Clinical trial · Interventional
Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic 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)
This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.
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 Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Thymoglobulin | Drug | — | UNRESOLVED |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
| Umbilical Cord Blood | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reduced Intensity Conditioning with UCB Transplant
- interventionNames
- Drug: Fludarabine
- Drug: Busulfan
- Drug: Thymoglobulin
- Radiation: Total Body Irradiation
- Biological: Umbilical Cord Blood
Primary outcomes (1)
- measure
- Event Free Survival
- timeFrame
- 180 days
- description
- Number of subjects surviving with no events at 180 days post transplantation (Day 0).
Secondary outcomes (7)
- measure
- Transplant Engraftment
- timeFrame
- Day 42
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Subjects 18-70 years old. ECOG 0-2 Patients must have a diagnosis of one of the following: * Chronic Myeloid Leukemia * Acute Myeloid Leukemia * Acute Lymphoblastic Leukemia * Hodgkin's Disease * Non-Hodgkins Lymphoma * Myelodysplastic Syndromes * Myeloproliferative Disorder Patients must have adequate visceral organ function * Patients must furnish written informed consent and HIPAA authorization for release of personal health information. * Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Exclusion Criteria: * Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible. * Patients who are pregnant are ineligible. * Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction. Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
References
Publications (0)
Data not yet available