Clinical trial · Interventional
Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Pentostatin, Cyclophosphamide And Rituximab (PCR) For B-Cell Chronic Lymphocytic Leukemia (CLL) And Small B-Cell Lymphocytic Lymphoma (SLL): Four Phase II Trials With Patient Stratification Based On Prior Therapy
- 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 use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and cyclophosphamide with rituximab in treating patients who have chronic lymphocytic leukemia or lymphocytic lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| pentostatin | Drug | Pentostatin | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small B-cell lymphocytic lymphoma (SLL) with the following:
* Lymph node biopsy interpreted as SLL or consistent with CLL or all of the following:
* Peripheral lymphocyte count greater than 5,000/mm\^3 with small to moderate peripheral lymphocytes and no more than 55% prolymphocytes
* Bone marrow aspirate containing at least 30% lymphoid cells
* Immunophenotypic evaluation of peripheral blood lymphocytes demonstrating monoclonality of B lymphocytes with all of the following:
* CD19 or CD20 coexpressed with CD5 antigen in the absence of other pan-T- cell markers (e.g., CD2 or CD3)
* Expression of CD23 on CLL cells or Dim B-cell expression of kappa or lambda light chains
* Measurable disease with any of the following:
* 1 or more lymph nodes at least 1.5 cm by CT scan
* Splenomegaly by CT scan
* Peripheral lymphocyte count greater than 5,000/mm3 with coexpression of CD5 and B-cell markers
* Bone marrow aspirate with at least 30% lymphoid cells
* No mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 2 years
Hematopoietic
* See Disease Characteristics
* No immune thrombocytopenia
* No hemolytic anemia
Hepatic
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN (unless due to hemolysis or CLL)
* No hepatitis
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No cardiac dysfunction
* No New York Heart Association class III or IV heart disease
* No myocardial infarction within the past month
Other
* HIV negative
* No active acute or chronic infection
* No immunosuppressive diseases
* No autoimmune disorder
* No secondary malignancy that is projected to limit life expectancy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Chemotherapy
* No prior rituximab
* At least 4 weeks since prior biologic therapy
Chemotherapy
* At least 4 weeks since prior chemotherapy
* No prior combination chemotherapy and rituximab or other antibody therapy
* No prior combination chemotherapy comprising an alkylating agent and a purine nucleoside analog (i.e., cyclophosphamide or chlorambucil in combination with fludarabine, cladribine, or pentostatin)
* No prior pentostatin
Endocrine therapy
* At least 4 weeks since prior corticosteroids
* No concurrent supra-physiologic doses of corticosteroids
Radiotherapy
* At least 4 weeks since prior radiotherapy
Surgery
* At least 4 weeks since prior major surgery
Other
* No concurrent immunosuppressive therapy (e.g., cyclosporine)References
Publications (0)
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