Clinical trial · Interventional
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies
NCT00473551CI-TRIAL-00005956terminatedPhase 1ClinicalTrials.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): Terminated due to slow accrual.
Summary
Brief summary (as posted)
Primary Objective: 1\. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Secondary Objective: 1\. Toxicity, response rate, time to progression and overall survival.
Conditions
Conditions (3)
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 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-third Party Cytolytic T-lymphocytes (CTL) | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| Radiation Treatment | Radiation | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Sirolimus | Drug | Sirolimus | ALIAS |
| Stem Cell Transplantation (SCT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-Third Party T Lymphocytes + Nonmyeloablative SCT
- description
- Anti-Third Party CTL (Cytolytic T-lymphocytes) with Nonmyeloablative SCT (Stem Cell Transplantation) Rituximab 375 mg/m\^2 intravenously over several hours on Day -13, followed by 1000 mg/m\^2 intravenously on Days -6, 1, and 8; + Cyclophosphamide 50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine; + Fludarabine 40 mg/m\^2 intravenously over 30 minutes once per day for 4 days, starting Day -6; + Radiation 2Gy Total body radiation day before transplantation + Stem Cell Transplantation + Intravenous infusion of Anti-third Party CTLs.
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Mesna
- Radiation: Radiation Treatment
- Procedure: Stem Cell Transplantation (SCT)
- Drug: Sirolimus
- Procedure: Anti-third Party Cytolytic T-lymphocytes (CTL)
Primary outcomes (2)
- measure
- Number of Participants achieving engraftment without severe Graft-versus-host disease (GVHD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 * Confirmed diagnosis of follicular lymphoma, mantle cell lymphoma, chronic lymphocyte leukemia/small lymphocytic lymphoma or multiple myeloma. Patients must have had persistent or progressive disease despite initial chemotherapy. Patients must have achieved a partial or complete response to their most recent chemotherapy. * Patients must have an human leukocyte antigen (HLA) matched (HLA-A, B, C DR or DQ) related donor who is seropositive against Epstein Barr virus and capable of donating peripheral blood mononuclear cells and peripheral blood progenitor cells. * Patient must be HLA completely mismatched for HLA class I loci (A, B and C) with the 3rd party stimulator cells. HLA-A (330301, 310102) HLA-B (5801,150101\[62\]) HLA-C (0302, 030301) * Zubrod Performance Scale (PS) of 0 or 1 * Creatinine \< 1.8 mg/dl * Ejection fraction \>/=40% * Corrected Carbon Monoxide Diffusing Capacity (DLCO) \>/=45% predicted * Serum bilirubin \</=1.5 mg/dl if not due to Gilbert's syndrome Exclusion Criteria: * Uncontrolled infection * HIV, hepatitis B surface antigen or hepatitis C seropositive * serum glutamic-pyruvic transaminase (SGPT) \> 200 IU/ml * Pregnant or lactating women i.e., positive Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential. Child bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
References
Publications (0)
Data not yet available
No reference posted for this study.