Clinical trial · Interventional
A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
- 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)
This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.
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 |
|---|---|---|---|
| B-Cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MyVax | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The proportion of patients with positive humoral immune responses
- measure
- Safety and toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have signed a written informed consent * B-CLL diagnosis * Rai Stage 0, I, or II * Previously untreated * Be able to watch and wait for approximately 8 months following submission of blood (or tissue) while Id-KLH is being manufactured Exclusion Criteria: * Anti-leukemia treatment prior to beginning immunization * Anti-leukemia treatment other than Id-KLH during immunizations * Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ) * Pregnant or lactating * Patients with known autoimmune disease (including previously treated autoimmune hemolytic anemia or immune thrombocytopenia) * Participation in any other clinical trial in which an investigational agent is administered
References
Publications (0)
Data not yet available