Clinical trial · Interventional
Cord Blood Transplantation for Patients With Cancer
Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies
NCT01359254CI-TRIAL-00017716terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): did not accrue enough patients.
Summary
Brief summary (as posted)
The primary objective of this study is to assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific antibodies and in those with active disease.
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 |
|---|---|---|---|
| Hematological Disease | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antithymocyte Globulin (ATG) | Drug | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Total Body Irradiation (TBI) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conditioning Regimen I
- description
- Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
- interventionNames
- Drug: Melphalan
- Drug: Fludarabine
- Drug: Antithymocyte Globulin (ATG)
- type
- EXPERIMENTAL
- label
- Conditioning Regimen II
- description
- Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
- interventionNames
- Drug: Fludarabine
- Drug: Antithymocyte Globulin (ATG)
- Drug: Busulfan
- Drug: Total Body Irradiation (TBI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory acute leukemia (myeloid or lymphoid) * Acute leukemia in first remission at high-risk for recurrence * Chronic myelogenous leukemia in accelerated phase or blast-crisis * Chronic myelogenous leukemia in chronic phase * Recurrent or refractory malignant lymphoma or Hodgkin lymphoma * Chronic lymphocytic leukemia, relapsed or with poor prognostic features * Multiple myeloma * Myelodysplastic syndrome * Chronic myeloproliferative disease * Hemoglobinopathies * Aplastic anemia Exclusion Criteria: * Zubrod performance status \> 2 * Life expectancy is severely limited by concomitant illness * Patients with severely decreased LVEF or impaired pulmonary function tests * Estimated Creatinine Clearance \<50 ml/min * Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal * Evidence of chronic active hepatitis or cirrhosis * HIV-positive * Patient is pregnant * Patient or guardian not able to sign informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.