CompletedPhase 1

T-Cell-Depleted Allogeneic Stem Cell Transplantation After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies

United States20 participantsStarted 2004-02

Plain-language summary

RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening. PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients with hematologic malignancies.

Who can participate

Age range

18 Years – 55 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 hematologic malignancies: * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * In first complete remission (CR1), meeting 1 of the following criteria: * Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following: * Complex karyotype \[≥ 3 abnormalities\] * inv(3) or t(3;3) * t(6;9) * t(6;11) * Monosomy 7 * Trisomy 8, alone or with an abnormality other than t(8;21), t(9;11), inv(16), or t(16;16) * t(11;19) (q23;p13.1) * Failed to achieve CR after primary induction chemotherapy * Secondary AML * In second or subsequent remission (CR2 or greater) * Acute lymphoblastic leukemia, meeting 1 of the following criteria: * In CR1, meeting 1 of the following criteria: * Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following: * Translocations involving 11q23, t(9;22), or bcr-abl rearrangement * Failed to achieve CR after primary induction chemotherapy * In CR2, if CR1 was \< 12 months * In CR3 or greater * Myelodysplastic syndromes (MDS) * INT-2 or high-risk by International Prognostic Scoring System * No MDS with Fanconi anemia * Chronic m…

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.

Trial details

NCT IDNCT00080925

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

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