Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
NCT00101140CI-TRIAL-00029973withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.
Conditions
Conditions (3)
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 Erythroid Leukemia | Adult Acute Erythroid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Monoblastic and Acute Monocytic Leukemia | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Drug | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| chemotherapy | Procedure | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| non-specific immune-modulator therapy | Procedure | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes: * Acute myeloblastic leukemia (M0, M1, M2) * Acute myelomonocytic leukemia (M4) * Acute monocytic leukemia (M5) * Acute erythroleukemia (M6) * Acute megakaryocytic leukemia (M7) * Must have 1 of the following karyotypic abnormalities at the time of diagnosis: * Complex cytogenetic abnormalities (≥ 3 cytogenetic clones) * Abnormalities of chromosome 5 \[-5 or del(5q)\] * Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21 * Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8) * In morphologic first complete remission\*, as evidenced by all of the following for ≥ 4 weeks before study entry: * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Leukemic blasts not present in the peripheral blood * Cellularity of bone marrow biopsy \> 20% with maturation of all cell lines * Less than 5% blasts by bone marrow biopsy * No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: \*Reduced hemoglobin concentration or hematocrit has no bearing on remission status * Haploidentical (3/6 or 4/6 antigen matched \[A, B, and DR\]) family donor available PATIENT CHARACTERISTICS: Age * 18 to 59 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 2.0 mg/dL * AST \< 2 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * Ejection fraction \> 40% by MUGA or echocardiogram * None of the following within the past 3 months: * Myocardial infarction * Significant congestive heart failure * Significant cardiac arrhythmia Pulmonary * FEV\_1 and DLCO \> 50% of predicted Immunologic * HIV negative * No active or unresolved infection * No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No organ damage * No other medical problem that would preclude study participation * No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.