Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma

NCT02633137 | Completed Phase 2 Results

• 1 other identifier: 15-196
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, the treatment including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has on the participant and their lymphoma.

Conditions

Mantle Cell Lymphoma; Untreated

Keywords

Lenalidomide; 15-196

Outcome Measures

Primary Outcomes (1)

• 3-year Progression-free Survival (PFS)

  acceptable 3-yr PFS as 75% or higher, and unacceptable rate as 60% or lower.

  3 years

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Lenalidomide + R-CHOP x 4 cycles R-HiDAC x 2 cycles R-Len maintenance x 6 months. Patients will be followed on active follow up for three years after completion of therapy. After the active followup period, survival, relapse, and new anti-lymphoma therapy information will be collected via telephone calls, patient medical records, and/or clinic visits approximately every 6 months until death, loss to follow up or consent withdrawal, whichever comes first.

Drug: Lenalidomide; Drug: R-CHOP; Drug: high-dose cytarabine (HIDAC)

Interventions

Lenalidomide DRUG

Chemotherapy

R-CHOP DRUG

* Rituximab 375 mg/m\^2 IVPB with premedications Day 1 * Cyclophosphamide 750 mg/m\^2 IVPB Day 1 * Doxorubicin 50 mg/m\^2 IVP Day 1 * Vincristine 1.4 mg/m\^2 IVP (capped at 2 mg) Day 1 * Prednisone 100 mg PO Daily on Days 1-5 or 2-6

Chemotherapy

high-dose cytarabine (HIDAC) DRUG

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated mantle cell lymphoma patients (at least clinical stage 2)
• Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma
• Presence of evaluable disease
• Age ≥18 years KPS ≥ 70%
• Adequate organ function: ANC ≥1500 and platelet count ≥100,000, unless felt to be secondary to underlying mantle cell lymphoma
• Renal function assessed by calculated creatinine clearance as follows:
• Cockcroft-Gault estimation of CrCl):
• Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥30ml/min and \< 60ml/min.
• Adequate hepatic function as determined by
• Total bilirubin \<1.5X upper limit of normal (ULN) (unless known Gilbert syndrome)
• AST (SGOT) and ALT (SGPT) 3 x ULN
• All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
• Each subject must sign an informed consent form indicating that he or she understand the purpose of and procedures required for the study and are willing to participate.
• Short course systemic corticosteroids is permissible for disease control, improvement of performance status or non-cancer indication if ≤ 10 days and must be discontinued prior to study treatment.

You may not qualify if:

• Known central nervous system (CNS) lymphoma
• Uncontrolled or severe cardiovascular disease or left ventricular ejection fraction \<50% as determined by echocardiogram or MUGA.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
• Pregnant or breast-feeding. Pre-menopausal patients must have a negative serum HCG within 14 days of enrollment.
• Patients using ≥20 mg/day of prednisone (or steroid equivalent dose) for any chronic medical condition
• Known seropositive, requiring anti-viral therapy, and with detectable viral load by PCR for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Known hypersensitivity to thalidomide or lenalidomide
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Patients planned for upfront consolidation with high-dose therapy and autologous stem cell transplant.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Lenalidomide; R-CHOP protocol; Cytarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Anita Kumar, MD
• Organization: Memorial Sloan Kettering Cancer Center

kumara2@mskcc.org

646-608-3780

Study Officials

• Anita Kumar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: December 14, 2015
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2023-11

Locations

US (7)