Clinical trial · Interventional
A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using Two Related Donors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This phase II clinical trial studies how well two donors stem cell transplant work in treating patients with high-risk hematologic malignancies. After receiving radiation to help further treat the disease, patients receive a dose of donors' T cells. T cells can fight infection and react against cancer cells. Two days after donors' T cells are given, patients receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not destroyed by CY and they remain in the patient to help fight infection. A few days after the CY is given, patients receive donors' stem cells to help their blood counts recover. Using two donors' stem cell transplant instead of one donor may be more effective in treating patients with high-risk disease and may prevent the disease from coming back.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hodgkin's Lymphoma |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (CY) | Drug | Cyclophosphamide | ALIAS |
| Donor Lymphocyte Infusion (DLI) | Biological | — | UNRESOLVED |
| Hematopoietic Stem Cell Transplant (HSCT) | Biological | Hematopoietic Cell Transplantation | ALIAS |
| Mycophenolate Mofetil (MMF) | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total Body Irradiation (TBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic HSCT Using Two Related Donors
- description
- CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28.
- interventionNames
- Radiation: Total Body Irradiation (TBI)
- Biological: Donor Lymphocyte Infusion (DLI)
- Drug: Cyclophosphamide (CY)
- Drug: Tacrolimus
- Drug: Mycophenolate Mofetil (MMF)
- Biological: Hematopoietic Stem Cell Transplant (HSCT)
Primary outcomes (1)
- measure
- One Year Relapse-Free Survival
- timeFrame
- 1 year
- description
- To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors. Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover.
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 (morphological, cytogenetic, molecular, or radiographic) 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 CR. Patients with marrow based diseases in which the marrow biopsy does not meet criteria for active disease (i.e. \<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 two related donors that meet an acceptable scenario as described above. 3. Patients must adequate organ function: * LVEF of \>= 50% * DLCO (adjusted for hemoglobin) \>= 50% of predicted * Adequate liver function as defined by a serum bilirubin =\< 1.8, AST or ALT \< 2.5X upper limit of normal * Creatinine clearance of \>= 60 ml/min 4. Karnofsky Performance Status of \> 80 % on the modified KPS tool (see Appendix A). 5. Patients must be willing to use contraception if they have childbearing potential. 6. Able to give informed consent Exclusion Criteria: 1. Modified KPS of \< 80% 2. \>= 5 Comorbidity Points on the HCT-CI Index (See Appendix B) 3. 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. ATG level of \>= 2 ugm/ml 11. Patients with active inflammatory processes (such as flair of an autoimmune disease) including T max \> 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