Clinical trial · Interventional
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkin's Lymphoma
NCT00033267CI-TRIAL-00014176completedPhase 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)
Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
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 |
|---|---|---|---|
| Recurrent Mantle Cell Lymphoma | Mantle Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- 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 with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with CR receive 2 additional courses beyond CR.
- interventionNames
- Drug: temsirolimus
Primary outcomes (1)
- measure
- Proportion of patients who achieve a confirmed CR or PR during the first 24 weeks of treatment defined by the International Workshop criteria
- timeFrame
- Up to 24 weeks
- description
- The proportion will be evaluated separately for each dose group. The proportion of patients who achieve a confirmed CR or PR, or success, will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL)
* Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy
* Unidimensionally measurable lymph node or lesion
* At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam
* One of the following measurement parameters may be used:
* Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin
* Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm\^3
* No known CNS involvement (parenchymal mass or leptomeningeal involvement)
* Performance status - ECOG 0-2
* At least 3 months
* See Disease Characteristics
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Direct bilirubin ≤ 1.5 times ULN
* AST ≤ 3 times ULN (5 times ULN if liver metastases are present)
* Creatinine ≤ 2 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Cholesterol ≤ 350 mg/dL
* Triglycerides ≤ 400 mg/dL
* HIV negative
* No other active malignancy requiring treatment or that would preclude study participation
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* See Disease Characteristics
* Prior high-dose therapy with stem cell transplantation allowed
* At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers
* See Disease Characteristics
* See Biologic therapy
* At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No other concurrent chemotherapy for MCL
* Concurrent corticosteroids for adrenal insufficiency allowed
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No concurrent radiotherapy for MCL
* Any number of prior treatments allowed
* No other concurrent investigational or commercial agents for MCL
* No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide)
* No concurrent immunosuppressive therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.