Active — Not RecruitingPhase 2

Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders

260 participantsStarted 2001-10-16

Plain-language summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell 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 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 tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.

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: * Diagnosis of one of the following: * Acute lymphocytic leukemia (ALL), meeting one of the following criteria: * In first relapse or beyond * High-risk ALL, defined by any of the following: * Hypoploidy (≤ 44 chromosomes) * Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14), excluding B-cell ALL * Elevated WBC at presentation (WBC \> 20,000/mm³ \[for patients \> 18 years of age\]; WBC \> 200,000/mm³ \[for patients 12-18 years of age\]) * Acute myeloid leukemia (AML), meeting one of the following criteria: * In first complete remission * Failed to achieve remission * In first relapse or beyond * Secondary AML (\> 30% blasts in marrow aspirate) * Should receive induction chemotherapy to obtain remission, if possible, before transplant * Chronic myelogenous leukemia, meeting one of the following criteria: * In first or second chronic phase or accelerated phase * In blast crisis, defined as \> 30% promyelocytes plus blasts in the bone marrow * Myelodysplastic syndromes, including any of the following: * Refractory anemia with excess blasts (RAEB) * Chronic myelomonocytic leukemia * RAEB in transformation * Refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma, or multiple myeloma * Received and failed front-line therapy, high-dose therapy and autologous stem cell transplantation, or salvage therapy * 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.

1This trial is specifically measuring how many days it takes for neutrophil counts to recover after the transplant — what does that timeline typically look like, and how does a slower or faster engraftment affect my overall recovery and risk of infection?
2Since this is a Phase 2 trial using donor peripheral stem cells, what is currently known about the safety profile compared to a standard bone marrow transplant, and are there particular risks I should weigh given my specific diagnosis?
3The trial is listed as active but no longer recruiting — does that mean there's any possibility I could still be considered, or would you recommend I look into a similar transplant approach through a different study or standard-of-care pathway?
4Graft versus host disease is listed as one of the conditions connected to this trial, which tells me it's a real concern with this type of transplant — how would you manage that risk for me specifically, and what are the short- and long-term consequences if it does develop?
5Given that my condition falls under the broad category of hematologic cancers or disorders this trial is targeting, do you think a donor peripheral stem cell transplant is the right next step for me, or would it make more sense to try other treatments first before considering a transplant approach?

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

Neutrophil Engraftment - The Days Till ANC Recovery

Timeframe: Up to 180 days post transplant

Trial details

NCT IDNCT00544115

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-03-13

Results submitted2023-03-09

View on ClinicalTrials.gov More Chronic Myeloproliferative Disorders trials