Clinical trial · Interventional
A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies
NCT01315132CI-TRIAL-00105953completedPhase 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)
This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Matched Sibling Allogeneic Transplantation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic Transplantation
- description
- Matched Sibling Allogeneic Transplantation
- interventionNames
- Device: Matched Sibling Allogeneic Transplantation
Primary outcomes (1)
- measure
- Number of Patients With Overall Survival
- timeFrame
- 1 Year after transplant
- description
- The primary objective of this prospective, phase II trial was to obtain an OS rate of \>60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The \>60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.
Secondary outcomes (1)
- measure
- Graft Versus Host Disease (GVHD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following: 1. Age \> 50 years 2. ECOG Performance status of \<2 3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL 4. CML 2nd chronic phase, accelerated phase, or blastic phase 5. MDS with IPS of Intermediate 2 or greater 6. Any myeloproliferative disorder 7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure 8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT 9. Other conditions not listed will be assessed as high-risk by the PI 2. Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci. 3. Patients must adequate organ function: 1. LVEF of \>45% 2. DLCO (adjusted for hemoglobin) \>45% of predicted 3. Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal 4. Creatinine clearance of \> 60 ml/min 4. Patients must be willing to use contraception if they have childbearing potential 5. Able to give informed consent Exclusion Criteria: 1. ECOG performance status of 3 or 4. 2. HIV positive 3. Active involvement of the central nervous system with malignancy 4. Psychiatric disorder that would preclude patients from signing an informed consent 5. Pregnancy 6. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder.
References
Publications (0)
Data not yet available
No reference posted for this study.