Clinical trial · Interventional
AML Therapy With Irradiated Allogeneic Cells
NCT02105116CI-TRIAL-00053460terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients were eligible to receive the experimental component of the protocol therapy.
Summary
Brief summary (as posted)
This pilot clinical trial studies if cells donated by a close genetic relative can help maintain acute myeloid leukemia (AML) complete remission (CR). Eligible patients will receive a standard induction chemotherapy. If a complete remission results they will receive irradiated allogeneic cells from a HLA haploidentical relative. Only patients who obtain a CR after the standard induction chemotherapy are eligible for the experimental therapy (irradiated haploidentical cells).
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Adult Acute Myeloblastic Leukemia Without Maturation (M1) | Adult Acute Myeloid Leukemia without Maturation | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| donor lymphocytes | Biological | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard chemotherapy followed by allogenic therapy
- description
- INDUCTION CHEMOTHERAPY: Patients receive standard induction chemotherapy with fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have \>5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician. If the patient enters a complete remission they are eligible for ALLOGENEIC CELLULAR THERAPY: Patients eligible for the experimental therapy undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10\^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: fludarabine phosphate
- Drug: cytarabine
- Biological: donor lymphocytes
- Other: laboratory biomarker analysis
- Drug: G-CSF
Primary outcomes (3)
- measure
- Adverse Events Related to Experimental Therapy
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven non-M3 AML: * Refractory/relapsed AML OR * Initial diagnosis of AML in patient \>= 60 years old * Total bilirubin =\< 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional ULN * Cardiac left ventricular ejection fraction (LVEF) \>= 35% * Serum creatinine =\< 1.5 mg/dl * Any organ dysfunction thought to be secondary to disease will be considered separately and the patient will be included at the investigators discretion * Patients must give informed consent * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 * Must have a potential haploidentical donor (parent, sibling, child) * A patient is eligible for second enrollment (allo-cellular therapy) if all of the following inclusion criteria are met: * Patient must have documented CR or CRp after 1 or 2 cycles of fludarabine + cytarabine * Patient must not be a candidate for an allo-hematopoietic stem cell transplant (HSCT) * Patient must have a partially (\>= 3/6 class I antigen) human leukocyte antigen (HLA)-matched (by serology or low resolution deoxyribonucleic acid \[DNA\] testing) relative able to serve as a donor * Patients must not have active uncontrolled infections, other medical or psychological/social conditions that might increase the likelihood of patient adverse effects or poor outcomes * Total bilirubin \< 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease) * AST(SGOT)/ALT(SGPT) =\< 2.5 X institutional ULN * Serum creatinine \< 2.0 mg/dl * ECOG performance status =\< 2 * DONOR: donor must be related to patient and be partially (\>= 3/6 antigen) HLA-matched * DONOR: donor must meet all New Brunswick Affiliated Hospitals (NBAH) requirements for hematopoietic stem cell donation, including: * DONOR: age \>= 18 years old * DONOR: white blood cells (WBC) 4.0-10.0 x 10\^3/mm\^3 * DONOR: platelet count 150,000 to 440,000/mm\^3 * DONOR: hemoglobin/hematocrit; 12.5-18 g/dl, 38 to 54% * DONOR: not pregnant or lactating * DONOR: not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C virus (HCV), hepatitis B core or human T-lymphotropic virus (HTLV)-I/II seropositive; hepatitis B surface antigen (HB S ag) (-); meet other infectious disease screening criteria utilized by NBAH Blood Center * DONOR: no uncontrolled infections, other medical or psychological/social conditions, or medications that might increase the likelihood of patient or donor adverse effects or poor outcomes * DONOR: meet other blood bank criteria for blood product donation (as determined by NBAH Blood Center screening history and laboratory studies) Exclusion Criteria: * History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity * Patients with known active central nervous system (CNS) leukemia will be excluded from this clinical study * Known HIV-positive patients are excluded from the study * Patients may not be pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.