Know Cancer

or
forgot password

A Phase I Trial of Clofarabine in Combination With High-Dose Etoposide and Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation for Patients With High-Risk or Refractory Non-Hodgkin's Lymphoma


Phase 1
18 Years
70 Years
Not Enrolling
Both
Non Hodgkin's Lymphoma

Thank you

Trial Information

A Phase I Trial of Clofarabine in Combination With High-Dose Etoposide and Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation for Patients With High-Risk or Refractory Non-Hodgkin's Lymphoma


All patients will receive the same doses of etoposide and cyclophosphamide. The dose of
clofarabine will be escalated in successive cohorts of patients. Using a standard dose
escalation design, successive cohorts of 3 patients will be treated with escalating doses of
clofarabine (see Section 5.5 below). At the MTD (or highest dose-level if the MTD is not
reached), the cohort will be expanded to 10 patients to better investigate correlative
studies and give some preliminary idea of efficacy.


Inclusion Criteria:



1. Documentation of disease. Patients must have one of the following disease types:

- Diffuse large cell non-Hodgkin's lymphoma, mediastinal B-cell lymphoma, or
peripheral T-cell lymphoma that is:

- Primary refractory (achievement less than complete response)

- Relapsed and refractory (achievement less than a partial response) to at
least a single salvage therapy

- Relapsed or primary refractory Follicular lymphoma (FL) with a high FL
International Prognostic Index.

- Large cell transformation of lymphoma from a more indolent lymphoma (e.g.,
follicular, marginal zone, etc.)

- Mantle cell lymphoma that is:

- Primary Refractory (achievement less than complete response)

- Relapsed (regardless of chemosensitivity of relapsed disease)

2. Patients who received prior autologous stem cell transplantation are not eligible.

3. Patient age 18-70 years

4. Performance status ECOG 0-1

5. Required baseline laboratory values:

- LVEF > 45% corrected

- DLCO > 50% of predicted value (corrected for hemoglobin)

- Serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min

- Bilirubin < 1 x upper limit of normal value.

- AST and ALT < 1 x upper limit of normal value.

6. Signed written informed consent. Patient must be capable of understanding the
investigational nature of the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent

Exclusion Criteria:

1. No active infection. Patients with active infections requiring oral or intravenous
antibiotics are not eligible for enrollment until resolution of infection.

2. No HIV disease. Patients with immune dysfunction are at a significantly higher risk
of infection from intensive immunosuppressive therapies.

3. Non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to
significant risks. Women of childbearing potential should have a negative pregnancy
test prior to study entry. Women and men of reproductive potential should agree to
use an appropriate method of birth control throughout their participation in this
study due to the teratogenic potential of the therapy utilized in this trial.
Appropriate methods of birth control include oral contraceptives, implantable
hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus
condom).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose (MTD) of clofarabine in association with high-dose etoposide and cyclophosphamide followed by ASCT in patients with refractory lymphoma malignancies.

Outcome Time Frame:

1 yr

Safety Issue:

Yes

Principal Investigator

Sherif Farag, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

0704-29 IUCRO-0187

NCT ID:

NCT00477945

Start Date:

May 2007

Completion Date:

November 2010

Related Keywords:

  • Non Hodgkin's Lymphoma
  • Non Hodgkin's Lymphoma
  • High Risk or Refractory Non Hodgkin's Lymphoma
  • APBSCT
  • clofarabine
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Indiana University Cancer Center Indianapolis, Indiana  46202-5265