Clinical trial · Interventional
Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia
Early Treatment of High Risk Chronic Lymphocytic Leukemia With Alemtuzumab, Rituximab, and PGG Beta-Glucan: A Phase I/II Trial
- 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)
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells. Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with monoclonal antibodies, such as alemtuzumab and rituximab, more effective. PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan when given together with alemtuzumab and rituximab and to see how well it works in treating patients with earlier stage high-risk chronic lymphocytic leukemia.
Conditions
Conditions (5)
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 |
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage 0 Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage I Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage II Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| DNA analysis | Genetic | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| PGG beta-glucan | Drug | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| polymorphism analysis |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31; alemtuzumab subcutaneously on days 3, 4, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; and rituximab IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: alemtuzumab
- Biological: rituximab
- Drug: PGG beta-glucan
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Genetic: DNA analysis
- Genetic: fluorescence in situ hybridization
- Genetic: polymerase chain reaction
- Genetic: polymorphism analysis
- Genetic: mutation analysis
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of PGG Beta Glucan in Combination With Alemtuzumab and Rituximab Assessed by Analyzing the Number of Dose-limiting Toxicity Events (Phase I)
- timeFrame
- First cycle of treatment (35 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CLL (Hallek, Cheson et al. 2008) manifested by: Minimum threshold peripheral lymphocyte count of 5 x 10\^9/L AND immunophenotypic demonstrations of a population of B lymphocytes (as defined by CD19+) which are monoclonal (light chain exclusion); CLL will be diagnosed if these cells have \>= 3 of the following characteristics: CD5+, CD23+, dim surface light chain expression, dim surface CD20 expression AND fluorescence in situ hybridization (FISH) analysis is negative for IGH/CCND1 and/or immunostaining is negative for cyclin D1 expression * \>= 1 of the following poor prognosis factors: unmutated IGHV (\< 2%) AND CD38 expression (\>= 30% cells positive on flow cytometry); unmutated IGHV (\< 2%) AND ZAP-70 expression (\>= 20% cells positive on flow cytometry); use of VH3-21 gene segment irrespective of mutation status AND CD38 expression (\>= 30% cells positive on flow cytometry); use of VH3-21 gene segment irrespective of mutation status AND ZAP-70 expression (\>= 20% cells positive on flow cytometry); 11q22-; 17p13- * Rai classification Stage 0, I or II that does not meet standard NCI-IWCLL criteria for treatment of CLL (Hallek, Cheson et al. 2008) * Limited CLL disease burden with no lymph nodes \> 5 cm in any diameter and splenomegaly \< 6 cm below left costal margin in midclavicular line at rest * Creatinine =\< 1.5 x upper normal limit (UNL) * Total bilirubin =\< 3.0 x UNL; if total is elevated, a direct bilirubin should be performed and should be =\< 1.5 x UNL * AST =\< 3.0 x UNL * Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1, or 2 * Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only * Provide informed written consent * Willing to return to a Lymphoma Specialized Program of Research Excellence (SPORE) enrolling institution for follow-up * Willing to provide blood samples for correlative research purposes Exclusion Criteria: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * New York Heart Association Class III or IV heart disease * Recent myocardial infarction (\< 1 month) * Uncontrolled infection * Infection with the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), serological evidence of active hepatitis B infection (HBsAg or HBeAg positive) or positive hepatitis C serology, as further severe immunosuppression with this regimen may occur * Evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia * Other active primary malignancy requiring treatment or limits survival to =\< 2 years * Any major surgery =\< 4 weeks prior to registration * Any previous chemotherapy or monoclonal antibody treatment for CLL * Current use of corticosteroids; NOTE: previous corticosteroids are allowed
References
Publications (0)
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