CompletedNot Applicable

AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders

United States10 participantsStarted 2005-08-16

Plain-language summary

RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the 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. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant work in treating patients with relapsed or refractory hematologic cancer.

Who can participate

Age range

0 Years – 120 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: * Histologically confirmed hematological or lymphatic malignancy, including any of the following: * Acute myeloid leukemia * Relapsed or primary refractory disease with \< 10% blasts on peripheral blood smear * In first remission with poor risk factors and molecular prognosis \[i.e., AML with -5, -7, t(6;9), tri8, -11\] (preparative regimen 3 or 4) * Acute lymphocytic leukemia * In second complete remission or higher OR in first remission with poor risk factors, including any of the following (preparative regimen 1 or 2): * BCR/ABL by fluorescence in situ hybridization (FISH) or reverse transcriptase-polymerase chain reaction * t(9;22)(q34;q11) detected by cytogenetics * Chromosomes \< 44 by cytogenetics * DNA index \< 0.81 by flow cytometry * Any rearrangement of chromosome 11 that results in disruption of MLL gene (11q23) by cytogenetics and SER * In first remission with poor risk factors and molecular prognosis \[ALL with Philadelphia chromosome-positive t(9;22), t(4;22), (q34;q11)\] (preparative regimen 3 or 4) * Chronic myelogenous leukemia * In accelerated phase or greater (preparative regimen 1 or 2) * In accelerated or second chronic phase (preparative regimen 3 or 4) * Myelodysplastic syndromes * With deletion of chromosome 7 or short arm of chromosome 5 (preparative regimen 1 or 2) * In high and high-intermediate risk categories (preparative regimen 3 or 4) * Non-…

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

Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)

Timeframe: From transplant to Day 100 post-transplant

Trial details

NCT IDNCT00547196

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11-11

Results submitted2023-03-21

View on ClinicalTrials.gov More Leukemia trials