Clinical trial · Interventional
Non-Myeloablative HLA-Matched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
NCT00113828CI-TRIAL-00032098terminatedPhase 2ClinicalTrials.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): Insufficient accrual
Summary
Brief summary (as posted)
The purpose of this trial is to determine if patients with hematologic diseases who have a HLA 6/6 matched related donor and are not eligible for a standard myeloablative stem cell transplant will have less severe graft versus host disease (GVHD), transplant related mortality, and less graft failure when treated with a non-myeloablative T-cell depleted stem cell transplant.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant | Procedure | — | UNRESOLVED |
| T-cell depleted peripheral blood stem cell transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplantation
- description
- T-cell depleted HLA-matched peripheral blood stem cell transplantation
- interventionNames
- Procedure: Non-myeloablative Ex-Vivo T-cell Depleted PBSC Transplant
- Procedure: T-cell depleted peripheral blood stem cell transplant
Primary outcomes (1)
- measure
- To evaluate the risks of severe (grade III/IV) GVHD or transplant related mortality at < 100 days following HLA-matched non-myeloablative stem cell transplantation (or following "prophylactic" DLI given for chimerism conversion).
- timeFrame
- 100 days
Secondary outcomes (3)
- measure
- To evaluate the incidence of acute and chronic GVHD.
- timeFrame
- indefinite
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Disease statue: NHL, HD, or MM that are chemorefractory or relapsed; CLL that is Rai Stage III/IV, or lymphocyte doubling time of 6 months, or stage I/II that is resistant to \> 2 chemotherapy regimens; AML or ALL in 1st or subsequent remission with poor prognostic features; CML in accelerated or blast phae; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematologic disorders which allogeneic stem cell transplantation is appropriate where the risk of conventional transplantation is considered to be unacceptably high. * Estimated disease-free survival of less than one year * ECOG performance status of 0, 1, or 2 * HLA-genotypically or phenotypically matched (at A, B, DR loci) related donor Exclusion Criteria: * Patients who life expectancy is limited by diseases other than their hematologic malignancy. * Cardiac Disease: symptomatic congestive hearth failure, or RVG, or ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension. * Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or DLCO of \< 50%. * Renal Disease: serum creatinine \> 2.0 mg/dl or creatinine clearance \< 50 ml/min. * Hepatic Disease: serum bilirubin \> 2.0 mg/dl or alkaline phosphatase, SGOT or SGPT \> 3 times normal. * Neurologic Disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation * HIV or HTLV I antibody or Hepatitis B surface antigen positivity * Uncontrolled infection
References
Publications (0)
Data not yet available
No reference posted for this study.