Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor S… (NCT01822509) | Clinical Trial Compass
CompletedPhase 1
Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant
United States71 participantsStarted 2013-05-16
Plain-language summary
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. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD) of ipilimumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)
Timeframe: At 12 weeks
2
Maximum tolerated dose (MTD) of nivolumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)
Timeframe: At 12 weeks
3
Incidence of adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase Ib)
Timeframe: Up to 1 year after completion of study treatment