Clinical trial · Interventional
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
Phase I Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous 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): Drug unavailable
Summary
Brief summary (as posted)
The primary goal of this study is to determine the feasibility and safety of giving two doses of denileukin diftitox (DD) at days 0 and 21 post autologous stem cell transplantation in a dose escalation fashion. Secondary goals include evaluating the the effect of DD on the number and percentage of T-regs in the peripheral blood post transplant at each dose level, the effect of DD on T cell (CD4/CD8) reconstitution post transplant at each dose level and determining the time to engraftment: absolute neutrophil count (\>0.5 x 10\^9/L for 3 consecutive days), and platelet (\>20X 10\^9/L for 3 consecutive days). The hypothesis for the study is based on the ability of DD to deplete T-regs and subsequently enhance the immune reconstitution and reverse post transplant lymphopenia. This may indirectly enhance the efficacy of autologous transplantation and reduce disease relapse.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denileukin Diftitox (Ontak) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Denileukin Diftitox (Ontak)
- description
- Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.
- interventionNames
- Drug: Denileukin Diftitox (Ontak)
Primary outcomes (1)
- measure
- Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.
- timeFrame
- Up to 21 days post transplant
- description
- After drug infusion, participants will be closely monitored for at least 4 hours for side effects
Secondary outcomes (3)
- measure
- To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: All patients age \> =18 who have been diagnosed with Multiple Myeloma and are scheduled for autologous peripheral blood hematopoietic stem cell transplant (AHSCT) will be screened for eligibility. Patients must fulfill all of the following inclusion criteria to be eligible for this study: 1. Diagnosis of Multiple Myeloma 2. Age \>=18 and no more than 70 years. 3. Able to understand and sign a consent form. 4. Can collect peripheral blood stem cells with a CD34+ cell dose of at least 5.0 x 106/kg. The CD34 molecule is a Cluster of Differentiation molecule present on hematopoietic stem cells. 5. Conditioning regimen to be high dose Melphalan at a dose of 200mg/m2. 6. Karnofsky Performance Score (KPS) \>60 or ECOG (Eastern Cooperative Oncology Group) performance status \<=2 7. Kidney function:Creatinine \<2.0 mg/dl or creatinine clearance \>50 ml/min 8. Heart function: Ejection fraction \>45% 9. Liver function tests :Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal 10. Lung function tests: Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1) or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) \>45% predicted Exclusion Criteria: 1. Age \<18 years or \> 70 years 2. Previous exposure to denileukin diftitox. 3. Patients with documented uncontrolled central nervous system (CNS) disease. 4. Previous AHSCT. 5. Significant organ dysfunction deemed to be inappropriate for autologous transplantation.
References
Publications (0)
Data not yet available