Clinical trial · Interventional
Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study
NCT00052416CI-TRIAL-00011097completedPhase 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: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thalidomide | Drug | Thalidomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed indolent lymphoma or leukemia of one of the following subtypes: * Chronic lymphocytic leukemia * Follicular center lymphoma (grade I or II) * Lymphoplasmacytic lymphoma * Marginal zone lymphoma (nodal, extranodal, or splenic) * Small lymphocytic lymphoma * Waldenstrom's macroglobulinemia * Any stage of disease allowed * No hairy cell leukemia * No T-cell lymphomas * No prior treatment for lymphoma/leukemia * Considered appropriate for expectant management * Must not require cytotoxic therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin greater than 10.0 g/dL * Platelet count greater than 75,000/mm\^3 Hepatic * Bilirubin no greater than 2 times normal * AST and ALT no greater than 2 times normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No uncontrolled congestive heart failure * No New York Heart Association class III or IV heart disease * No unstable coronary artery disease * No myocardial infarction in the past 6 months * No serious or uncontrolled arrhythmias * No history of thromboembolic disease Pulmonary * No asthma or chronic obstructive pulmonary disease requiring the use of home oxygen or frequent oral steroids (prednisone greater than 20 mg per day for 5 days within the past 3 months) Other * HIV negative * Not pregnant or nursing * Negative pregnancy test * Not planning to become pregnant in the next 2 years * Fertile female patients must use 1 highly effective method and 1 additional effective method of contraception for 1 month prior to, during, and for 1 month after study participation * Male patients must use effective barrier contraception during and for 1 month after study participation * Willing and able to participate in the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) program * No contraindications to meeting the requirements of the S.T.E.P.S. program * No other prior malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy * No poorly controlled diabetes defined by either of the following: * Glycosylated hemoglobin greater than 8.0 g/dL * Known end organ disease (i.e., nephropathy, retinopathy, or neuropathy) * No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.