CompletedPhase 1

Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer

United States7 participantsStarted 2004-09

Plain-language summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy 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 chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.

Who can participate

Age range

18 Years – 70 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 1 of the following advanced hematologic malignancies: * Acute myeloid leukemia (AML) meeting the following criteria: * Considered incurable with chemotherapy * Marrow blasts ≤ 10% (may be achieved using standard chemotherapy regimen) * Meets any of the following criteria: * High-risk cytogenetics (-7, -7q, -5, -5q, t(6,9), t(9,11), complex \[≥ 3 abnormalities\], Philadelphia chromosome positive \[Ph+\]) * AML evolved from prior myelodysplasia * AML secondary to prior chemotherapy * Failed to achieve remission * In second or subsequent remission * Refractory relapse * Myelodysplastic syndromes (MDS) meeting the following criteria: * Must have high-risk features, including any of the following: * Intermediate-2 or high risk International Prognostic Scoring System (IPSS) score * Chronic myelomonocytic leukemia * Marrow blasts ≤ 20% (chemotherapy may be given to achieve target blast levels) * No rapidly progressive disease * Acute lymphoblastic leukemia meeting the following criteria: * Considered incurable with chemotherapy * Meets any of the following criteria: * High-risk cytogenetics (Ph+, t(4,11), 11q23 abnormalities, or monosomy 7) * Required \> 1 induction course to achieve remission * Failed to enter remission * In second or subsequent remission * Marrow blasts ≤ 10% (chemotherapy may be given to achieve target b…

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

Safety and Feasibility of donor cord blood transplant

Timeframe: up to 36 months post transplant

Trial details

NCT IDNCT00301951

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07

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