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Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Rituximab, Gemcitabine, Oxaliplatin

About this trial

This is an interventional treatment trial for Refractory Aggressive Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01538641

First Posted

February 21, 2012

Last Updated

July 11, 2012

Sponsor

Auxilio Mutuo Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01538641

Brief Title

Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Auxilio Mutuo Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study Proposal: Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be explored in this group of disorders. Based on these data and considering the advantage of its favorable toxicity profile, we propose a phase II study in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including peripheral T-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive B-cell lymphomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Rituximab, Gemcitabine, Oxaliplatin

Intervention Description

Rituximab:375 mg/m2; on day 1 of each 14 days cycle. Gemcitabine:1,000 mg/m2 on day 2 of each 14 days cycle. Oxaliplatin:100 mg/m2; on day 2 of each 14 days cycle. Total number of cycles: 6 cycles.

Primary Outcome Measure Information:

Title

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

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas

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