Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Rel… (NCT01701323) | Clinical Trial Compass
TerminatedPhase 1
Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
United States7 participantsStarted 2012-12-10
Plain-language summary
This pilot clinical trial studies infusion of expanded cord blood hematopoietic progenitor cells following combination chemotherapy in treating younger patients with acute myeloid leukemia that has relapsed or has not responded to treatment. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy also kills healthy infection-fighting cells, increasing the risk of infection. The infusion of expanded cord blood hematopoietic progenitor cells may be able to replace blood-forming cells that were destroyed by chemotherapy. This cellular therapy may decrease the risk of infection following chemotherapy.
Who can participate
Age range
6 Months – 30 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.
Inclusion Criteria:
* Patients must have a diagnosis of AML or acute leukemia of ambiguous lineage according to World Health Organization (WHO) classification with \>= 5% of disease in bone marrow (BM)
* Recipients of prior allogeneic hematopoietic stem cell transplantation for AML or acute leukemia of ambiguous lineage are eligible if they do not have graft-versus-host disease (GVHD) or they have quiescent GVHD whether or not they are receiving immunosuppressive therapy
* Must have a Lansky or Karnofsky performance status of \>= 50; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Patients must have recovered from the acute toxicity of all prior chemotherapy
* The following amounts of time must have elapsed prior to entry on study:
* 2 weeks from local radiation therapy (XRT)
* 8 weeks from prior craniospinal or if \> 50% of the pelvis has been irradiated
* 6 weeks must have elapsed if other bone marrow radiation has occurred
* Adequate cardiac, renal, pulmonary, and hepatic function
* Patient must have a life expectancy of at least 2 months
* Females of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
* Females of childbearing potential and males should agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
Exclusion Criteria:
* Recipients of prior allogeneic hematopoietic…
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
1
Incidence of NCI CTCAE grade > 3 infusional toxicities
Timeframe: Up to 2 years
2
Occurrence of transfusion associated graft versus host disease
Timeframe: Up to 2 years
3
Incidence of platelet refractoriness in the presence of alloimmunization as a direct result of ex vivo expanded cord blood product infusion