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A Phase II Study of Dose Augmented Rituximab and Ice for Patients With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell Non-Hodgkin's Lymphoma Undergoing Second-Line Therapy Prior to Stem Cell Transplantation


Phase 2
18 Years
72 Years
Not Enrolling
Both
Lymphoma, B-cell Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase II Study of Dose Augmented Rituximab and Ice for Patients With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell Non-Hodgkin's Lymphoma Undergoing Second-Line Therapy Prior to Stem Cell Transplantation


The purpose of this study is to determine if dose escalation of the rituximab-ICE (RICEesc)
program can improve the overall response rate of patients with primary refractory or poor
risk relapsed aggressive B cell lymphoma. R-ICEesc will be administered for 2 cycles with
peripheral blood progenitor cells (PBPCs) collected after cycle 2.

A two-stage design will be employed, such that the study will be terminated if in the first
cohort of patients it appears that the overall response rate is <50% or if >25% patients
fail to mobilize at least 2 x 106 CD34+ cells/kg.


Inclusion Criteria:



- Histologic diagnosis of the one of the following B cell aggressive lymphomas,
confirmed by an MSKCC pathologist: Diffuse Large, Immunoblastic, Mantle cell,
Anaplastic Large Cell, De novo transformation of follicular lymphoma, or classical
Hodgkin's lymphoma which is CD20 antigen positive.

- Tumors must stain positive for CD20.

- Primary refractory disease proven by biopsy or fine needle aspiration (cytology) of
an involved site

- Relapsed diffuse large, immunoblastic, anaplastic, de novo transformation of
follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive
proven by biopsy or fine needle aspiration (cytology) of an involved field site and
at least two of the three following risk factors: LDH> upper limit of normal, KPS <
80%, Stage III or IV disease.

- All mantle cell lymphoma patients in first relapse

- Failure of doxorubicin or mitoxantrone containing front-line therapy

- Bidimensionally measurable disease.

- Cardiac ejection fraction of greater than 50%, measured since last chemotherapy.

- Serum creatinine <1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12- or
24-hour creatinine clearance must be >60 ml/minute.

- ANC>1000/µl and Platelets>50,000/µl

- Total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease.

- Females of childbearing age must be on an acceptable form of birth control.

- Age between 18 and 72

- HIV I and II negative.

- Patients or their guardians must be capable of providing informed consent.

Exclusion Criteria:

- Any lymphoma subtype other than those described among the inclusion criteria.

- All patients with relapsed diffuse large, immunoblastic, anaplastic, de novo
transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20
antigen positive disease who have <2 of following risk factors: LDH> upper limit of
normal, KPS < 80%, Stage III or IV disease.

- History of second-line chemotherapy

- Presence of CNS involvement.

- Prior treatment with carboplatin, cisplatin, ifosfamide, or etoposide

- Hepatitis B surface antigen positive.

- Known pregnancy or breast-feeding.

- Medical illness unrelated to NHL, which in the opinion of the attending physician
and/or principal investigator will preclude administering chemotherapy safely.

- History of any malignancy for which the disease-free interval is <5 years, excluding
curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma
in-situ of the cervix

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the ability R-ICEesc chemotherapy to improve the overall response rate in primary refractory or poor risk relapsed aggressive B cell lymphoma patients from 50% to 70%

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Craig Moskowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-075

NCT ID:

NCT00588094

Start Date:

October 2003

Completion Date:

March 2010

Related Keywords:

  • Lymphoma
  • B-cell Non-Hodgkin's Lymphoma
  • Lymphoma
  • ASCT
  • B-cell non-Hodgkin's lymphoma
  • Cancer
  • Second line therapy
  • ICE
  • Stem cell transplant
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021