Clinical trial NCT01484093: Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma
Official title: Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: CYCLOPHOSPHAMIDE (CYTOXAN)
CYTARABINE (ARA-C)
DOXORUBICIN/ADRIAMYCIN
PREDNISONE
RITUXIMAB
TOSITUMOMAB (BEXXAR)
Iodine
VINCRISTIN
Lymphoma
Chemo-Radioimmunotherapy
Autologous Transplantation
Untreated
11-095
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-12-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000 cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being done to better understand how to treat MCL.


Eligibility criteria: Inclusion Criteria:

* Previously untreated advanced stage mantle cell lymphoma (Clinical stage 2 with abdominal involvement, stage 3 and stage 4).
* Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma with Cyclin D1, or D2 and/or, D3 staining performed. Presence of measurable disease as determined by FDG-PET, CT, endoscopy, colonoscopy, or bone marrow biopsy.
* Ages 18-70.
* Transplant eligibility as confirmed by the Disease Management Team.
* KPS ≥ 70%.

Adequate organ function:

* WBC ANC ≥ 1000 cells/mcL and platelet count ≥ 100,000 cells/mcL unless felt to be secondary to underlying mantle cell lymphoma at which any count is permissible.
* Adequate renal function as determined by Cr \< or = to 1.5 mg/dL or 24 hr creatinine clearance ≥ 50 ml/hr
* Adequate hepatic function as determined by total bilirubin \< or = to 1.5x ULN (unless known Gilbert syndrome) and AST \< or = to 5.0x ULN.
* Cardiac ejection fraction greater than or equal to 50% as determined by echocardiogram or MUGA.
* For patients ≥ age 60, a stress echocardiogram will be required, with same requirements as above.
* DLCO greater than or equal to 50% as determined by pulmonary function tests performed prior to initiation of treatment.
* Patients with positive Hepatitis B serologies will be treated per institutional guidelines.

Exclusion Criteria:

* Prior treatment for mantle cell lymphoma, including more than 7 days of steroids, immunotherapy, radioimmunotherapy, or chemotherapy. This does not include patients who have initiated R-CHOP at an outside institution within 2 weeks of enrollment.
* Patients using \> or = to 10mg/day of steroids for any chronic medical condition
* Pregnant or breast-feeding. Note: Pre-menopausal patients must have a negative, serum HCG within 14 days of enrollment,.
* HIV positive or Hepatitis C antibody positive.

Primary outcomes:
measure: maximum tolerated dose (MTD)
timeFrame: 1 year
measure: 3 year Event Free Survival (EFS)
timeFrame: 3 years
Secondary outcomes:
measure: 3-year Event Free Survival (EFS)
timeFrame: 3 years
measure: rates of complete remission (CR)
timeFrame: 1 year
measure: Determine 3 year overall survival (OS).
timeFrame: 3 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrew Zelenetz, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Bantilan KS, Jacob AP, Park A, Schoninger SF, Sauter C, Ulaner GA, Casulo C, Faham M, Kong KA, Grewal RK, Gerecitano J, Hamilton A, Hamlin P, Matasar M, Moskowitz CH, Noy A, Palomba ML, Portlock CS, Younes A, Willis T, Zelenetz AD. Noninvasive Monitoring of Mantle Cell Lymphoma by Immunoglobulin Gene Next-Generation Sequencing in a Phase 2 Study of Sequential Chemoradioimmunotherapy Followed by Autologous Stem-Cell Rescue. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):230-237.e12. doi: 10.1016/j.clml.2020.09.007. Epub 2021 Jan 1.