?
    • What Is Essential Thrombocythemia?
    • What Is Primary Myelofibrosis?
  • Resources
    • Empowered Patients
    • Dictionary
    • Resources
  • Partners
    • Industry Partners
    • International MPN Organizations
    • Partners
  • News Feed
  • Contact
  • MPN Search

PV Reporter

MPN Information and Research Hub

  • About
    • About Us
    • MPN Cancer Connection
    • Contact Us
  • MPN Specialists
  • Blog
  • Media
    • Podcast
      • 01: Polycythemia Vera Diagnosis, PV Reporter, Day 1, Doomsday or Living with a Plan
      • 02: MPN Chronicles – Interview with Dr. Pemmaraju
      • 03: Learn Benefits of Becoming your own MPN Advocate
      • 04: First Hematologist appointment for PV patient
      • 05: Tips to Living Well with an MPN
      • 06: My Plan to beat Coronavirus Blues
    • Videos
    • Dr. Interviews
      • Dr. Jean Jacques Kiladjian ASH 2018 RuxoPeg Phase 1/2 Trial of the Combo of Ruxolitinib and Pegasys in Myelofibrosis Patients
      • Dr. Michael Grunwald ASH 2018 Risk Assessment and Treatment Myelofibrosis Patients at Community Oncology Practices in the U.S.
      • Dr. J.J. Kiladjian ASH 2018 Headline Research Studies
      • ASH 2017 Interview with Dr. Michael Grunwald
        • ASH 2017 Interview with Dr. Raajit Rampal, part 1
        • ASH 2017 with Dr. Raajit Rampal, part 2
        • ASH 2017 Interview with Dr. Jean Jacques Kiladjian, part 1
        • ASH 2017 Interview with Dr. Jean Jacques Kiladjian, part 2
      • ASH 2016 Interviews
        • ASH 2016 Interview with Dr Kiladjian
        • ASH 2016 Interview with Dr Rampal
      • ASH 2015 Interviews
        • ASH 2015 Interview with Dr John Mascarenhas
        • ASH 2015 Interview with Dr Angela Fleischman
      • ASH 2014 Interviews
        • ASH 2014 Interview with Dr Heinz Gisslinger
        • ASH 2014 interview with Dr Richard Stone
  • Treatment
    • How I Treat MPN’s
    • Jakafi
    • INREBIC
    • Interferon treatment for MPNs
  • Support Group

Clinical Trial Finder

Search Results

A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT

Study Purpose

In this research study, our main goal for the ipilimumab portion of the study is to determine the highest dose of ipilimumab that can be given safely in several courses and to determine what side effects are seen in patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasms (MPN), Chronic Myelomonocytic Leukemia (CMML), or Myelofibrosis (MF).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically or cytologically confirmed relapse of AML, MDS or MPN (CMML or myelofibrosis or MDS/MPN with ≥5% blasts in the marrow).
  • - Relapse at ≥2 months after first 8/8 HLA-matched HCT.
  • - Available original stem cell donor.
  • - Age ≥18 years.
Because no dosing or adverse event data are currently available on the use of Ipilimumab in participants <18 years of age, children are excluded from this study.
  • - ECOG performance status ≤2 (Karnofsky performance status ≥60, see Appendix A).
  • - Recipient donor T cell chimerism ≥20% within 4 weeks prior to cell infusion.
  • - <50% bone marrow involvement within 4 weeks prior to cell infusion.
  • - No systemic corticosteroid therapy for GVHD (≤5 mg of prednisone or equivalent doses of other systemic steroids for non-GVHD, non-autoimmune indications for at least 4 weeks prior to cell infusion).
  • - No other systemic medications/treatments (e.g. ECP) for GVHD for at least 4 weeks prior to cell infusion.
  • - Ability to understand and willingness to sign written informed consents.
  • - Adequate organ function as defined below: - Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then < 3 x ULN) - AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN.
  • - creatinine clearance: ≤1.5 x institutional ULN.
  • - O2 saturation: ≥90% on room air.
  • - LVEF >40% - The effects of CD25/Treg-depleted DLI and Ipilimumab on the developing human fetus are unknown.
For this reason and because immunomodulatory agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study or within 23 weeks after the last dose of study drug, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for at least 31 weeks after completion of Ipilimumab administration.
  • - Negative pregnancy test for females of childbearing potential only.

Exclusion Criteria:

  • - Extramedullary relapse involving immuno-privileged sites (e.g. CNS, testes, eyes).
Other sites of extramedullary relapse (e.g. leukemia cutis, granulocytic sarcoma) are acceptable.
  • - Participants who have had anti-tumor chemotherapy or other investigational agents within 4 weeks prior to cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior.
Use of hydroxyurea to control counts within 4 weeks prior to cell infusion is permitted.
  • - Prior history of DLI.
  • - Prior history of treatment with anti-CTLA-4 or anti-PD-1 pathway therapy, or CD137 agonist therapy.
  • - Prior history of severe (grade 3 or 4) acute GVHD, or ongoing active GVHD requiring systemic treatment.
  • - Organ transplant (allograft) recipient.
  • - History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ipilimumab or other agents used in study.
  • - Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
Patients with Hashimoto's thyroiditis are eligible to go on study.
  • - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • - Pregnant women are excluded from this study because of the unknown teratogenic risk.
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated on this study.
  • - HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with agents used in this study.
In addition, these participants are at increased risk of lethal infections when treated with marrow- suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
  • - Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after HCT.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03912064
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John Koreth, MD
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Myelofibrosis
Additional Details

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for this specific disease but it has been approved for other uses. This drug has been used in other research studies and is now FDA-approved for the treatment of melanoma. Many people have also received ipilimumab on research studies for possible treatment of prostate cancer, lymphoma, kidney cancer, ovarian cancer and HIV infection. Information from those other research studies suggests that ipilimumab may help to treat the participant's cancer. Ipilimumab is an antibody that acts against CTLA-4. An antibody is a common type of protein produced by the body that the immune system (a system that defends the body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in the body) such as bacteria and viruses.

Arms & Interventions

Arms

Experimental: CD25/Treg-depleted DLI + Ipilimumab

Ipilimumab is administered intravenously every 12 weeks Patients will receive a defined dose of CD25hi Treg depleted DLI intravenoudsly

Interventions

Drug: - Ipilimumab

Ipilimumab is an antibody that acts against CTLA-4

Biological: - CD25hi Treg depleted DLI

Donor lymphocyte product

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

John Koreth, MD

john_koreth@dfci.harvard.edu

617-632-5168

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Site Contact

John Koreth, MD

john_koreth@dfci.harvard.edu

617-632-5168

Powered By
The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

RSS MPN News

  • Contemporary Approach CALR Positive MPNs
  • 9 Tips to Reduce MPN Fatigue
  • Common Clinical Trial Acronyms and Abbreviations
  • Understanding the Phases of Clinical Trials
  • 4th Angel providing one-on-one support services for MPN Patients

MPN 2019 guidelines

MPN 2019 Guidelines, PV Reporter

Click on the image above for the New MPN Patient Guidelines! Very detailed, provided by NCCN.

Medical Dislaimer

Sign up for Our Newsletter!

Copyright · PV Reporter © 2021 · Site Design by David Wallace
error: