Non-Myeloablative Allogeneic Stem Cell Transplantation

NCT00525876 | Completed Results

• 1 other identifier: 2004-0309
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine the safety and efficacy of non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for patients with advanced or recurrent mantle cell lymphoma.
2. 2.To determine factors associated with response and durable remission in patients receiving rituximab, cyclophosphamide, and fludarabine in preparation for allogeneic stem cell transplantation.

Conditions

Lymphoma

Keywords

Mantle Cell Lymphoma; Lymphoma; Allogeneic Stem Cell Transplant; Rituximab; Cyclophosphamide; Neosar; Cytoxan; Fludarabine; Fludara; Fludarabine phosphate; Rituxan; Alemtuzumab; CAMPATH-1H; Campath; Total Body Irradiation; TBI

Outcome Measures

Primary Outcomes (1)

• Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)

  Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma.

  100 days post transplant

Study Arms (2)

Matched Sibling Transplant

EXPERIMENTAL

Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab; Procedure: Allogeneic Stem Cell Infusion

Allo MUD & MM

EXPERIMENTAL

Allo MUD \& MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Rituximab; Drug: Alemtuzumab; Procedure: Allogeneic Stem Cell Infusion

Interventions

Cyclophosphamide DRUG

Matched Donors: 750 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine. Unrelated or Mismatched Donors: 1000 mg/m\^2 given intravenously on Day -3, 4 hours after completion of Fludarabine. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)

Also known as: Cytoxan, Neosar

Allo MUD & MM; Matched Sibling Transplant

Fludarabine DRUG

30 mg/m\^2 given intravenously on Days -5 and -3 before transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)

Also known as: Fludarabine phosphate, Fludara

Allo MUD & MM; Matched Sibling Transplant

Rituximab DRUG

Matched Donors: 375 mg/m\^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation. Unrelated/Mismatched Donors: 375 mg/m\^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0) For development of disease progression or no response, immunomanipulation with Rituximab 375 mg/m\^2 given intravenously, then 1000 mg/m\^2 given intravenously weekly for 3 weeks, and taper off Tacrolimus dose over 2 weeks. DLI = Donor Lymphocyte Infusion/Immunomodulation Post Transplantation Immunomodulation for patients with lymphoid Malignancies: 375 mg/m\^2 then 1000 mg/m\^2 weekly x 3 if immunomanipulation is undertaken for persistent disease.

Also known as: Rituxan

Allo MUD & MM; Matched Sibling Transplant

Alemtuzumab DRUG

Unrelated/Mismatched Donors: 15 mg per day given intravenously days 1 through 3 after transplantation. (Stem Cell Transplantation and Low Dose Total Body Irradiation = Day 0)

Also known as: CAMPATH-1H, Campath

Allo MUD & MM

Allogeneic Stem Cell Infusion PROCEDURE

Infusion of stem cells.

Also known as: ASCT

Allo MUD & MM; Matched Sibling Transplant

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients can be as old as 70 years.
• They must have a diagnosis of MCL, either (1) Recurrent, (2) Newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated B\^2 microglobulin (\> 3).
• Patients that have received prior conventional chemotherapy but have not achieved complete response (CR).
• Disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
• Patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
• Patients must have a matched or 1 antigen mismatched sibling or unrelated donor.
• Point Scale (PS) \</= 2.

You may not qualify if:

• Past history of anaphylaxis following exposure to rat- or mouse-derived CDR-grafted humanized monoclonal antibodies.
• Less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.
• Pregnancy or lactation.
• HIV or HTLV-I positivity.
• Serum creatinine concentration \> 1.6 mg/dl or serum bilirubin \> 2.0 mg/dl unless due to tumor
• pulmonary function test - carbon monoxide diffusing capacity \< 40%
• cardiac ejection fraction \< 40% of predicted levels (by multiple-gated acquisition or echocardiography).
• Severe concomitant medical or psychiatric illness.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

Cyclophosphamide; fludarabine; fludarabine phosphate; Rituximab; Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Results Point of Contact

• Title: Issa F. Khouri, MD/ Professor
• Organization: UT MD Anderson Cancer Center

celsaenz@mdanderson.org

Study Officials

• Issa F. Khouri, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: January 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 7, 2011
• Results First Posted: December 7, 2011

Record last verified: 2011-11

Locations

US (1)