Know Cancer

or
forgot password

Phase II Evaluation Of GROC (Gemcitabine- Rituximab-Oxaliplatin Combination) Given Every 14 Days For The Treatment Of Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Aggressive Non-Hodgkin's Lymphoma, Relapsing Aggressive Non-Hodgkin's Lymphoma

Thank you

Trial Information

Phase II Evaluation Of GROC (Gemcitabine- Rituximab-Oxaliplatin Combination) Given Every 14 Days For The Treatment Of Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Patients with refractory or relapsed aggressive non-Hodgkin's Lymphoma. The
definition of refractory includes patients who either did not respond to prior
therapy or those whose best response was a PR after at least 4 courses of
chemotherapy. Aggressive histologies include follicular large cell, diffuse large
cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and
Burkitt like lymphomas.

- Histologic or cytological confirmation of refractory or relapsed aggressive
non-Hodgkin's Lymphoma is desirable but not mandatory and will be left to the
discretion of the investigator.

- Must have measurable or evaluable disease.

- No more than 4 previous regimens of chemotherapy will be allowed, including stem cell
or bone marrow transplant.

- Patients must be more than 18 years old.

- No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix-
toxicity criteria)

- Written Consent

- Those patients who have previously received a platinum or nucleoside
analogue-containing regimen are eligible.

- Patients who are candidates for stem cell or marrow transplant will be included

Exclusion Criteria:

- Patients with a previous or concurrent history of cancer with the exception of:
1-treated carcinoma in situ of cervix or breast. 2- treated squamous or basal cell
skin cancer, or 3- any other surgically cured malignancy from which the patient has
been disease free for at least 5 years.

- HIV positive patients and those with Hepatitis B or C will be excluded from this
protocol.

- Patients with severe neuropathy will be excluded.

- Chemotherapy or Radiotherapy within the previous 3 weeks prior to entering study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The response rate of the combination of Gemcitabine-Oxaliplatin-Rituximab.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

CCAM-03-01

NCT ID:

NCT01538641

Start Date:

October 2003

Completion Date:

December 2008

Related Keywords:

  • Refractory Aggressive Non-Hodgkin's Lymphoma
  • Relapsing Aggressive Non-Hodgkin's Lymphoma
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location