Clinical trial · Interventional
CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
NCT00290472CI-TRIAL-00014687completedPhase 2Results postedClinicalTrials.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)
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Recurrent Adult Burkitt Lymphoma | Adult Burkitt Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Mixed Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks.
- interventionNames
- Drug: temsirolimus
Primary outcomes (3)
- measure
- Objective Overall Response Rate
- timeFrame
- Up to 6 years
- description
- The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
- measure
- Duration of Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the following subtypes:
* Aggressive B-cell lymphoma (Group A)
* Diffuse large B-cell lymphoma
* Transformed lymphoma
* Follicular lymphoma (Group B)
* Small lymphocytic lymphoma
* Chronic lymphocytic leukemia (CLL) (Group C)
* Other B-cell small lymphocytic disorders
* No mantle cell lymphoma
* No potentially curative treatment options because of lack of response, relapse, or ineligibility
* Relapsed or refractory disease
* Patients with refractory disease (i.e., less than a partial response to the last treatment) must have received no more than 3 prior regimens (group A)
* Patients with sensitive disease (i.e., at least a partial response to the last treatment) must have received no more than 4 prior regimens (group A)
* Patients who have failed prior autologous transplantation are eligible (group A)
* No more than 5 prior regimens (groups B and C)
* The salvage regimen, conditioning regimen, and any maintenance therapy are considered 1 regimen
* Prior rituximab or alemtuzumab is not considered prior therapy
* No limitation to the amount of prior radiotherapy
* No CNS involvement
* Performance status: ECOG 0-2 OR Karnofsky 60-100%
* Life expectancy more than 3 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Completed therapy and considered \< 30% risk of relapse
* No other concurrent uncontrolled illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent prophylactic hematopoietic colony-stimulating factors
* No concurrent pegfilgrastim
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* More than 4 weeks since prior radiotherapy and recovered
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum (St. John's wort)
* No other concurrent known inducers of CYP3A4
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* Measurable disease\*
* At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan \[Note: \*Only bone marrow or peripheral blood involvement required for CLL and Waldenstrom's macroglobulinemia \]
* Absolute neutrophil count \>= 1,000/mm3
* Bilirubin =\< 1.5 times upper limit of normal (ULN)
* AST and ALT =\< 2.5 times ULN
* Creatinine =\< 1.5 times ULN
* Fasting cholesterol =\< 350 mg/dL
* Fasting triglycerides =\< 400 mg/dL
* Platelet count \>= 50, 000/mm3 (\> 20,000/mm3 for patients with thrombocytopenia due to bone marrow involvement)References
Publications (1)
- DERIVEDSmith SM, van Besien K, Karrison T, Dancey J, McLaughlin P, Younes A, Smith S, Stiff P, Lester E, Modi S, Doyle LA, Vokes EE, Pro B. Temsirolimus has activity in non-mantle cell non-Hodgkin's lymphoma subtypes: The University of Chicago phase II consortium. J Clin Oncol. 2010 Nov 1;28(31):4740-6. doi: 10.1200/JCO.2010.29.2813. Epub 2010 Sep 13. PMID 20837940