Clinical trial · Interventional
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
- 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)
Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed. Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect. The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.
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 |
|---|---|---|---|
| Relapsed and Refractory Acute Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Double matched sibling transplantation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Double matched sibling transplantation
- description
- Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient. Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.
- interventionNames
- Biological: Double matched sibling transplantation
Primary outcomes (1)
- measure
- Acute graft versus host disease rate,severity and response to treatment
- timeFrame
- 100 days
Secondary outcomes (1)
- measure
- relapse rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older 2. Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning. 3. Patients with refractory or relapsed acute leukemia able to receive myeloablative conditioning but with the following factors: AML- 2 or more of the following: duration of CR1 \< 6 months, poor cytogenetics, circulating blasts, karnofsky \< 90. ALL- age \> 40 or second and additional relapse, or 2 or more of the following: BM blasts \> 25%, age 18-39,first refractory relapse, donor CMV positive. 4. Patients with 2 matched siblings and donor age \> 18 years old. 5. Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation. 6. Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation. Exclusion Criteria: 1. Patient age \< 18 years. 2. Donor age \< 18 years. 3. Patients in remission or not fulfilling above disease criteria -
References
Publications (0)
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