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Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Phase II Study of Low Intensity Allogeneic Transplantation in Mantle Cell Lymphoma


OBJECTIVES:

Primary

- Determine progression-free survival in patients with mantle cell lymphoma undergoing
low-intensity allogeneic stem cell transplantation.

Secondary

- Determine overall survival of these patients.

- Determine the toxicity by way of adverse event profile of this regimen in these
patients.

OUTLINE: This is a multicenter study.

- Reduced intensity conditioning: Patients receive carmustine IV over 2 hours on day -6,
etoposide IV over 1 hour and cytarabine IV over 15 minutes on days -5 to -2,
alemtuzumab IV over 2 hours on days -5 to -1, and melphalan IV on day -1.

- Donor stem cell transplant: Patients undergo stem cell transplantation on day 0 with
filgrastim (G-CSF)-mobilized peripheral blood stem cells or bone marrow stem cells.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or
orally on day -1 to 30 and taper to day 100.

- Donor lymphocyte infusion (DLI) therapy: Patients with evidence of disease progression,
mixed chimerism, or low level residual disease undergo DLI every 3 months for up to 15
months in the absence of GVHD.

After completion of study, patients are followed every 3 months for 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of mantle cell lymphoma

- No relapsed or progressive disease

- Achieved at least a partial remission following induction chemotherapy

- HLA-matched donor available

- Blood samples from both patient and donor available for chimerism studies

- No central nervous system involvement

PATIENT CHARACTERISTICS:

- ECOG performance status 2-4

- Considered fit for transplant by treating physician

- Serum bilirubin ≤ 1.5 times upper limit of normal

- Alkaline phosphatase ≤ 2 times normal

- Creatinine clearance ≥ 50 mL/min

- Ejection fraction > 50% (no inadequate cardiac function)

- Not pregnant or nursing

- Negative pregnancy test

- No symptomatic respiratory compromise

- No serious concurrent disease which would preclude allograft

- No known serological positivity for hepatitis B, hepatitis C, or HIV

- No history of a psychological illness or condition that would affect compliance

- No previous malignancy within the past 5 years except nonmelanoma skin tumors or
stage 0 (in situ) cervical carcinoma

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Simon Rule, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Derriford Hospital

Authority:

Unspecified

Study ID:

CDR0000597903

NCT ID:

NCT00720447

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

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