Clinical trial · Interventional
T-Cell Depleted Allogeneic Stem Cell Transplantation for 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)
Objectives: 1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. 2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. 3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Anemia, Aplastic | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoid Leukemia | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Malignant Lymphoma | Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative Disorder | Myeloproliferative Neoplasm | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Campath | Drug | Alemtuzumab | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug Intervention
- interventionNames
- Drug: Fludarabine
- Drug: Melphalan
- Drug: Stem cells
- Drug: Campath
Primary outcomes (1)
- measure
- Median Disease-free Survival
- timeFrame
- Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years
- description
- All patients were administered the following drugs; 1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 2. Melphalan 140mg/m2 IV on day -2 3. Stem cell infusion on day 0 4. Campath 20mg IV on day -7,-6,-5,-4, and -3
Secondary outcomes (1)
- measure
- Median Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Zubrod performance status 2 (See Appendix B). * Life expectancy is not severely limited by concomitant illness. * Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. * Serum creatinine \<1.5 mg/dL or Creatinine Clearance \>50 ml/min . * Serum bilirubin 2.0 mg/dl, SGPT \<3 x upper limit of normal * No evidence of chronic active hepatitis or cirrhosis. * HIV-negative * Patient is not pregnant * Patient or guardian able to sign informed consent. Exclusion Criteria: * N/A
References
Publications (0)
Data not yet available