Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
A Phase II Study of Sequential Doxorubicin and Topotecan (Dox/Topo) in Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma (NHL)
NCT00006125CI-TRIAL-00023083completedPhase 2ClinicalTrials.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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and topotecan in treating patients who have relapsed or refractory intermediate-grade or high-grade non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxorubicin + topotecan
- description
- Patients receive doxorubicin IV over 5-10 minutes on day 1 and topotecan IV over 30 minutes on days 3-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years and annually for the next 3 years.
- interventionNames
- Drug: doxorubicin hydrochloride
- Drug: topotecan hydrochloride
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 5 years
Secondary outcomes (1)
- measure
- Time to progression
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma of one of the following subtypes: * Follicular center lymphoma, grade 3 * Diffuse large B-cell lymphoma * Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma * Burkitt's lymphoma * High grade B-cell lymphoma, Burkitt-like * Anaplastic large cell lymphoma, CD30+ cell type * Anaplastic large cell lymphoma, T-cell type * Anaplastic large cell lymphoma, null-cell type * Anaplastic large cell lymphoma, Hodgkin's like * Bidimensionally measurable disease 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: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL history of Gilbert's Disease * AST no greater than 2.5 times upper limit of normal Renal: * Creatinine normal Cardiovascular: * LVEF at least 45% by MUGA or echocardiogram Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Greater than 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) * No greater than 96 mg/m2 mitoxantrone * No greater than 400 mg/m2 prior doxorubicin or combined total doxorubicin and mitoxantrone * No prior camptothecins * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except steroids for adrenal failure or hormones given for nondisease conditions (e.g., insulin for diabetes) * No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: * Greater than 3 weeks since prior radiotherapy * No concurrent radiotherapy except whole brain irradiation for documented CNS disease Surgery: * Not specified
References
Publications (2)
- RESULTSmith SM, Johnson JL, Niedzwiecki D, Eder JP, Canellos G, Cheson BD, Bartlett NL; Cancer and Leukemia Group B. Sequential doxorubicin and topotecan in relapsed/refractory aggressive non-Hodgkin's lymphoma: results of CALGB 59906. Leuk Lymphoma. 2006 Aug;47(8):1511-7. doi: 10.1080/10428190600581385. PMID 16966261
- RESULTSmith SM, Johnson JL, Niedzwiecki D, et al.: Sequential topoisomerase I (topo I) and topoisomerase II (topo II) inhibitors in relapsed/refractory aggressive NHL: results of CALGB 59906, a phase II study of doxorubicin and topotecan. [Abstract] Blood 104 (11): A-2500, 2004.