Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00720447
• Other study ID #: UCL-BRD-07-137
• Secondary ID: CDR0000597903EUD
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 19, 2008
• Last updated: August 1, 2013
• Start date: November 2008

Study information

• Verified date: July 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with mantle cell lymphoma.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Biological:
• alemtuzumab

• donor lymphocytes

Drug:
• carmustine

• cytarabine

• etoposide

• melphalan

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival			No
Secondary	Overall survival			No
Secondary	Toxicity			Yes