CompletedPhase 1

Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies

United States16 participantsStarted 2012-01

Plain-language summary

This phase 1 trial studies the side effects and the best dose of donor CD8+ memory T-cells in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-cancer effects). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect

Who can participate

Age range

18 Years – 75 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: * Patients must have undergone a human leukocyte antigen (HLA) matched (sibling) allogeneic HCT for a hematologic or lymphoid malignancy other than chronic myelogenous leukemia (CML) who have recurrent or persistent disease and are otherwise eligible for donor leukocyte infusions CML patients with persistent disease after receiving donor lymphocyte infusion of at least 1x10\^8cells/kg will be eligible for CD8+ memory T cell infusion * Patients must have no evidence of active graft-versus-host disease and must be on a stable immunosuppressive regimen without a change in drugs dosage in the 4 weeks prior to the planned CD8+ memory T cell infusion * Patients must not have any active infections * Patients must have a performance status of \> 70% on the Karnofsky scale * Serum creatinine of \< 2 mg/dl or creatinine clearance of \> 50 cc/min * Bilirubin of \< 3 mg/dl Transaminases \< 3 times the upper limit of normal * Patients must have negative antibody serology for the human immunodeficiency virus (HIV1 and 2) and hepatitis C virus and negative test for hepatitis B surface antigen DONOR: * Donors must be an HLA matched sibling * Donors must be 18-75 years of age, inclusive * Donors must be in a state of general good health * Donors must have a white blood cell count \> 3.5 x 10\^9/liter DONOR: Platelets \> 150 x 10\^9/liter * Donors: Hematocrit \> 35% * Donors must be capable of undergoing leukapheresis * Donors must not be seropositive for HIV 1 and 2, He…

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

Occurrence (individual listings and summary) of dose-limiting toxicities

Timeframe: 60 days following CD8+ memory T-cell infusion

Incidence of GVHD

Timeframe: Change from Baseline to 60 days following the CD8+ memory T-cell infusion

Trial details

NCT IDNCT01523223

SponsorRobert Lowsky

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

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