Clinical trial · Interventional
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Human Leukocyte Antigen Partially-Matched Related Donor
NCT01341301CI-TRIAL-00089139completedPhase 2Results postedClinicalTrials.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 this research study is to examine the survival of patients undergoing partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment approach, which has been developed specifically for patients who have evidence of their disease at the time of transplant. In this research study, a way of strengthening the response of the donor cells against the disease has been developed. Patients will undergo one additional day between the two steps of the transplant which may allow their donor's cells to fight the disease more effectively.
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 |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Donor Lymphocyte Infusion (DLI) | Biological | — | UNRESOLVED |
| Laboratory biomarker analysis | Other | — | UNRESOLVED |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic HSCT
- description
- CONDITIONING: Patients undergo Total Body Irradiation (TBI) twice daily (BID) on days -10 to -7. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients receive DLI on day -6 and undergo cluster of differentiation 34 (CD34+) selected allogeneic HSCT on day 0 GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO on days -1 with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID or PO on days -1 to 28.
- interventionNames
- Radiation: Total Body Irradiation
- Biological: Donor Lymphocyte Infusion (DLI)
- Drug: Cyclophosphamide
- Drug: Tacrolimus
- Drug: Mycophenolate mofetil
- Procedure: Allogeneic hematopoietic stem cell transplantation
- Other: Laboratory biomarker analysis
Primary outcomes (1)
- measure
- Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT)
- timeFrame
- 1 year after undergoing hematopoietic stem cell transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Any patient with a hematologic malignancy with residual disease after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely or who is in 3rd or greater complete remission (CR). Patients with marrow based diseases in which the marrow biopsy does not meet criteria for active disease (ie \<5% blasts in acute leukemia) but who does not have full count recovery will be eligible for treatment on this high risk trial. 2. Patients must have at least one related donor who is HLA mismatched in the GVHD direction at two or more HLA loci. 3. Patients must adequate organ function: 1. Left ventricular ejection fraction (LVEF) of \>50 % 2. Diffusion capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) \>50 % of predicted 3. Adequate liver function as defined by a serum bilirubin \<1.8, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 times upper limit of normal 4. Creatinine clearance of \> 60 ml/min 4. Karnofsky Performance Status of \> 80% on the modified KPS tool 5. Patients must be willing to use contraception if they have childbearing potential. 6. Able to give informed consent Exclusion Criteria: 1. Modified Karnofsky performance status (KPS) of \<80% 2. \> 5 Comorbidity Points on the hematopoietic cell transplantation comorbidity index (HCT-CI) Index 3. Untreated class I or II antibodies against donor HLA antigens 4. HIV positive 5. Active involvement of the central nervous system with malignancy 6. Psychiatric disorder that would preclude patients from signing an informed consent 7. Pregnancy, or unwillingness to use contraception if they have child bearing potential 8. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder 9. Alemtuzumab treatment within 8 weeks of HSCT admission. 10. Anti-thymocyte globulin (ATG) level of \> 2 ugm/ml 11. Patients with active inflammatory processes including Tmax \>101 or active tissue inflammation are excluded 12. Inability to tolerate cyclophosphamide or undergo total body irradiation at the doses specified in the treatment plan
References
Publications (0)
Data not yet available
No reference posted for this study.