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Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma


OBJECTIVES:

Primary

- Determine the efficacy of gemcitabine, in terms of objective response and tolerability,
in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell
lymphoma.

Secondary

- Determine the time to progression and time to treatment failure in patients treated
with this drug.

- Determine the response duration in patients treated with this drug.

- Determine the adverse reactions in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3
weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria:

- Newly diagnosed

- Chemotherapy resistant

- Relapsed disease after no more than 2 prior lines of chemotherapy

- Measurable disease

- At least 1 unidimensionally measurable lesion ≥ 11 mm by CT scan

- No prior or current CNS lymphoma or lymphomatous meningosis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- WHO 0-1

Life expectancy

- Not specified

Hematopoietic

- Neutrophil count ≥ 1,500/mm^3 (1,000/mm^3 in case of bone marrow infiltration)

- Platelet count ≥ 100,000/mm^3 (75,000/mm^3 in case of bone marrow infiltration)

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2 times ULN

- AST and ALT ≤ 2 times ULN

- No active hepatitis

Renal

- Creatinine clearance ≥ 50 mL/min

Cardiovascular

- No congestive heart failure

- No New York Heart Association class III or IV heart disease

- No unstable angina pectoris

- No significant cardiac arrhythmia or arrhythmia requiring chronic treatment

- No myocardial infarction within the past 3 months

Immunologic

- No active autoimmune disease

- No ongoing infection (e.g., HIV)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 12 months after
study participation

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
adequately treated carcinoma in situ of the cervix

- No uncontrolled diabetes mellitus

- No gastric ulcers

- No other uncontrolled medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent thalidomide

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Prior radiotherapy allowed provided indicator lesions were not in the irradiated
field

- No concurrent radiotherapy to the lungs or mediastinum

Surgery

- Not specified

Other

- More than 30 days since prior systemic anticancer treatment

- More than 30 days since prior clinical trial participation

- No other concurrent anticancer drugs

- No other concurrent experimental drugs

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response at end of study treatment

Safety Issue:

No

Principal Investigator

Felicitas Hitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital St. Gallen

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 36/03

NCT ID:

NCT00234026

Start Date:

June 2005

Completion Date:

March 2006

Related Keywords:

  • Lymphoma
  • recurrent mantle cell lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

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