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A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Follicular Lymphoma

Thank you

Trial Information

A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma


Patients will receive six cycles of combination chemotherapy, C-MOPP-R, typically through a
subcutaneous PORT. This combination chemotherapy will last six months. After the last dose
of chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem
cell mobilization from peripheral blood with subcutaneous injections of neupogen and
mozobil. Patients then receive Zevalin radioimmunotherapy, and this is followed after
recovery of blood counts, typically 3 months later, by an autologous stem cell transplant.


Inclusion Criteria:



- Patients older than 18 years of age

- Follicular lymphoma, newly diagnosed or previously treated but no more than 2
previous regimens

- Relapse of disease must be greater than 6 months after last chemotherapy

- Stages II, III or IV

- Eastern Cooperative Group (ECOG) performance status of 0 or 1. If ECOG 2-4, poor
performance must by due to lymphoma as judged by study investigator.

- Patient signed written informed consent

- Adequate renal function defined as a glomerular filtration rate (GFR) > 60 ml/min

- Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless
low due to lymphomatous involvement of the bone marrow.

- No known allergies to the chemotherapeutic agents

- No other major disabling co morbidities

- Adequate pulmonary function, defined as corrected DLCO greater than 70% of predicted
and FEV1 (forced expiratory volume in one second, a test of respiratory function)
greater than 50% of predicted.

- Adequate hepatic function as assessed by study investigator

- Adequate cardiac function, defined as baseline MUGA (Multiple gated acquisition, a
test of heart function) >50%

Exclusion Criteria:

- Stage I follicular lymphoma

- ECOG performance status ≥ 2, unless due to lymphoma

- Patient refuses to sign written informed consent

- Poor renal function defined as GFR <60ml/min

- Abnormal liver function as assessed by study investigator

- Poor bone marrow reserve (absolute neutrophil count <1,500 and/or platelets <
100,000) not attributable to lymphomatous involvement of the bone marrow.

- Hypersensitivity to the chemotherapeutic agents

- Major disabling co morbidities like uncontrolled severe HTN (hypertension), active
coronary artery disease, liver cirrhosis.

- Previously diagnosed malignancy other than basal or squamous cell carcinoma of the
skin diagnosed <5 years prior.

- Central nervous system disease

- History of advanced cardiac disease (Active angina, Congestive heart failure with a
LVEF (left ventricular ejection fraction) <50%).

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:

Disease-free survival percentage(intention to treat)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Paul J Petruska, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Louis University

Authority:

United States: Institutional Review Board

Study ID:

IRB #14228

NCT ID:

NCT01130194

Start Date:

July 2006

Completion Date:

July 2026

Related Keywords:

  • Follicular Lymphoma
  • follicular lymphoma
  • radioimmunotherapy
  • rituximab
  • C-MOPP-R
  • autologous transplant
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Saint Louis University Cancer CenterSaint Louis, Missouri  63110