Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
- 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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7-hydroxystaurosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
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 B-cell small lymphocytic lymphoma (SLL)
* CLL is defined as:
* Persistent lymphocytosis greater than 5,000/mm\^3
* CD19/CD5/CD23 positive
* Kappa or lambda light chain restriction
* Refractory to or disease progression after 1 or 2 prior treatment regimens
* Retreatment with oral chlorambucil is allowed and considered a second regimen
* At least one of the chlorambucil treatments must be for 3 months or longer
* At least 4 courses of cyclophosphamide, vincristine, and prednisone with or without doxorubicin allowed
* Patients may have received prior fludarabine as first- or second-line therapy if there is evidence of at least partial response and time to progression after initial fludarabine therapy was at least 12 months
* No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* More than 3 months
Hematopoietic
* See Disease Characteristics
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* No autoimmune hemolytic anemia or thrombocytopenia secondary to CLL or SLL requiring ongoing therapy with prednisone or other immunosuppressive agents
Hepatic
* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal
Renal
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Pulmonary
* DLCO greater than 60% predicted
* FEV\_1 greater than 70% predicted
* No significant underlying pulmonary disease
Other
* No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No insulin-dependent diabetes mellitus
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No pre-existing peripheral neuropathy grade 2 or greater
* No psychiatric illness or social situation that would preclude study compliance
* No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents in this study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy
* See Hematopoietic
Radiotherapy
* No prior mediastinal radiation
* At least 4 weeks since prior radiotherapy and recovered
Surgery
* Not specified
Other
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patientsReferences
Publications (0)
Data not yet available