What's the purpose of this trial?
The purpose of this study is to determine the overall safety of adoptive immunotherapy when given after chemotherapy for AML/MDS. Adoptive immunotherapy means using an infusion of cells from a donor to help fight cancer. The donor cells will be either from the umbilical cord blood (UCB) of a newborn baby or they will be cells collected from a relative (haplo-identical cells).
The 2 cohorts that were discussed - adoptive immunotherapy with either UCB or haplo-identical stem cells - will be analyzed separately.
Preliminary data from other centers has suggested that adoptive immunotherapy with cells from a relative is an effective approach that may improve remission rates and survival in AML and MDS, because they exert anti-cancer effects of their own (so called graft vs leukemia effects) and possibly because they hasten recovery of cell counts from chemotherapy. The Investigators are interested in confirming these data, but also in testing umbilical cord blood cells for the same purpose. Preliminary data indicate that umbilical cord blood cells may have more powerful graft vs leukemia effects and cause fewer side-effects.
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
Inclusion Criteria:
1. Patients must be 18 years of age or older
2. Patients with a confirmed diagnosis of AML or MDS, according to World Health Organization (WHO) classification (excluding acute promyelocytic leukaemia) with recurrent or refractory disease as defined below.
1. For AML:
1. Primary induction failure (PIF) after ≥ 2 cycles of chemotherapy.
2. First relapse.
3. Relapse refractory to salvage chemotherapy
4. Second or subsequent relapse.
2. For MDS, either refractory anemia with excess blasts (RAEB) I or RAEB II who failed at least one chemotherapy regimen including either cytarabine or a hypomethylating agent.
3. Patients must have Karnofsky Performance score of ≥70
4. Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
5. Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
Exclusion Criteria:
1. Persistent clinically significant toxicities from previous chemotherapy
2. Known positive status for human immunodeficiency virus (HIV)
3. Pregnant and nursing patients
4. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
5. Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
6. Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any New York Heart Association (NYHA) grade 3 or 4.
7. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Additional Trial Information
Phase 2
Enrollment: 90 patients (estimated)
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