CompletedPhase 1

Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia

United States55 participantsStarted 2002-05

Plain-language summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.

Who can participate

Age range

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: * One of the following histologically confirmed diagnoses: * Acquired severe aplastic anemia * Meets at least 2 of the following criteria: * Granulocyte count less than 500/mm\^3 * Platelet count less than 20,000/mm\^3 * Absolute reticulocyte count less than 20,000/mm\^3 (after correction for hematocrit) * Unresponsive to OR recurrent disease after prior treatment with anti-thymocyte globulin and/or cyclosporine * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * Failed induction therapy * In first complete remission (CR) with any of the following high-risk features: * Stem cell or biphenotype classification (M0) * Erythroleukemia (M6) * Acute megakaryocytic leukemia (M7) * Cytogenetic markers indicative of poor prognosis * t(15;17) translocation and failed first-line induction therapy OR there is molecular evidence of persistent disease * t(8;21) and inv(16) translocations and failed first-line induction therapy * In early relapse\* * In second or subsequent remission * Recurrent disease after prior autologous stem cell transplantation (SCT) NOTE: \*No refractory relapse * Acute lymphoblastic leukemia, meeting 1 of the following criteria: * In early relapse\* * In second or subsequent remission * In first CR with the following high-risk features: * t(4;11) or t(9;22) translocation * Hyperleukocytosis (initial WBC …

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

Event-free survival by disease assessment

Timeframe: at 28 and 100 days and then at 6, 9, 12, 18, and 24 months

Trial details

NCT IDNCT00054236

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-03

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