CompletedPhase 2

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

United States41 participantsStarted 2002-01-29

Plain-language summary

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.

Who can participate

Age range

4 Years – 75 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 aplastic anemia * Severe disease * Failed at least 1 course of standard immunosuppressive regimen with cyclosporine and anti-thymocyte globulin OR * Histologically confirmed hematologic malignancy including the following: * Acute leukemia * Any of the following types: * Acute myeloid leukemia (AML) with antecedent myelodysplastic syndromes * Secondary AML * AML with high-risk cytogenetic abnormalities * Acute lymphoblastic leukemia with high-risk cytogenetic abnormalities * Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen OR * In first remission at high risk of relapse * Chronic myelogenous leukemia * Chronic phase meeting at least 1 of the following criteria: * Failed imatinib mesylate * Failed interferon after at least 6 months of treatment with minimum of 21 million units of interferon per week * Unable to tolerate interferon * Accelerated phase (blasts less than 20%) * Myeloproliferative and myelodysplastic syndromes * Myelofibrosis (after splenectomy) * Refractory anemia * Refractory anemia with excess blasts * Chronic myelomonocytic leukemia * Lymphoproliferative disease * Chronic lymphocytic leukemia * Symptomatic disease after first-line chemotherapy * Low-grade non-Hodgkin's lymphoma (recurrent or persistent) * Symptomatic disease after first-line chemotherapy …

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

Day 100 TRM

Timeframe: from start or conditioning (day -6 or -5) through day +100 after HSC infusion

Day 100 Best Response

Timeframe: from start of conditioning on day -6 or -5 through day +100 after HSC infusion

Trial details

NCT IDNCT00053989

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-19

Results submitted2019-12-19

View on ClinicalTrials.gov More Chronic Myeloproliferative Disorders trials