TerminatedEarly Phase 1

Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies

Stopped: Lack of enrollment

United States2 participantsStarted 2020-10-26

Plain-language summary

This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.

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: * Patient with disease (stage) eligible per cohort * COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and ?high-risk? disease as defined below: * Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified World Health Organization \[WHO\] subtypes) not in computed tomography (CT)-positron emission tomography (PET) complete remission at time of high dose therapy * Diffuse large cell lymphoma with ?double hit? or ?double expressor? features * Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO specified subtypes) refractory to standard induction therapy OR relapsing within 1 year of treatment OR in greater that second complete remission (CR) * Mantle cell lymphoma not in CR1 * Multiple myeloma with ONE (or more) of the following high risk features: * Less than very good partial remission at time of high dose therapy * High Revised-International Staging System (R-ISS) (stage III ? 2 microglobulin \>= 5.5 plus lactate dehydrogenase \[LDH\] \> upper limit of normal \[ULN\] and/or del17p, t(4;14), t(14;16)) at time of diagnosis * Cytogenetics or fluorescent in situ hybridization (FISH) del17p * COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor with one of the following disease subtypes: * Acute myeloid leukemia (AML) in CR1 with high risk featur…

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

Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response

Timeframe: Up to 8 weeks after last protocol treatment

the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Timeframe: Up to 12 weeks of completion of therapy

Trial details

NCT IDNCT03272633

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2023-03-20

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials