Trials / Terminated
TerminatedNCT01801046
Donor Stem Cell Transplant in Treating Patients With High Risk Acute Myeloid Leukemia
HLA-mismatched Allogeneic Cellular Therapy (HMMACT) After Chemotherapy in High Risk Acute Myeloid Leukemia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects of donor stem cell transplant in treating patients with high risk acute myeloid leukemia. Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect)
Detailed description
PRIMARY OBJECTIVES: I. To assess the feasibility of cytarabine based chemotherapy and human leukocyte antigen (HLA)-mismatched allogeneic cellular therapy (HMMACT) in patients with high risk acute myeloid leukemia (AML), with feasibility measured by induction mortality (IM) and complete response rate. SECONDARY OBJECTIVES: I. To obtain preliminary estimates of clinical outcome following cytarabine based chemotherapy and HMMACT in patients with high risk AML, as measured by event free survival (EFS) and overall survival (OS). II. To further evaluate the safety outcomes of induction and consolidation of cytarabine and HMMACT in terms of serious infections (grade 4), time to recovery of absolute neutrophil counts and platelets and incidence of graft versus host disease (GvHD). III. To further evaluate the feasibility of this approach in terms of identifying a suitable donor in this elderly population. IV. To compare in preliminary manner the clinical outcomes of cytarabine and HMMACT in patients with high risk AML as measured by complete response rate (CRR), event free survival (EFS) and overall survival (OS) by donor/recipient HLA-C1 vs C2 pairs. V. To characterize in a preliminary manner, the numbers of suppressor regulatory T cells (Tregs), T helper 17 cells (Th17), and cytotoxic T cells during pre and post HMMACT treatment, and with clinical outcomes in leukemia. OUTLINE: INDUCTION CHEMOTHERAPY: Patients receive mitoxantrone hydrochloride intravenously (IV) on days 1-3 and cytarabine IV on days 1-7. HMMACT: Patients receive filgrastim (G-CSF) mobilized peripheral blood stem cells (G-PBSC) on day 9. After completion of study treatment, patients are followed up monthly for 3 years.
Conditions
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Monoblastic Leukemia (M5a)
- Adult Acute Monocytic Leukemia (M5b)
- Adult Acute Myeloblastic Leukemia With Maturation (M2)
- Adult Acute Myeloblastic Leukemia Without Maturation (M1)
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Acute Myelomonocytic Leukemia (M4)
- Adult Erythroleukemia (M6a)
- Adult Pure Erythroid Leukemia (M6b)
- Childhood Acute Erythroleukemia (M6)
- Childhood Acute Megakaryocytic Leukemia (M7)
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloblastic Leukemia With Maturation (M2)
- Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Acute Myelomonocytic Leukemia (M4)
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Untreated Adult Acute Myeloid Leukemia
- Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mitoxantrone hydrochloride | Given IV |
| DRUG | cytarabine | Given IV |
| PROCEDURE | peripheral blood stem cell transplantation | Undergo HMMACT with G-PBSC |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2013-03-06
- Primary completion
- 2017-07-27
- Completion
- 2017-08-20
- First posted
- 2013-02-28
- Last updated
- 2018-03-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01801046. Inclusion in this directory is not an endorsement.