Clinical trial · Interventional
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
A Trial of Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in CD20+, B-cell Lymphomas, Gray Zone Lymphoma, and Hodgkin's Lymphoma
NCT01665768CI-TRIAL-00054670completedPhase 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)
This research is being done to determine if combining an investigational drug called Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose chemotherapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD20+, B-cell Lymphomas | — | UNRESOLVED | — |
| Gray Zone Lymphoma | Gray-Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL) | — | UNRESOLVED | — |
| Transformed Lymphoma/DLBCL/PMBCL | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus and Rituximab
- description
- Everolimus daily for one year and IV rituximab four times during that year.
- interventionNames
- Drug: Everolimus
- Biological: Rituximab
Primary outcomes (1)
- measure
- Safety as Assessed by Avoidance of Grade 3-4 Adverse Events
- timeFrame
- Up to 3 years
- description
- Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0.
Secondary outcomes (3)
- measure
- Event Free Survival (EFS)
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years of age * ECOG performance status ≤ 2 * INR ≤ 2 * Adequate renal and hepatic function defined as a serum creatinine \<2.0mg/dL, total bilirubin \<5mg/dL, and AST and ALT ˂ 2.5 ULN. * Platelet count \>75 x 109/L * Hemoglobin \>10mg/dL * ANC \>3.0x109/L * Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. * A willingness to use an accepted and effective method of birth control for sexually active women of childbearing potential during the study and for 8 weeks after the end of study drug treatment. * Ability to sign informed consent Exclusion Criteria: Patient who have previously received an mTor inhibitor * Patients who are pre-terminal or moribund * Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of Everolimus (including chemotherapy, radiation therapy, antibody based therapy, etc.) * Uncontrolled diabetes mellitus as defined by HbA1c\>8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary * Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled cortosteroids are allowed * Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines; * Patients who have a history of another primary solild malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for ≥3 years; * Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study; * Patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection * Female patients who are pregnant or breast feeding, or of reproductive potential whoe are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug. * Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment * Patients with known intolerance to rituximab * Known history of HIV or Hepatitis C * Active Hepatitis B as defined by seropositivity for hepatitis B surface antigen. Subjects with positive hepatitis B core antibody titers and normal liver transaminases are allowed provided that prophylaxis is administered per institutional guidelines. Please see Addendum 8 for the action to be taken for patients with positive baseline hepatitis B results.
References
Publications (1)
- RESULTSchoch LK, Asiama A, Zahurak M, Shanbhag S, Hurtt J, Sawyer K, Swinnen LJ, Wagner-Johnston N, Jones RJ, Ambinder RF, Gladstone DE. Pharmacokinetically-targeted dosed everolimus maintenance therapy in lymphoma patients. Cancer Chemother Pharmacol. 2018 Feb;81(2):347-354. doi: 10.1007/s00280-017-3499-y. Epub 2017 Dec 13. PMID 29234922