Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-Line Rituximab-Chemotherapy - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00790036

Purpose

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapy

Condition	Intervention	Phase
Diffuse Large B-Cell Lymphoma	Drug: RAD001 Drug: Placebo	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-Line Rituximab-Chemotherapy

Further study details as provided by Novartis:

Primary Outcome Measures:

Disease-free survival (DFS): Disease-free survival (DFS) is the time from date of randomization to the date of event defined as the first documented recurrence of the disease or death due to any cause. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incidence of adverse events, serious adverse events, changes from baseline in vital signs and laboratory results (hematology, blood chemistry and urinalysis). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incidence of non-infectious pneumonitis. Chest CT scans or PET/CT scans will be performed at screening, at regular intervals, as clinically indicated if there is a suspicion of non-infectious pneumonitis, and at the end of the study. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (OS): Overall survival is defined as the time from date of randomization to date of death due to any cause. If the patient is not known to have died, survival will be censored at the date of the last contact. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Lymphoma-specific survival: Lymphoma-specific survival is defined as time from randomization to death as a result of lymphoma, which means that death must be recorded as a result of lymphoma. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	915
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: RAD001 RAD001 10 mg (two 5 mg tablets), daily for 12 months
2: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with previous histologically-confirmed Stage III-IV (or Stage II bulky disease) diffuse large B cell lymphoma (pathology report based on original tumor tissue/lymph node is acceptable for meeting inclusion criteria, but tumor tissue will be sent for central pathology review for confirmation).

Patients defined as poor risk with revised IPI of 3, 4, or 5. Patients age ≥ 18 years old. Patients must have achieved complete remission (CR) based on the modified IWRC (Cheson et al 2007) following first line R-CHOP treatment. Complete remission from R-CHOP must be confirmed by clinical and radiologic evaluation along with bone marrow confirmation (if bone marrow was involved by lymphoma before the R-CHOP treatment). Local pathology report on the bone marrow biopsy is acceptable. If bone marrow was not involved by lymphoma before R-CHOP treatment, then bone marrow confirmation is not required.

Post R-CHOP radiologic complete remission (CT or MRI and PET) must be confirmed and documented by the central radiologic review before randomization.

Patients who received a minimum 6 cycles of R-CHOP treatment and maximum 8 cycles of R-CHOP treatment. Any variation of CHOP is acceptable.

Exclusion Criteria:

Patients with evidence of disease according to the modified IWRC (Cheson et al 2007, Novartis-modified Cheson criteria) after completion of the first-line R-CHOP treatment, prior to study entry.

Patients receiving ongoing radiation therapy or radiation therapy ≤ 3 weeks prior to the start of study drug, unless the acute side effects associated with such therapy have resolved.

Patients who have previously received systemic mTOR inhibitor (sirolimus, temsirolimus, everolimus, etc).

Patients with evidence of central nervous system (CNS) involvement. Patients with transformed follicular lymphoma. Patients who had myelosuppressive chemotherapy or biologic therapy < 3 weeks.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRAD001N2301, EUDRACT 2008-000498-40
Study First Received:	November 11, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790036
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Diffuse large B cell lymphoma
poor risk
R-IPI 3-5
adjuvant therapy
after R-CHOP

Study placed in the following topic categories:

Everolimus
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders

Rituximab
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009