Clinical trial · Interventional
UCN-01 and Fludarabine in Treating Patients With Recurrent or Refractory Lymphoma or Leukemia
Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies
NCT00019838CI-TRIAL-00017694completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 work in different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given with UCN-01 in treating patients with recurrent or refractory low-grade lymphoma or leukemia.
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 confirmed recurrent or refractory low-grade or indolent lymphoid malignancies requiring systemic therapy, including the following: * Grade I or II follicular small cleaved cell lymphoma * Small lymphocytic lymphoma/leukemia subtypes (chronic lymphocytic leukemia) * Mantle cell lymphoma * Waldenstrom's macroglobulinemia * Lymphoplasmacytoid * Marginal zone (nodal, extranodal, or splenic subtypes) * Hairy cell leukemia * Transformed indolent subtypes allowed provided 1 of the following criteria are met: * Previously treated with a doxorubicin-containing regimen * No rapidly progressing disease that threatens vital functions * Measurable disease * No active leptomeningeal or parenchymal CNS lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 50,000/mm\^3 * No active Coomb's-positive hemolytic anemia Hepatic: * Total bilirubin less than 2.0 mg/dL (unless elevation is due to Gilbert's disease and direct bilirubin is normal) Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No angina * No congestive heart failure * No myocardial infarction within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No insulin-dependent diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * More than 3 weeks since prior systemic chemotherapy and recovered Endocrine therapy: * More than 3 weeks since prior systemic steroid therapy and recovered Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (2)
- RESULTMarti GE, Stetler-Stevenson M, Grant ND, White T, Figg WD, Tohnya T, Jaffe ES, Dunleavy K, Janik JE, Steinberg SM, Wilson WH. Phase I trial of 7-hydroxystaurosporine and fludararbine phosphate: in vivo evidence of 7-hydroxystaurosporine induced apoptosis in chronic lymphocytic leukemia. Leuk Lymphoma. 2011 Dec;52(12):2284-92. doi: 10.3109/10428194.2011.589547. Epub 2011 Jul 12. PMID 21745173
- RESULTWilson WH, Gutierrez M, Stetler-Stevenson M, et al.: Phase I trial of 7-hydroxystaurosporine (UCN-01) and fludararbine phosphate (FAMP); in vivo evidence of UCN-01 induced apoptosis in CLL. [Abstract] Blood 96 (11 Pt 1): A-3268, 756a, 2000.