Clinical trial · Interventional
Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia
Antibody Therapy With Alemtuzumab, Rituximab and GM-CSF for Initial Treatment of High Risk Chronic Lymphocytic Leukemia
- 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 rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for early-stage chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab together with GM-CSF and to see how well it works in treating patients with early-stage chronic lymphocytic leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Biological | Alemtuzumab | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
| Sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab + Rituximab + GM-CSF
- description
- Alemtuzumab + Rituximab + GM-CSF
- interventionNames
- Biological: Alemtuzumab
- Biological: Rituximab
- Biological: Sargramostim
Primary outcomes (1)
- measure
- Number of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months
- timeFrame
- 6 months
- description
- Response, as defined by the National Cancer Institute Working Group (NCIWG), requires the following for a period of at least 2 months: * CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy * PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100,000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:
* Minimum threshold peripheral blood lymphocyte count 5 x 10\^9/L
* Monoclonality (light chain exclusion) of B lymphocytes detected by immunophenotyping (CD19-positive), demonstrating ≥ 3 of the following characteristics:
* CD5-positive
* CD23-positive
* Dim surface light chain expression
* Dim surface CD20 expression
* Negative for IGH/CCND1 translocation AND/OR immunostaining is negative for cyclin D1 expression by fluorescent in-situ hybridization (FISH) analysis
* Rai stage 0, I, or II disease that does not meet standard NCI-Working Group criteria for treatment of CLL
* Poor prognosis as defined by ≥ 1 of the following factors:
* Unmutated IgVH mutation status AND CD38 expression (i.e., ≥ 30% cells positive on flow cytometry)
* Unmutated IgVH mutation status AND ZAP-70 expression (i.e., ≥ 20% cells positive on flow cytometry)
* VH3-21 gene segment use irrespective of mutation status AND CD38 expression (≥ 30% cells positive on flow cytometry)
* VH3-21 gene segment use irrespective of mutation status AND ZAP-70 expression (≥ 20% cells positive on flow cytometry)
* 11q-negative\*
* 17p-negative\* NOTE: \*Determination of IgVH mutation status is not required in patients whose eligibility is based on 17p13- or 11q22- deletions
PATIENT CHARACTERISTICS:
* ECOG performance status 0- 2
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 ULN
* AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must practice effective contraception
* Willing to provide mandatory blood samples (for patients at the Mayo Clinic in Rochester only) for research studies as required by the protocol
* No comorbid conditions, including any of the following:
* New York Heart Association Class III or IV heart disease
* Myocardial infarction within the past month
* Uncontrolled infection
* HIV infection or AIDS
* Serological evidence of active hepatitis B infection (i.e., serum antigen or e-antigen positivity) or positive hepatitis C serology
* No other active primary malignancy requiring treatment or limiting survival to ≤ 2 years
* No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior major surgery
* No prior chemotherapy or monoclonal antibody treatment for CLL
* No concurrent corticosteroidsReferences
Publications (1)
- DERIVEDZent CS, Wu W, Bowen DA, Hanson CA, Pettinger AM, Shanafelt TD, Kay NE, Leis JF, Call TG. Addition of granulocyte macrophage colony stimulating factor does not improve response to early treatment of high-risk chronic lymphocytic leukemia with alemtuzumab and rituximab. Leuk Lymphoma. 2013 Mar;54(3):476-82. doi: 10.3109/10428194.2012.717276. Epub 2012 Aug 22. PMID 22853816