Phase 2
Completed N=89
CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT00290472 ↗Enrolled (actual)
89
Serious AEs
23.6%
Results posted
Feb 2014
Primary outcomePrimary: Objective Overall Response Rate — 28.1; 53.8; 11.1 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Overall Response Rate |
28.1; 53.8; 11.1 | — |
| PRIMARY Duration of Response |
2.4; 13.3; NA | — |
| PRIMARY Overall Survival |
7.3; NA; 31.5 | — |
Eligibility Criteria
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 = 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 = = 50, 000/mm3 (> 20,000/mm3 for patients with thrombocytopenia due to bone marrow involvement)
Data sourced from ClinicalTrials.gov (NCT00290472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.