Clinical trial · Interventional
Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) With Pentostatin, Alemtuzumab, and Low Dose Rituximab: A Phase II Clinical 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: Drugs used in chemotherapy, such as pentostatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab and rituximab, 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. Giving pentostatin together with alemtuzumab and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving pentostatin together with alemtuzumab and rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| pentostatin | Drug | Pentostatin | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| sargramostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Pentostatin, Alemtuzumab, Rituximab)
- description
- Course 1: Patients receive: * 2 mg/m\^2 pentostatin IV on days 8 and 22; * 3 mg alemtuzumab subcutaneously (SC) on day 3; * 10 mg alemtuzumab SC on day 4; * 30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; * 20 mg/m\^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; * 6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2. Courses 2 and 3: Patients receive: * 2 mg/m\^2 pentostatin IV on days 1 and 15; * 30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26; * 20 mg/m\^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26; * 6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3).
- interventionNames
- Biological: alemtuzumab
- Biological: rituximab
- Drug: pentostatin
- Drug: sargramostim
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) meeting the following criteria:
* Minimum threshold peripheral blood lymphocyte count of 5 x 10\^9/L (CLL variant) OR adenopathy \> 1 cm or palpable splenomegaly (SLL variant)
* Immunophenotypic demonstrations of a population of B lymphocytes (as defined by CD19+) that are monoclonal (by light chain exclusion) AND have ≥ 3 of the following characteristics:
* CD5+
* CD23+
* Dim surface light chain expression
* Dim surface CD20 expression
* FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative for cyclin D1 expression
* Must have progressive disease as indicated by any of the following characteristics (based on standard criteria for treatment):
* Symptomatic CLL characterized by any of the following:
* Weight loss \> 10% within the past 6 months
* Extreme fatigue
* Fevers \> 38.5° C (not due to infection)
* Drenching night sweats without evidence of infection
* Evidence of progressive bone marrow failure with hemoglobin \< 11 g/dL or platelet count \< 100 x 10\^9/L
* Massive and progressive splenomegaly (\> 6 cm below left costal margin)
* Massive (\> 10 cm) or rapidly progressive lymphadenopathy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Creatinine ≤ 2 times upper limit of normal (ULN)
* Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN
* AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)
* Willing to provide mandatory blood samples for research studies
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 12 months after completion of study treatment
* No other active primary malignancy that requires treatment or limits survival to ≤ 2 years
* No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
* No New York Heart Association class III or IV heart disease
* No myocardial infarction within the past month
* No uncontrolled infection
* No HIV infection or AIDS
* No active hepatitis B infection (i.e., HBsAg or HBeAg positivity) or hepatitis C infection by serology
* No other comorbid condition
PRIOR CONCURRENT THERAPY:
* No more than 3 prior treatment regimens for CLL that included purine analogue drugs (e.g., fludarabine, pentostatin, or cladribine) OR previously untreated CLL in patients with high-risk disease due to 17p13 deletion on FISH analysis
* More than 4 weeks since prior major surgery
* More than 2 months since prior alemtuzumab
* Prior corticosteroids allowed
* No concurrent continuous systemic corticosteroidsReferences
Publications (1)
- DERIVEDZent CS, Taylor RP, Lindorfer MA, Beum PV, LaPlant B, Wu W, Call TG, Bowen DA, Conte MJ, Frederick LA, Link BK, Blackwell SE, Veeramani S, Baig NA, Viswanatha DS, Weiner GJ, Witzig TE. Chemoimmunotherapy for relapsed/refractory and progressive 17p13-deleted chronic lymphocytic leukemia (CLL) combining pentostatin, alemtuzumab, and low-dose rituximab is effective and tolerable and limits loss of CD20 expression by circulating CLL cells. Am J Hematol. 2014 Jul;89(7):757-65. doi: 10.1002/ajh.23737. Epub 2014 Apr 26. PMID 24723493