Clinical trial · Interventional
Peripheral Stem Cell Transplant in Treating Patients With High-Risk Leukemia
Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia
NCT00066417CI-TRIAL-00010178terminatedPhase 2ClinicalTrials.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Why stopped (as posted): Trial was withdrawn for drug availability issues.
Summary
Brief summary (as posted)
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with high-risk leukemia.
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 |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| bone marrow transplantation | Procedure | — | UNRESOLVED |
| chemotherapy | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Incidence of graft failure 100 days post-transplant
- measure
- Incidence of acute and chronic graft-vs-host disease100 days post-transplant
- measure
- Transplant-related mortality 100 days post-transplant
- measure
- Disease-free survival 100 days post-transplant
- measure
- Overall survival 100 days post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* High-risk myelodysplastic syndromes (MDS), meeting 1 of the following criteria:
* Transformation to acute leukemia defined by at least 15% blasts
* Secondary to prior treatment with chemotherapy and/or radiotherapy
* Presence of complex cytogenetics (at least 3 karyotypic abnormalities)
* Monosomy or deletion of chromosome 7
* Acute myeloid leukemia (AML), meeting 1 of the following criteria :
* High-risk AML in first remission and meeting 1 of the following criteria:
* At least 3 karyotypic abnormalities
* Monosomy or deletion of chromosome 5 or 7 = 11q23 chromosomal abnormality
* Prior diagnosis of MDS
* Received prior radiotherapy or chemotherapy
* In second or subsequent remission
* Primary induction failure or partial remission
* Untested or sensitive relapse
* Chronic myelogenous leukemia, meeting 1 of the following criteria:
* Blast crisis
* Accelerated phase disease that has failed prior treatment with imatinib mesylate, defined as a failure to achieve hematologic response after 3 months of standard dose (600 mg/day) therapy or disease progression on therapy
* Myeloproliferative disease
* The following diagnoses are eligible:
* Agnogenic myeloid metaplasia
* Essential thrombocythemia
* Polycythemia vera
* Must have evidence of transformation to acute leukemia
* Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
* High-risk ALL in first remission defined by 1 of the following:
* t(9;22) or 11q23 chromosomal abnormality
* Complete response at least 4 weeks after induction therapy OR requiring at least 2 induction regimens
* Second or subsequent remission
* No relapsed leukemia refractory to appropriate salvage therapy
* Availability of an HLA-mismatched family donor
* Donor age 75 or under
* No better donor alternative (i.e., HLA-matched related or unrelated stem cell donor) is available
PATIENT CHARACTERISTICS:
Age
* 10 to 50
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin no greater than 4 mg/dL
* Transaminases no greater than 3 times upper limit of normal
Renal
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* LVEF at least 40%
Pulmonary
* DLCO at least 65% of predicted
Other
* Not pregnant
* Negative pregnancy test
* HIV negative
* No other prior malignancy except basal cell or squamous cell skin cancer or a remote history of cancer now considered cured
* No major organ dysfunction that would preclude transplantation
* No major anticipated illness or organ failure that would preclude transplantation
* No severe psychiatric illness or mental deficiency that would preclude giving informed consent or complying with study
* No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.