TerminatedPhase 2

T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases

Stopped: slow accrual

United States13 participantsStarted 2004-01

Plain-language summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant followed by delayed T cell infusions in treating patients with hematologic cancer or other disease.

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.

DISEASE CHARACTERISTICS: * Diagnosis of any of the following hematologic cancers or other diseases: * Acute myelogenous leukemia * Relapsed or refractory disease with poor-risk cytogenetics * Acute lymphoblastic leukemia * Relapsed or refractory disease with poor-risk cytogenetics * Chronic myelogenous leukemia * Persistent disease after at least 6 months of treatment with imatinib mesylate (Gleevec) * Myelodysplasia, meeting 1 of the following criteria: * French-American-British Classification of refractory anemia with excess blasts (RAEB) or RAEB with transformation * International Prognostic Scoring System score \> 2 * Lymphoid malignancies, including non-Hodgkin lymphoma, Hodgkin disease, chronic lymphocytic leukemia, and prolymphocytic leukemia * Relapsed or refractory disease after at least 1 prior therapy * Myelofibrosis * Transfusion dependent (RBC's, platelets, or both) * Paroxysmal nocturnal hemoglobinuria (transfusion dependent) * Myeloproliferative disorder * Eosinophilic leukemia * Severe aplastic anemia * Corrected reticulocyte count \< 1% * Platelet count \< 30,000/mm³ (untransfused) * Bone marrow biopsy with \< 15% cellularity * Plasma cell leukemia * No essential thrombocytopenia or polycythemia vera * No matched related donor available * Must have an 8/8 or 7/8 serologic HLA matched unrelated donor available PATIENT CHARACTERISTICS: * Cardiac ejection fraction ≥ 45% (if \< 45%, then car…

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

Treatment-related Mortality (TRM)

Timeframe: 180 days after transplant

Trial details

NCT IDNCT00589602

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2016-09-20

View on ClinicalTrials.gov More Chronic Myeloproliferative Disorders trials