Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Infectious Disease, Lymphoma, Women's Studies, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:April 9, 2013

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A Phase I/IB Study of Ipilimumab or Nivolumab in Patients With Relapsed Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation

This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in
treating patients with cancers of the blood and blood-forming tissues (hematologic cancers)
that have returned after a period of improvement (relapsed) after donor stem cell transplant.
Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of
cancer cells to grow and spread.

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose (MTD) of ipilimumab or nivolumab administered to
patients with relapsed hematologic malignancies following allogeneic stem cell
transplantation. (Phase I) II. To characterize the toxicity of ipilimumab or nivolumab
administered at the MTD in this patient population. (Phase Ib)

SECONDARY OBJECTIVES:

I. To assess response rate. II. To assess progression free and overall survival.

TERTIARY OBJECTIVES:

I. To assess the phenotypic and functional effects of ipilimumab or nivolumab on immune
cells.

OUTLINE: This is a dose-escalation study.

INDUCTION PHASE: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment
repeats every 14 days for 8 courses in the absence of disease progression or unacceptable
toxicity.

MAINTENANCE PHASE: Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 12
weeks beginning at course 5 (24 weeks after the first dose of ipilimumab) for up to 4 courses
in the absence of disease progression or unacceptable toxicity. Patients achieving clinical
benefit will have the option to continue with ongoing maintenance dosing every 12 weeks in
the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab
IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable
toxicity. Treatment repeats every 14 days for up to a total of 60 weeks (including Induction)
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year.

Inclusion Criteria:

- Histologically or cytologically confirmed hematologic malignancy

- The following malignancies will be considered eligible if progressive or persistent:

- Chronic lymphocytic leukemia (CLL)

- Non-Hodgkin lymphoma (NHL)

- Hodgkin lymphoma (HL)

- Multiple myeloma (MM)

- Acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL])

- Myelodysplastic syndrome (MDS)

- Myeloproliferative neoplasms (MPN)

- Chronic myeloid leukemia (CML)

- Life expectancy of greater than 3 months

- Must have undergone allogeneic hematopoietic stem cell transplantation (HSCT)
(regardless of stem cell source)

- Must have baseline donor T cell chimerism of >= 20%

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to
Gilbert's disease or disease-related hemolysis, then =< 3.0 x ULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3.0 x institutional ULN

- Creatinine =< 1.5 x institutional ULN

- Prednisone dose =< 5 mg/day and off all other systemic immunosuppressive medications
for at least 4 weeks prior to study entry

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Participants who have had anti-tumor therapy or other investigational agents within 4
weeks prior to registration (6 weeks for nitrosoureas or mitomycin C), or those who
have not recovered from adverse events due to agents administered more than 4 weeks
prior to registration

- Patients with prior history of or active severe (grade 3 or 4) acute graft-versus-host
disease (GVHD)

- Patients with a history of prior treatment with ipilimumab, anti-programmed cell death
protein 1 (PD 1) antibody, or cluster of differentiation (CD)137 agonist therapy are
ineligible for the ipilimumab arm, but are eligible for the nivolumab arm

- Patients who have had donor lymphocyte infusion (DLI) within 8 weeks prior to
registration

- 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

- Patients with known chronic human immunodeficiency virus (HIV), hepatitis B or
hepatitis C infections should be excluded

- 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; 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 or nivolumab administration
We found this trial at
12
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David E. Avigan
Phone: 617-667-9920
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Alex F. Herrera
Phone: 626-256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Duarte, CA
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Asad Bashey
Phone: 404-255-1930
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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Atlanta, Georgia 30342
Principal Investigator: Asad Bashey
Phone: 404-255-1930
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Atlanta, GA
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Jens Rueter
Phone: 207-973-7478
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Yi-Bin A. Chen
Phone: 617-724-1124
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Matthew S. Davids
Phone: 617-632-6331
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Brewer, Maine 04412
Phone: 800-987-3005
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Charlestown, Massachusetts 02129
Principal Investigator: Yi-Bin A. Chen
Phone: 617-724-1124
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Phone: 888-785-6789
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Denver, CO
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: Caitlin Costello
Phone: 858-822-6842
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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Tampa, Florida 33612
Principal Investigator: Frederick L. Locke
Phone: 813-745-8248
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Tampa, FL
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