Phase 2
Completed N=22
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
Source: ClinicalTrials.gov NCT00450801 ↗Enrolled (actual)
22
Serious AEs
95.3%
Results posted
Nov 2015
Primary outcomePrimary: Progression-free Survival Rate — 91; 78; 69 percentage of participants
Summary
RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival Rate |
91; 78; 69 | — |
| SECONDARY Overall Survival Rate |
96; 96; 96; 87; 87 | — |
| SECONDARY Response Rate |
100 | — |
| SECONDARY Number of Patients Experiencing Adverse Events. |
22; 22; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Previously untreated, histologically confirmed mantle cell lymphoma.
- Measurable or evaluable disease.
- All stages are eligible.
- Age > 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Adequate hepatic function:
- Bilirubin < 3 mg/dL.
- Transaminases (SGOT and/or SGPT) < than 2.5 times the upper limit of normal for the institution, unless due to lymphomatous involvement.
- Serum creatinine < 1.5 mg/Dl.
- Ability to give informed consent.
- Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
- Life expectancy greater than 6 months.
Exclusion Criteria
- Previous chemotherapy, immunotherapy or radiotherapy for this lymphoma
- Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
- Grade 3 or 4 cardiac failure and/or ejection fraction < 50.
- Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
- Patients with a known history of HIV or AIDS
- Presence of hepatitis or hepatitis B virus (HBV) infection
- Pregnant or breast-feeding women.
- Central nervous system (CNS) involvement
Data sourced from ClinicalTrials.gov (NCT00450801). 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.