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Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Mantle Cell Lymphoma

Thank you

Trial Information

Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose (MTD)

Outcome Description:

of HIDAC. For this study the MTD will be the dose at which no more than one grade 3 CNS toxic event (defined by CTCAE 4.0 as severe neurologic symptoms limiting self care ADLs') up to two weeks following HIDAC occurs among a 6 patient cohort. Phase I

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Andrew Zelenetz, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-095

NCT ID:

NCT01484093

Start Date:

November 2011

Completion Date:

November 2014

Related Keywords:

  • Mantle Cell Lymphoma
  • CYCLOPHOSPHAMIDE (CYTOXAN)
  • CYTARABINE (ARA-C)
  • DOXORUBICIN/ADRIAMYCIN
  • PREDNISONE
  • RITUXIMAB
  • TOSITUMOMAB (BEXXAR)
  • Iodine
  • VINCRISTIN
  • Lymphoma
  • Chemo-Radioimmunotherapy
  • Autologous Transplantation
  • Untreated
  • 11-095
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York