Clinical trial · Interventional
S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine | Drug | Fludarabine | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27
- interventionNames
- Biological: therapeutic allogeneic lymphocytes
- Drug: cyclosporine
- Drug: fludarabine
- Drug: mycophenolate mofetil
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 1 year
- description
- measured from date of registration to study until death from any cause with patients still alive censored at date of last contact
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis) OR * Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic therapy) * Must have A1 marrow, B1 blood, and C1 extramedullary disease status * Must have received prior remission induction chemotherapy * Must have a genotypically HLA-identical sibling donor available that is not a monozygotic identical twin * No M3 AML or blastic transformation of chronic myelogenous leukemia * If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7 days * Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910 PATIENT CHARACTERISTICS: Age * 55 to 69 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 2 years except for the following: * Adequately treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * No prior allogeneic hematopoietic stem cell transplantation Chemotherapy * See Disease Characteristics * Prior consolidation therapy allowed Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Prior organ transplantation allowed provided not concurrently receiving immunosuppressive therapy
References
Publications (0)
Data not yet available