Clinical trial · Observational
Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)
Allogeneic Peripheral Blood Stem Cell Transplantation for Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First or Second Remission or Chronic Myelogenous Leukemia in First and Second Chronic Phase or Accelerated Phase
NCT00185523CI-TRIAL-00022605terminatedClinicalTrials.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)
The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.
Conditions
Conditions (7)
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 |
| Leukemia Acute Lymphoid Leukemia (ALL) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| Leukemia Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Leukemia Acute Promyelocytic Leukemia (APL) | Acute Promyelocytic Leukemia | ALIAS | 0.85 |
| Leukemia Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.85 |
| Leukemia Chronic Myelogenous Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
| Leukemia, Lymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CML in first Chronic Phase or Accelerated Phase
- description
- Busulfan/cyclophosphamide Day -7: Busulfan 1.0 mg/kg IV q6 hrs\*\* Day -6: Busulfan 1.0 mg/kg IV q6 hrs Day -5: Busulfan 1.0 mg/kg IV q6 hrs Day -4: Busulfan 1.0 mg/kg IV q6 hrs Day -3: Cyclophosphamide 60 mg/kg Day -2: Cyclophosphamide 60 mg/kg Day -1: rest Day 0: Allogeneic PBSC infusion
- interventionNames
- Procedure: Allogeneic hematopoietic cell transplantation
- label
- AML and ALL in first or second remission
- description
- FTBI/VP-16 Day -7: FTBI 120 cGy x 3 fractions Day -6: FTBI 120 cGy x 2 fractions Day -5: FTBI 120 cGy x 3 fractions Day -4: FTBI 120 cGy x 3 fractions\* Day -3: VP-16 at 60 mg/kg Day -2: rest Day -1: rest Day 0: Allogeneic PBSC infusion
- interventionNames
- Procedure: Allogeneic hematopoietic cell transplantation
Primary outcomes (1)
- measure
- To evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stemcells from their donors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Weeks
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria:1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include: 1. acute myelogenous leukemia, 1st or 2nd remission 2. acute lymphoblastic leukemia, 1st or 2nd remission 3. chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age \> 1 month and \< 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows: a. total bilirubin \<2.5 and SGOT/SGPT \<2x normal b. adequate renal function as defined by creatinine \< 1.5 or a 24 hr creatinine clearance \>50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine \> 1.5) c. DLCO \> 60% predicted d. radionuclide cardiac scan with ejection fraction \>45% 5. Patient must be competent to give consent. Inclusion criteria (Donor): 1. HLA identical family member 2. Donor or guardian must be competent to give consent 3. Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter Exclusion Criteria:3.2 Exclusion Criteria (Patient): 1. Evidence of active infection or active hepatitis 2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+ 3. Previous allogeneic stem cell/bone marrow transplant 4. Pregnant or lactating patients 4 Exclusion criteria (Donor): 1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest 2. Donors who are HIV+ or hepatitis B antigen + 3. History of allergic reaction to G-CSF 4. Female donors must be post-menopausal or have a negative pregnancy test
References
Publications (0)
Data not yet available
No reference posted for this study.