Brief Summary

This phase I/II trial studies the side effects and best dose of temsirolimus when given together with cladribine and rituximab and to see how well it works in treating patients with newly diagnosed mantle cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with cladribine and rituximab may kill more cancer cells.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline

Completed

Started Apr 2009

Longer than P75 for phase_1 lymphoma

Geographic Reach

1 country

144 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.2 years study duration

First Submitted

Initial submission to the registry

November 7, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed

5 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed

Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

November 7, 2008

Last Update Submit

January 8, 2018

Conditions

Lymphoma

Keywords

stage I mantle cell lymphomaStage II Contiguous Mantle Cell LymphomaStage II Non-Contiguous Mantle Cell LymphomaStage III Mantle Cell LymphomaStage IV Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

Number of dose limiting toxicity incidents as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 3.0 (Phase I)
28 days
Proportion of complete tumor responses defined as complete remission (CR) as the objective status (Phase II)
Up to 5 years

Secondary Outcomes (6)

Overall survival
up to 5 years
Progression-free survival (PFS)
up to 5 years
Time to disease progression
up to 5 years
Duration of response, defined as date at which the patient's objective status is first noted to be either a CR or partial remission to the date progression is documented
Up to 5 years
Survival time
Up to 5 years
+1 more secondary outcomes

Study Arms (1)

Treatment (rituximab, cladribine, temsirolimus)

EXPERIMENTAL

Patients receive rituximab IV on day 1 and cladribine IV over 2 hours on days 1-5. Patients then receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive filgrastim SC on days 6-15 or pegfilgrastim SC on day 6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Biological: rituximabDrug: cladribineDrug: temsirolimusBiological: FilgrastimBiological: Pegfilgrastim