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Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Mantle Cell Lymphoma

Thank you

Trial Information

Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation


Inclusion Criteria:



- Age 18 years or older

- Mantle Cell Lymphoma according to REAL/WHO classification

- First or second relapse or alternatively progression during therapy. Previous use of
Bendamustine is permitted, if the patient has reached at least partial remission and
progression occured more than 6 months after therapy. Previous high dose chemotherapy
with auto-SCT is permitted, if the patient has reached at least partial remission and
progression occured more than 12 months after therapy.

- Patients must not be eligible for high dose chemotherapy with auto-SCT or allo-SCT.

- Adequate bone marrow function (hemoglobin > 9g/dl, platelet count >100/nL, absolute
neutrophil count >1,5 /nL)

- WHO/ECOG Performance Status 0-2

- Measurable disease (two perpendicular diameters by either physical or radiological
examination)

- Life expectancy ≥ 3 weeks

- Written informed consent

Exclusion Criteria:

- Prior treatment with any m-TOR Inhibitor

- Unstable or severe uncontrolled medical condition (e.g. severe congestive heart
failure, myocardial infarction within the past 6 months, severe, uncontrolled
arterial hypertension, renal insufficiency requiring hemodialysis, severe pulmonary
disease, severe diabetes)

- Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal
(ULN)

- Abnormal renal function: serum creatinine > 2 x upper limit of normal

- Previous malignancy other than non-melanoma skin cancer or carcinoma in situ of the
cervix.

- Concurrent treatment with strong inhibitors of CYP3A4 and/or inducers of CYP3A4

- Pregnant or breastfeeding women (negative pregnancy test not older than 7 days is
required for women of fertile age). Men and women of child-bearing potential must
agree to use adequate contraception (i.e. failure rate < 1% p.a. )

- Major surgery within 4 weeks before study entry; minor procedures (e.g. Implantation
i.v. port catheter, Lymphnode biopsy) within 1 week before study entry

- Previous therapy with any investigational agents within 28 days before study entry

- Concomitant immunotherapy (e.g. Rituximab) or Chemotherapy other than Bendamustine.
Use of systemic steroids should be documented and the Principal Investigator be
informed.

- Central nervous system (CNS) lymphomatous involvement

- HIV positivity

- Current or chronic hepatitis B or hepatitis C infection

- Severe psychiatric illness or Individuals that are placed in an institution due to a
magisterial or judiciary command.

- Inability to comply with study requirements

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase I: Dose-finding

Outcome Description:

Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Christian Scholz, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EudraCT-No.: 2009-014844-13

NCT ID:

NCT01170052

Start Date:

May 2010

Completion Date:

April 2014

Related Keywords:

  • Mantle Cell Lymphoma
  • Relapsed Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Non-Hodgkins Lymphoma
  • Temsirolimus
  • Bendamustine
  • Phase 1/2
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

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