Clinical trial · Interventional
Trial of Donor Lymphocyte Infusion (DLI) and Activated DLI Following Relapse After Allogeneic Stem Cell Transplant
A Phase I/II Trial Of DLI And Activated DLI (ADLI) Followed By Either Repetitive Dosing Of ADLI Or Dose Escalated ADLI For Patients With Relapse After Allogeneic Stem Cell Transplantation
- 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 funds
Summary
Brief summary (as posted)
This study is for patients with relapsed of disease after allogeneic bone marrow The donor's T cells are activated by exposure to 2 compounds or antibodies that bind (or stick to) two compounds on T cells called CD3 and CD28. When these antibodies stick to both CD3 and CD28 on the T cells, the T cells becomes stimulated (or "activated") and grows. CD3 and CD28 are the coating of a T cell and a T cell is part of the body's immune system. It is believed that when T cells are exposed to both of antibodies to CD3 and CD28 compounds at the same time, they become activated or "stimulated" and may be more effective in fighting infections or cancer cells. We call this therapy "activated donor lymphocyte infusions, or activated DLI (aDLI)". This current study is being performed to see whether it is safe and effective to administer higher doses of activated DLI or repeated doses of activated DLI. All patients will receive standard donor lymphocyte infusions first, and in addition will receive activated donor lymphocytes approximately 12 days later (DLI followed by aDLI). Depending on the response to this treatment, and depending on possible side effects (such as graft-vs-host disease as described below), patients in remission will then receive additional aDLI every 3 months for 4 more times, and patients not in remission within 6-12 weeks will receive higher dose aDLI. The timing of the higher dose aDLI will be determined by your physician depending on your disease and the rate of progression of your disease. The aDLI can be given as early as 6 weeks, or as late as 12 weeks (3 months).
Conditions
Conditions (8)
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| 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 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin's Lymphoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD3/CD28 Activated T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CR
- description
- Subjects who are in CR ater 6-12 weeks after aDLI
- interventionNames
- Biological: CD3/CD28 Activated T cells
- type
- EXPERIMENTAL
- label
- Not in CR
- description
- Subjects not in CR after 6-12 weeks after aDLI
- interventionNames
- Biological: CD3/CD28 Activated T cells
Primary outcomes (1)
- measure
- Determining the incidence and severity of acute and chronic GVHD associated with repetitive dosing of aDLI.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Prior allogeneic stem cell transplant.
* Expected survival \> 4 weeks
* Original bone marrow donor available for leukocyte donation.
* Absence of active acute GVHD \> grade I, or chronic GVHD.
* Off all immune suppression for GVHD for 28 days (an exception may be made for patients with acute leukemia whose disease is progressing rapidly and a 28 day waiting period after discontinuation of immune suppression is not practical or appropriate).
* Creatinine \< 2.5 mg/dl.
* Relapsed or persistent advanced malignancy with less than a 50% chance of responding to unstimulated DLI:
a. CML: Relapse with accelerated phase, or blast phase disease b. AML, ALL i. Cytogenetic relapse (less than 5% blasts).
1. The patient's leukemia-specific chromosome abnormality is detectable by standard cytogenetics in more than 25% of cells at any time greater than day 50 post-transplant.
ii. Hematologic relapse: More than 5% blasts in the marrow or peripheral blood.
c. MDS d. Non-Hodgkin's Lymphoma or Hodgkin's Disease i. Relapse: Recurrent disease by serial physical exam, radiographic studies, or molecular studies. If possible, tumor should be re-biopsied to determine histology and rule out possibility of EBV-related lymphoproliferative disease e. CLL f. Myeloma
Exclusion Criteria:
* Active chronic or acute GVHD \> grade I.
* Requirement for active immunosuppression to treat GVHD.
* Pregnant or lactating women. The safety of this therapy on unborn children or effects on breast milk are not known.
* Uncontrolled active infection
* Any uncontrolled active medical disorder that would preclude participation as outlined.References
Publications (0)
Data not yet available